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Discovery Opens Door to New Class of Medicines for RA »
"Research funded in part by the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases has identified an enzyme that modulates inflammation and joint damage in rheumatoid arthritis. The results, which appeared in the journal, "...
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Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
In the APC (Adenoma Prevention with Celecoxib) trial, the hazard ratio for the composite endpoint of cardiovascular death, MI, or stroke was 3.4 (95% CI 1.4 – 8.5) for CELEBREX 400 mg twice daily and 2.8 (95% CI 1.1 – 7.2) with CELEBREX 200 mg twice daily compared to placebo. Cumulative rates for this composite endpoint over 3 years were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively, compared to 0.9% (6/679 subjects) with placebo treatment. The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction [see Clinical Studies].
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as celecoxib, increases the risk of serious gastrointestinal (GI) events [see Gastrointestinal Bleeding, Ulceration, And Perforation].
Status Post Coronary Artery Bypass Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see CONTRAINDICATIONS].
Post-MI Patients
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of Celebrex in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Celebrex is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Gastrointestinal Bleeding, Ulceration, And Perforation
NSAIDs, including celecoxib cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with CELEBREX. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.
Risk Factors For GI Bleeding, Ulceration, And Perforation
Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants; or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status. Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.
Complicated and symptomatic ulcer rates were 0.78% at nine months for all patients in the CLASS trial, and 2.19% for the subgroup on low-dose ASA. Patients 65 years of age and older had an incidence of 1.40% at nine months, 3.06% when also taking ASA [see Clinical Studies].
Strategies to Minimize the GI Risks in NSAID-treated patients:
- Use the lowest effective dosage for the shortest possible duration.
- Avoid administration of more than one NSAID at a time.
- Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs.
- Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy.
- If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue CELEBREX until a serious GI adverse event is ruled out.
- In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding [see DRUG INTERACTIONS].
Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.
Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including celecoxib.
In controlled clinical trials of CELEBREX, the incidence of borderline elevations (greater than or equal to 1.2 times and less than 3 times the upper limit of normal) of liver associated enzymes was 6% for CELEBREX and 5% for placebo, and approximately 0.2% of patients taking CELEBREX and 0.3% of patients taking placebo had notable elevations of ALT and AST.
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue CELEBREX immediately, and perform a clinical evaluation of the patient.
NSAIDs, including CELEBREX can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics or loop diuretics may have impaired response to these therapies when taking NSAIDs [see DRUG INTERACTIONS].
The rates of hypertension from the CLASS trial in the CELEBREX, ibuprofen and diclofenac-treated patients were 2.4%, 4.2% and 2.5%, respectively [see Clinical Studies].
Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.
Heart Failure And Edema
The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately twofold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of celecoxib may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) [see DRUG INTERACTIONS].
In the CLASS study [see Clinical Studies], the Kaplan-Meier cumulative rates at 9 months of peripheral edema in patients on CELEBREX 400 mg twice daily (4-fold and 2-fold the recommended OA and RA doses, respectively), ibuprofen 800 mg three times daily and diclofenac 75 mg twice daily were 4.5%, 6.9% and 4.7%, respectively.
Avoid the use of CELEBREX in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If CELEBREX is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Renal Toxicity And Hyperkalemia
Renal Toxicity
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics, ACE-inhibitors or the ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
No information is available from controlled clinical studies regarding the use of CELEBREX in patients with advanced renal disease. The renal effects of CELEBREX may hasten the progression of renal dysfunction in patients with preexisting renal disease.
Correct volume status in dehydrated or hypovolemic patients prior to initiating CELEBREX. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of CELEBREX [see DRUG INTERACTIONS]. Avoid the use of CELEBREX in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. If CELEBREX is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.
Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic- hypoadosteronism state.
Anaphylactic Reactions
Celecoxib has been associated with anaphylactic reactions in patients with and without known hypersensitivity to celecoxib and in patients with aspirin sensitive asthma. Celebrex is a sulfonamide and both NSAIDs and sulfonamides may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people [see CONTRAINDICATIONS and Exacerbation Of Asthma Related To Aspirin Sensitivity].
Seek emergency help if any anaphylactic reaction occurs.
Exacerbation Of Asthma Related To Aspirin Sensitivity
A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, CELEBREX is contraindicated in patients with this form of aspirin sensitivity [see CONTRAINDICATIONS]. When CELEBREX is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.
Serious Skin Reactions
Serious skin reactions have occurred following treatment with Celebrex, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). These serious events may occur without warning and can be fatal.
Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of CELEBREX at the first appearance of skin rash or any other sign of hypersensitivity. CELEBREX is contraindicated in patients with previous serious skin reactions to NSAIDs [see CONTRAINDICATIONS].
Premature Closure Of Fetal Ductus Arteriosus
Celecoxib may cause premature closure of the ductus arteriosus. Avoid use of NSAIDs, including CELEBREX, in pregnant women starting at 30 weeks of gestation (third trimester) [see Use In Specific Populations].
Hematological Toxicity
Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with CELEBREX has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
In controlled clinical trials the incidence of anemia was 0.6% with CELEBREX and 0.4% with placebo. Patients on long-term treatment with CELEBREX should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss.
NSAIDs, including CELEBREX, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [see DRUG INTERACTIONS].
Masking Of Inflammation And Fever
The pharmacological activity of CELEBREX in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.
Laboratory Monitoring
Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically.
In controlled clinical trials, elevated BUN occurred more frequently in patients receiving CELEBREX compared with patients on placebo. This laboratory abnormality was also seen in patients who received comparator NSAIDs in these studies. The clinical significance of this abnormality has not been established.
Disseminated Intravascular Coagulation (DIC)
Because of the risk of disseminated intravascular coagulation with use of CELEBREX in pediatric patients with systemic onset JRA, monitor patients for signs and symptoms of abnormal clotting or bleeding, and inform patients and their caregivers to report symptoms as soon as possible.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with CELEBREX and periodically during the course of ongoing therapy.
Cardiovascular Thrombotic Events
Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see WARNINGS AND PRECAUTIONS].
Gastrointestinal Bleeding, Ulceration, And Perforation
Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see WARNINGS AND PRECAUTIONS].
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop CELEBREX and seek immediate medical therapy [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].
Heart Failure And Edema
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see WARNINGS AND PRECAUTIONS].
Anaphylactic Reactions
Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Serious Skin Reactions
Advise patients to stop CELEBREX immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [see WARNINGS AND PRECAUTIONS].
Female Fertility
Advise females of reproductive potential who desire pregnancy that NSAIDs, including CELEBREX, may be associated with a reversible delay in ovulation [see Use In Specific Populations].
Fetal Toxicity
Inform pregnant women to avoid use of CELEBREX and other NSAIDs starting at 30 weeks of gestation because of the risk of the premature closing of the fetal ductus arteriosus [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
Avoid Concomitant Use Of NSAIDs
Inform patients that the concomitant use of CELEBREX with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia.
Use Of NSAIDS And Low-Dose Aspirin
Inform patients not to use low-dose aspirin concomitantly with CELEBREX until they talk to their healthcare provider [see DRUG INTERACTIONS].
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Celecoxib was not carcinogenic in Sprague-Dawley rats given oral doses up to 200 mg/kg for males and 10 mg/kg for females (approximately 2-to 4-times the human exposure as measured by the AUC0-24 at 200 mg twice daily) or in mice given oral doses up to 25 mg/kg for males and 50 mg/kg for females (approximately equal to human exposure as measured by the AUC0-24 at 200 mg twice daily) for two years.
Celecoxib was not mutagenic in an Ames test and a mutation assay in Chinese hamster ovary (CHO) cells, nor clastogenic in a chromosome aberration assay in CHO cells and an in vivo micronucleus test in rat bone marrow.
Impairment Of Fertility
Celecoxib had no effect on male or female fertility or male reproductive function in rats at oral doses up to 600 mg/kg/day (approximately 11times human exposure at 200 mg twice daily based on the AUC0-24). At ≥ 50 mg/kg/day (approximately 6-times human exposure based on the AUC0-24 at 200 mg twice daily) there was increased preimplantation loss.
Use In Specific Populations
Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward.
Risk Summary
Use of NSAIDs, including CELEBREX, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including CELEBREX, in pregnant women starting at 30 weeks of gestation.
There are no adequate and well-controlled studies of CELEBREX in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose of 200 mg twice daily. In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD [see Data]. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and post-implantation loss.
Clinical Considerations
Labor or Delivery
There are no studies on the effects of CELEBREX during labor or delivery. In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.
Human Data
The available data do not establish the presence or absence of developmental toxicity related to the use of Celebrex.
Animal data
Celecoxib at oral doses ≥ 150 mg/kg/day (approximately 2 times the human exposure at 200 mg twice daily as measured by AUC0-24), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis. A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥ 30 mg/kg/day (approximately 6 times human exposure based on the AUC0-24 at 200 mg twice daily for RA) throughout organogenesis. In rats, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses at oral doses ≥ 50 mg/kg/day (approximately 6 times human exposure based on the AUC0-24 at 200 mg twice daily for RA).
Celecoxib produced no evidence of delayed labor or parturition at oral doses up to 100 mg/kg in rats (approximately 7-fold human exposure as measured by the AUC0-24 at 200 mg twice daily). The effects of CELEBREX on labor and delivery in pregnant women are unknown.
Risk Summary
Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of CELEBREX in breast milk. The calculated average daily infant dose was 10-40 mcg/kg/day, less than 1% of the weight-based therapeutic dose for a two-year old-child. A report of two breastfed infants 17 and 22 months of age did not show any adverse events. Caution should be exercised when CELEBREX is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CELEBREX and any potential adverse effects on the breastfed infant from the CELEBREX or from the underlying maternal condition.
Females And Males Of Reproductive Potential
Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including CELEBREX, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including CELEBREX, in women who have difficulties conceiving or who are undergoing investigation of infertility.
Pediatric Use
CELEBREX is approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older. Safety and efficacy have not been studied beyond six months in children. The long-term cardiovascular toxicity in children exposed to CELEBREX has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to CELEBREX or other COX-2 selective and nonselective NSAIDs [(see BOXED WARNING, WARNINGS AND PRECAUTIONS, and Clinical Studies].
The use of celecoxib in patients 2 years to 17 years of age with pauciarticular, polyarticular course JRA or in patients with systemic onset JRA was studied in a 12-week, double-blind, active controlled, pharmacokinetic, safety and efficacy study, with a 12-week open-label extension. Celecoxib has not been studied in patients under the age of 2 years, in patients with body weight less than 10 kg (22 lbs), and in patients with active systemic features. Patients with systemic onset JRA (without active systemic features) appear to be at risk for the development of abnormal coagulation laboratory tests. In some patients with systemic onset JRA, both celecoxib and naproxen were associated with mild prolongation of activated partial thromboplastin time (APTT) but not prothrombin time (PT). When NSAIDs including celecoxib are used in patients with systemic onset JRA, monitor patients for signs and symptoms of abnormal clotting or bleeding, due to the risk of disseminated intravascular coagulation. Patients with systemic onset JRA should be monitored for the development of abnormal coagulation tests [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Animal Toxicology, Clinical Studies].
Alternative therapies for treatment of JRA should be considered in pediatric patients identified to be CYP2C9 poor metabolizers [see Poor Metabolizers of CYP2C9 substrates].
Geriatric Use
Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see WARNINGS AND PRECAUTIONS].
Of the total number of patients who received CELEBREX in pre-approval clinical trials, more than 3,300 were 65-74 years of age, while approximately 1,300 additional patients were 75 years and over. No substantial differences in effectiveness were observed between these subjects and younger subjects. In clinical studies comparing renal function as measured by the GFR, BUN and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers. However, as with other NSAIDs, including those that selectively inhibit COX-2, there have been more spontaneous post-marketing reports of fatal GI events and acute renal failure in the elderly than in younger patients [see WARNINGS AND PRECAUTIONS].
Hepatic Impairment
The daily recommended dose of CELEBREX capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of CELEBREX in patients with severe hepatic impairment is not recommended [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
Renal Impairment
CELEBREX is not recommended in patients with severe renal insufficiency [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Poor Metabolizers Of CYP2C9 Substrates
In patients who are known or suspected to be poor CYP2C9 metabolizers (i.e., CYP2C9*3/*3), based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) administer CELEBREX starting with half the lowest recommended dose. Alternative management should be considered in JRA patients identified to be CYP2C9 poor metabolizers. [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/7/2016
Celebrex FDA Prescribing Information
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Patrick Garrity
Jul 29, 2016 at 8:00 PM
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Patrick Garrity
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Gabriel Rutledge
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Come out and support their cause!
Since abandoning his successful pizza delivery career in 2000, Gabriel's combination of talent, hard work, and lack of a fall back plan have made him into one of North America's finest touring comics. Although, honestly he hasn't done much in Mexico.
A past winner of the prestigious Seattle International Comedy Competition, Gabriel has made television appearances on Comedy Central's Live at Gotham, the nationally syndicated Comedy.TV, and Nickelodeon's Nickmom Night Out.
He is also a frequent guest on the Bob and Tom radio show, heard in over 150 cities.
He has performed at the HBO/TBS Comedy Festival in Las Vegas and The Great American Comedy Festival held in Johnny Carson's home town of Norfolk Nebraska.
He has made at least 4 people pee their pants.
Gabriel is a Capricorn. His favorite color is orange. His favorite food is ice cream. He has brown eyes and brown hair. He lives in Olympia Washington.
When no one else is around he likes to listen to "Styx Greatest Hits." He was born in 1973. He has two parents, two brothers, two daughters, one wife, one son, one mother-in-law, and one vasectomy. In 2nd grade Gabriel finished second in the school spelling bee. The word he lost on was "machine." Gabriel was voted "Most Inspirational" on his 9th grade baseball team. He graduated from high school in 1992 with a G.P.A. of 2.8. Gabriel is 5'11. He doesn't want you to know how much he weighs, but it's less than his high bowling score, which is 252.
August 19, 2016 at 8:00 PM Dwight York
"I hope you like jokes" may seem an absurd way for a comedian to begin a show but those are the words that comedian Dwight York uses to introduce himself to his audience each night. Then the joke-slinging begins and never ends until York says "goodnight" a couple hundred perfect one-liners later.
Dwight York performs at many of the nation's top comedy clubs and every summer headlines the Buffalo Chip Comedy Club at the annual Sturgis Motorcycle Rally. He has appeared at the Great American Comedy Festival, the Edinburgh Fringe Festival and was a two-time finalist in the San Francisco International Comedy Contest. In October of 2014, he placed 2nd at the Laughlin Laugh Fest.
York has also been a favorite guest on the nationally syndicated The Bob and Tom Show and was featured on their CD, You Guys Rock. York's CD Quickies (Stand Up! Records) can be heard on Sirius XM Satellite Radio's Raw Dog Comedy Channel and was rated a "top ten comedy release of the year" by The Serious Comedy Site. Laffspin Magazine says that Dwight York, as inventive as he is suggestive, is what Steven Wright would be if Wright had Robert Schimmel's blue streak, and that's a compliment to all three master comics.
August 26, 2016 at 8:00 PM HOMEGROWN COMEDY SPECIAL!Join us for a special event at Penguin's! Full line up of Local Comedians, including the winner of "Funniest Comedian in Iowa" AJ GRILL!
Andrew Cline
Mitch Banks
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Travis Bails
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September 02, 2016 at 7:30 PM Travis Howze - Funny Under Fire!Travis Howze is an internationally touring comedian and motivational speaker who spent 14 years in the military and emergency services as a U.S. Marine, Police Officer and Firefighter. Whether performing at corporate events and fundraisers to top comedy clubs, colleges and multiple tours overseas for our troops, Travis has become a comedic demand in multiple arena's and always leaves his audiences craving more!
Known as the military and emergency services voice of comedy, the topics of Travis' humor are limitless: from being raised in South Carolina to married life and fatherhood to his time in uniform and much more. Whether dodging bullets, chasing bad guys, or running into burning buildings, Travis is always FUNNY UNDER FIRE!
September 04, 2016 at 7:30 PM Brett EricksonBrett Erickson is a comedian based in Los Angeles, CA. As host of one of L.A.'s most popular weekly shows, Punch at the Pikey, Brett tackles the week's news with a bold and brash, tell-it-like-it-is style. Combining a razor-sharp wit with a lovably acerbic tongue, Brett takes on topics most comics are too afraid to go near. If you like your comedy in the tradition of Stanhope and Hicks, you'll love Brett.

subset: commoncrawl


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First, a private airplane, then bonds with 13%+ interest rate, what can you say?
How about the "WALTON" appointment to the board, most fake companies always use this tactic of using big name to board
Mr. Gurnee was the audit committee chair of the fraudulent company longtop.
Sigh, how boring. Shorts periodically run through the hallways doing a chicken little imitation. Can you at least come up with some new rubbish? I have learned asking for rubbish that makes any kind of sense is useless.
so now he is fooling the big houses in nyc in this climate where china stocks are under intense scrutiny. can't you think?
private plane can help shuttle prospective buyers from china to see usa properties. it is a lease, not a buy.
even for bkln project, they have "bond" that yield 10%.
xin is in trouble for sure because of one thing: low investor iq
stupid is right. Do you know how many times banks and brokerages have been fooled, especially by
Chinese companies? Or are they fooled? Did they just ignore slight irregularities to make money?
And in Asia, the regulators are now making them responsible. Go and google the article,
Like shops, IPO sponsors must be held liable for what they sell'. I know they are talking IPO's in this
article, but it includes all involvement with stocks on the HK exchange.


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Gazprom Surges on Possible China Gas Deal Before Hu Trip
OAO Gazprom jumped the most since February after China, the world's biggest energy consumer, said it may sign a deal to import Russian natural gas ahead of President Hu Jintao's visit later this month.
The shares climbed 4.5 percent to 204.65 rubles by the 6:45 p.m. close in Moscow, their biggest gain since Feb. 24.
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"The Russians have been playing hardball in negotiations and refusing to accept a lower price than that commanded for their gas in Europe," he said.


text:
I write this review still as a guest at this hotel. We arrived from our stay at Essaouira on rather cold and rainy day in Marrakech so we were looking forward to getting to the hotel and unwinding.
After walking for almost 10 minutes navigating the labyrinth of motorcycles, carts, bicycles we finally arrived at our riad.
Our first reaction was mixed as our host Bouchra seemed a little unwelcoming. After the customary mint tea we were shown our room. I was looking forward to seeing the room as I was impressed with a framed article from Vogue with an editorial featuring the Riad.
Room - we had a room on the ground floor which which opened out onto the courtyard. The room is long and narrow. The doorway is very low so we had to constantly remember to keep our heads bent to avoid getting a head injury. Lights in the toilet did not turn on. The bed linens looked like they had seen a great deal of use and needed to be thrown away. The hot water from the shower stayed hot for a few minutes and gradually got colder. The courtyard had birds nesting in a tree so we went to bed and woke up with the sound of birds which became annoying.
Breakfast is basic. Coffee, breads and jams. The food at the hotel is expensive compared to other restaurants in the main square.
Location - the riad is located within about 8 mins walk from the main square. We were provided with a helpful map to direct us to the square.
The only redeeming part of this hotel is the roof terrace with views of the atlas mountain and Marrakech.
I will definitely avoid this hotel if ever I'm in Marrakech again
- Official Description (provided by the hotel):
- The riad has been lovingly restored over many years by its English owner and offers sumptuous accommodation over two floors each of the spacious five double bedrooms has reversible air conditioning with en-suite bathrooms and their chic but authentic styles are to be savoured. The inner courtyard is surrounded by tall elegant arches, refreshed by two flowing fountains and only the whisper of water and the song of the birds will come to disturb your tranquility. ... more less
- Reservation Options:
- TripAdvisor is proud to partner with Expedia, Booking.com, Priceline, Hotels.com, Travelocity, Orbitz and Hotwire so you can book your Riad Dar Eliane reservations with confidence. We help millions of travelers each month to find the perfect hotel for both vacation and business trips, always with the best discounts and special offers.
- Also Known As:
- Riad Dar Eliane Hotel Marrakech
- Dar Eliane Marrakech
- Dar Eliane Hotel Marrakech


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The Heat (Toni Braxton album)
|The Heat
|Studio album by Toni Braxton
|April 25, 2000
|Toni Braxton (also exec.), Keri Lewis, Babyface (also exec.), Daryl Simmons, Rodney Jerkins, Bryan-Michael Cox, David Foster, Keith Crouch, Teddy Bishop, Jazze Pha, Kevin Hicks
|Toni Braxton chronology
|Singles from The Heat
The Heat is the third studio album by American recording artist Toni Braxton. Released in the United States on April 25, 2000 by LaFace Records, the album marked Braxton's departure from her ballads in favor of a more urban sound. Most of the songs (including the nearly instrumental "The Art of Love") were written and produced by Braxton and her husband Keri Lewis (a former member of Mint Condition), two ballads were penned by Diane Warren, and collaborations featured rappers Dr. Dre and Lisa "Left Eye" Lopes.
The Heat opened at number two on the Billboard 200 chart selling 194,448 units in its first week. It was certified double platinum by the Recording Industry Association of America (RIAA) on October 13, 2000, with sales of over 2.2 million copies within the U.S. Additionally, the album was nominated for Best R&B Album at the 2001 Grammy Awards, while lead single "He Wasn't Man Enough" won for Best Female R&B Vocal Performance and was nominated for Best R&B Song.
Background and production[edit]
After the success of her sophomore studio album, Secrets (1996), which spawned Braxton's signature song and biggest hit of her career, "Un-Break My Heart", and sold over 15 million copies worldwide,[2] Braxton filed a suit to be released from her contract with Arista and LaFace records in Los Angeles Superior Court, citing a law that states employers may not enforce labor or service after seven years.[3] After a year of legal issues, Braxton settled her lawsuit with LaFace Records, with plans to release a new album in May 1999.[4]
In February 1999, Babyface told MTV News that, "We're getting ready head back in the studio with Toni and we've got everything worked out, and we're really excited about getting back into the studio, getting back to the music."[5] However, only in January 2000, during an interview with CNN.com, Toni revealed that the album was going to be released in March 2000, while stating, "Some of the producers on the album are, of course Babyface, R. Kelly, David Foster, Keith Crouch and Keri Lewis of Mint Condition, just to name a few," while also revealing collaborations with Lisa "Left Eye" Lopes from TLC and Dr. Dre.[6]
Music and lyrics[edit]
"The Heat" is built on solid ballads and smoldering, mid-tempo dance numbers, as noted by Allmusic's Stephen Thomas Erlewine.[1] Colin Ross of PopMatters noted that, "By taking a more active role in the writing and production of the set, Toni's material begins to be constructed around her voice rather than the latest producer's sound."[7]
The album's first single and opening track, "He Wasn't Man Enough", was written and produced by Rodney Jerkins. The R&B song, with synth-funk bassline and Jerkins' taut beats and harp,[8] has Toni warning a female friend not to marry a man the singer knows all too well[9] and that came back begging for forgiveness.[8] On the title track, "The Heat", co-written by Keri Lewis, was described as "an infectious mid-tempo groove."[7] Lyrically, the song talks about wanting to "get it on" and enjoying coed skinny-dipping.[10] Third track, "Spanish Guitar" ,was written by Diane Warren (who wrote "Un-Break My Heart") and was considered a "latin ballad", inspired by "Un-Break My Heart".[11] Lyrically, the song has the singer inviting an alluring stranger to play her "through the night" like a "Spanish Guitar."[10] The fourth track "Just Be a Man About It" is a telephone breakup song,[1] with Toni once again questioning the status of a partner's manhood[7] and Dr. Dre playing the wayward lover breaking the news to her,[1] while fifth track, "Gimme Some", features Lisa "Left Eye" Lopes and was named "an R&B/summer 'jerky funker' track",[7] with Braxton demanding intercourse and oral sex from a man.[10]
"I'm Still Breathing" is another song written by Diane Warren and talks about a woman stung by a painful breakup who summons strength,[10] while "Fairy Tale", co-written and produced by Babyface, is an "acoustic piece"[9] where the singer implies that being "just friends" may be healthier than a "love affair."[10] Pillow talk and ecstatic moaning characterize "The Art of Love,"[10] a track that features no discernible lyrics,[7] Braxton's sighs and moans[11] over undulating rhythms".[9] On "Speaking in Tongues," a "sensual affair" with warm harmonies,[7] spiritual expressions are co-opted and woven amid passionate propositions including, "Talk dirty to me."[10] The tenth track "Maybe" has rapid-fire lyrics, informed by hip-hop vocal rhythms and lyrically discuss the singer debating —in rapturous detail— whether or not to have drinks and sex again with her boyfriend ("Should I give him some/Will he make me hot/Will he hit the spot I love a lot", she sings).[10] The eleventh track "You've Been Wrong" was considered "plodding",[7] while the twelfth and final track, "Never Just For a Ring", finds Braxton questioning her lovers lack of fidelity the song features the embittered choral hook "Why?, when?, where?, how?, who?, what?", made you go off and do this crazy thing.[7]
Critical reception[edit]
|Professional ratings
|Review scores
|Entertainment Weekly
|Plugged In
|Rolling Stone
|The New Rolling Stone Album Guide
The album received a positive reception from most music critics. Stephen Thomas Erlewine from Allmusic gave the album four stars (out of possible five), writing that the album "is a confident, assured, sexy effort that reaffirms Braxton's status as one of the finest contemporary mainstream soul singers."[1] While praising the singles "He Wasn't Man Enough", "Spanish Guitar" and "Just Be a Man About It", he wrote that "The Heat slightly runs out of momentum toward the end, but there aren't many dull spots on the record -- it's all stylish, sultry, seductive, appealing urban contemporary soul that confirms Braxton's prodigious talents."[1] Jim Farber wrote a positive review for Entertainment Weekly, stating that the album is "tasteful, well-performed, and -- best of all -- consistent stuff, throwing the lovelorn a reliable lifeline."[9]
Collin Ross gave it seven stars (out of possible ten) and wrote for PopMatters that the album has "a mixed bag", but "despite being largely formulaic, The Heat offers some moments of quality."[7] He also hoped that "Keri Lewis/Braxton collaborative will play a more substantial role on her next album."[7] Barry Walters wrote a favorable review for Rolling Stone, saying that the album "updates and diversifies her stylistic surroundings while delivering the expected boudoir soundtrack."[11] He also wrote that "Braxton radiates sublimely sensual romance" on the album.[11]
Commercial performance[edit]
The Heat debuted at number 2 on the Billboard 200 chart, selling 194,448 units in its first week. It debuted at number-one on the magazine's R&B/Hip-Hop Albums chart, while the album's lead-single, "He Wasn't Man Enough", held onto the top spot on the R&B/Hip-Hop Songs chart for the second week in a row.[16] Later, the album fell to number 7, selling 101,000 copies.[17] In its third week, the album fell out to number 9.[18] The Heat was certified 2x Platinum by the Recording Industry Association of America, and as of April 11, 2011, the album has sold 2,093,000 copies in the U.S., according to Nielsen Soundscan figures.[19]
The album topped the Canadian Albums Chart, while it reached number 3 on the UK Albums Chart, staying 19 weeks on the UK charts.[20] The album also reached the top-ten in many countries, such as Austria, Belgium, France, Germany, Netherlands, Norway, Sweden and Switzerland.[21] As of 2002, the album had sold over 4 million copies worldwide.[22]
Awards and nominations[edit]
The Heat was nominated for many awards. At the 43rd Annual Grammy Awards, the album's lead-single, "He Wasn't Man Enough", was nominated for Best R&B Song and eventually won a Grammy Award for Best Female R&B Vocal Performance, while the album itself was nominated for Best R&B Album.[23] Braxton was also nominated for Best R&B/Soul album, Female on the Soul Train Music Awards,[23] but lost to Who Is Jill Scott? Words and Sounds Vol. 1" by Jill Scott. Braxton won two American Music Awards for Favorite Soul/R&B Female Artist and Favorite Soul/R&B Album (The Heat).[23]
The album's lead-single, "He Wasn't Man Enough", was released on March 11, 2000, with critical acclaim,[24] and won a Grammy Award for Best Female R&B Vocal Performance.[23] It was also a success on the charts, where it peaked at number 2 on the Billboard Hot 100 chart and topped the Hot R&B/Hip-Hop Singles & Tracks.[25] Elsewhere, it topped the Canadian Hot 100 chart, while reaching the top-ten in Australia, New Zealand, Netherlands, Sweden, Switzerland[26] and the United Kingdom.[27] The album's second single in the U.S. was the song "Just Be a Man About It". It reached number 36 on the Billboard Hot 100 and number 6 on the Hot R&B/Hip-Hop Singles & Tracks.[25]
Outside of the U. S., "Spanish Guitar" was released as the album's second single on September 19, 2000 (initially LaFace Records didn't release it as a single, due to the promotion of "Just Be a Man About It").[28] It achieved moderate success on the charts around the world, reaching the top-forty in Austria, Belgium, Netherlands and Switzerland.[29] In Brazil, the song was a huge success due to its inclusion on the soap opera "Laços de Família", reaching number 27 on the Brazil Hot 100 chart,[30] while in the U.S., when it was released as the album's third single, "Spanish Guitar" only managed to reach number 98 on the Billboard Hot 100, number 20 on the Adult Contemporary and topped the Dance Music/Club Play Singles.[25] The album's final single, "Maybe", achieved minor success on the R&B and dance charts,[25] due to the cancelled racy video.
Track listing[edit]
|"He Wasn't Man Enough"
|Rodney Jerkins, Fred Jerkins III, LaShawn Daniels, Harvey Mason, Jr.
|Rodney Jerkins
|"The Heat"
|Keri Lewis, Toni Braxton
|Keri Lewis, Toni Braxton
|"Spanish Guitar"
|Diane Warren
|David Foster
|"Just Be a Man About It"
|Toni Braxton, Johntá Austin, Teddy Bishop, Bryan-Michael Cox
|Bishop, Braxton, Bryan-Michael Cox
|"Gimme Some" (featuring Lisa "Left Eye" Lopes)
|Phalon Alexander, Toni Braxton, Babyface, Lisa Lopes
|Babyface, Jazze Pha
|"I'm Still Breathing"
|Diane Warren
|David Foster
|"Fairy Tale"
|Marc Harris, Tommy Sims, Babyface
|"The Art of Love"
|Toni Braxton, Keri Lewis
|Braxton, Lewis
|"Speaking in Tongues"
|Toni Braxton
|Braxton, Lewis
|Toni Braxton, Keith Crouch, Samuel Gause, Mechalie Jamison, John Smith
|Crouch, Braxton
|"You've Been Wrong"
|Toni Braxton, Brian Casey, Brandon Casey, Teddy Bishop, Kevin Hicks, Thom Bell, Linda Creed
|Bishop, Hicks
|"Never Just for a Ring"
|Daryl Simmons, Toni Braxton, Pure Soul
|Daryl Simmons
Total length:
Peak positions[edit]
Decade-end charts[edit]
|Preceded by
The W by Wu-Tang Clan
|Irish Albums Chart number-one album
December 23–30, 2000
|Succeeded by
Hot Shot by Shaggy
- ^ a b c d e f g h Erlewine, Stephen Thomas. The Heat - Toni Braxton at AllMusic. Retrieved 2011-10-17. Cite error: Invalid
<ref>tag; name "allmusic" defined multiple times with different content (see the help page).
- ^ Levine, Nick (2010-05-03). "Toni Braxton: 'Yesterday'". Digital Spy. Hachette Filipacchi Médias. Retrieved 2011-09-05.
- ^ "Toni Braxton In Contract Dispute". MTV News. August 12, 1998. Retrieved May 23, 2014.
- ^ "Toni Braxton Settles With LaFace Records, Starts Work On Album". MTV News. January 13, 1999. Retrieved May 23, 2014.
- ^ "Babyface To Head Into Studio With Toni Braxton For New Album". MTV News. February 18, 1999. Retrieved May 23, 2014.
- ^ "A chat with R&B singer Toni Braxton". CNN.com. January 31, 2000. Retrieved March 23, 2014.
- ^ a b c d e f g h i j k Ross, Colin. "Toni Braxton: The Heat". PopMatters. Retrieved 2011-10-17.
- ^ a b Dalton, Stephen (April 1, 2000). "NME Track Reviews - He Wasn't Man Enough". NME. Retrieved May 23, 2014.
- ^ a b c d e Farber, Jim (April 28, 2000). "The Heat Review". Entertainment Weekly. Retrieved 2011-10-17.
- ^ a b c d e f g h i "Toni Braxton - The Heat - Plugged In". Plugged In. Retrieved May 23, 2014. Cite error: Invalid
<ref>tag; name "pluggedin" defined multiple times with different content (see the help page).
- ^ a b c d e Walters, Barry (June 8, 2000). "Toni Braxton: The Heat : Music Reviews". Rolling Stone. Archived from the original on 2008-07-26. Retrieved 2011-10-17.
- ^ Tirella, Joseph V.; Linden, Amy; Foege, Alec (May 1, 2000). "Picks and Pans Review: The Heat". People. Retrieved 2013-04-08.
- ^ a b "Toni Braxton - Heat CD Album". CD Universe. Retrieved 2013-04-08.
- ^ [1]
- ^ Janssen, Aneta (April 24, 2000). "Reviews - Toni Braxton - The Heat". UKMIX. Retrieved 2013-04-08.
- ^ "Toni Braxton Tops R&B Albums, Singles Charts". MTV News. May 4, 2000. Retrieved May 24, 2014.
- ^ Jenison, David (May 17, 2000). "'N Sync Tops; Hanson Tanks". E! Online. Retrieved May 24, 2014.
- ^ "Nelly's Country Grammar Tops R&B/Hip-Hop Chart". MTV News. July 27, 2000. Retrieved May 24, 2014.
- ^ "Toni Braxton's decade-long record sales slump". Baltimore Sun. April 11, 2011. Retrieved May 24, 2014.
- ^ a b "Chart Stats – Toni Braxton – The Heat". The Official Charts Company. Chart Stats. Retrieved October 4, 2008.
- ^ a b c d e f g h i j k l m "Toni Braxton – The Heat". ARIA. Hung Medien. Retrieved November 1, 2010.
- ^ "Vibe Magazine". Vibe Magazine. Google Books. Retrieved May 24, 2014.
- ^ a b c d "Rock on the Net: Toni Braxton". Rock on the Net. Retrieved May 24, 2014.
- ^ "Billboard March 11, 2000". Billboard Magazine. Google Books. Retrieved May 24, 2014.
- ^ a b c d e f "The Heat - Toni Braxton - Awards". Allmusic. Retrieved May 24, 2014.
- ^ "Australian-Charts.com: He Wasn't Man Enough". ARIA Charts. hungmedien. Retrieved May 24, 2014.
- ^ "Chart Archive - Toni Braxton - He Wasn't Man Enough". Chart Archive. Retrieved May 24, 2014.
- ^ "Spanish Guitar #1 CD Toni Braxton". CD Universe. Retrieved May 24, 2014.
- ^ "Australian-Charts.com: Spanish Guitar". ARIA Charts. hungmedien. Retrieved May 24, 2014.
- ^ "Hot 100 Brasil (PDF)" (PDF). Hot 100 Brasil. Retrieved April 4, 2014.
- ^ "Musicline.de – Chartverfolgung – Toni Braxton – The Heat". Media Control (in German). PhonoNet GmbH. Retrieved October 4, 2008.
- ^ "Top 40 album- és válogatáslemez-lista – 2000. 19. hét". Mahasz (in Hungarian). Retrieved October 5, 2008.
- ^ "The Heat – Toni Braxton". Oricon (in Japanese). Retrieved July 24, 2009.
- ^ "ARIA Charts – Accreditations – 2000 Albums". Australian Recording Industry Association.
- ^ "Gold-/Platin-Datenbank (Toni Braxton; 'The Heat')" (in German). Bundesverband Musikindustrie.
- ^ "Brazilian album certifications – Toni Braxton – The Heat" (in Portuguese). Associação Brasileira dos Produtores de Discos.
- ^ "Dutch album certifications – Toni Braxton – The Heat" (in Dutch). Nederlandse Vereniging van Producenten en Importeurs van beeld- en geluidsdragers.
- ^ "The Official Swiss Charts and Music Community: Awards (Toni Braxton; 'The Heat')". IFPI Switzerland. Hung Medien.
- ^ "British album certifications – Toni Braxton – The Heat". British Phonographic Industry. Enter The Heat in the field Keywords. Select Title in the field Search by. Select album in the field By Format. Select Gold in the field By Award. Click Search
- ^ "American album certifications – Toni Braxton – The Heat". Recording Industry Association of America. If necessary, click Advanced, then click Format, then select Album, then click SEARCH
- ^ "Decade End Charts – R&B/Hip-Hop Albums". Billboard. Nielsen Business Media, Inc. Retrieved November 1, 2010.


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Link returns to Hyrule to search for the Triforce and to awaken Zelda from an endless sleep. Embark on a quest to find the Triforce of Courage and save Hyrule from ruin. Learn magic spells, talk to people in towns to get clues, collect items to increase your power and explore six palaces where the underlings of the evil Ganon await you. This sequel to the Adventure classic uses a side-scrolling visual engine unique to the series for more technical combat, and features more in-depth world roaming as Link encounters townsfolk while on his quest.
This classic game is part of the Virtual Console service, which brings you great games created for consoles such as NES™, Super NES™ and Game Boy™ Advance. See more Virtual Console games for Wii.


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Community Ties
Union Pacific Helps Celebrate College Station's 75th Birthday
Posted November 20, 2013 10:56 AM CDT
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UP's goodwill ambassador, the Mini-train, gave free rides outside the George Bush Presidential Library and Museum throughout the day Nov. 16 as part of College Station's 75th anniversary celebration.
The City of College Station, Texas, marked the 75th anniversary of its incorporation Nov. 16 with a community celebration sponsored by Union Pacific at the George Bush Presidential Library and Museum.
College Station and UP share a rich heritage dating back to the founding of the Agricultural and Mechanical College of Texas (Texas A&M College) in 1876. The site for the new college was selected in large part because of the existence of a Houston and Texas Central (H&TC) Railroad line, which began in Southeast Texas and extended through the area to its terminus in Bryan, five miles north. Although no railroad depot existed at the time of Texas A&M's formal opening, H&TC made regular stops for incoming and outgoing college students and faculty. H&TC railroad conductor announced the stop as "College Station," giving rise to the name of the surrounding community. Although passenger rail service ceased in 1959, College Station and the railroad, now Union Pacific, have continued to grow together.
To commemorate their heritage, UP's J.M. Carreon, AVP-Public Affairs, presented College Station Mayor Nancy Berry with a Train Town U.S.A. certificate and plaque. UP locomotive engineers Anthony Jacquet and Aundrea White, along with Stuart Schroeder, train dispatcher from the Spring Dispatching Center, presented information on railroad safety.
UP's goodwill ambassador, the Mini-train, offered free ride throughout the day to the more than 1,000 on hand for the celebration.
UP's J.M. Carreon, AVP-Public Affairs, presents College Station Mayor Nancy Berry with a Train Town U.S.A. certificate and plaque.
UP locomotive engineer Aundrea White, second from left, and Stuart Schroeder, train dispatcher from the Spring Dispatching Center, center, are joined by the Aggie Wranglers at the UP safety information booth.
Texas A&M mascott Reveille VIII gets a pet by UP dispatcher Stuart Schroeder.
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Tim Price paraphrases Mark Twain, declaring that "reports of cotton's death are greatly exaggerated."
In a year when he says talk has gone from 'What kind of cotton year do you think this will be?' to 'Will we even have cotton in years to come?', the Southern Cotton Ginners Association executive vice president says the industry has been hit with "a cold reality check" in this year when corn has knocked off king cotton's crown in terms of acres planted in the Delta.
But he said at the association's joint meeting with the Delta Council's Ginning and Cotton Quality Improvement Committee at Stoneville, Miss., "Our industry is always changing, and the question becomes, how can we affect the inevitable to our own benefit? How we answer that is critical to our future success.
"I believe we will not only have a future for cotton, but that the cotton industry is the model for commodities in the future. It's the most highly technically attached to developments in seed genetics, global positioning systems technology, and other cutting edge advancements. It also has a value-added component in our cotton gins that produce industrialized products."
There is, Price says, "intense investment and continued major interest worldwide in the manufacturing and equipment sector in the harvesting and ginning of cotton, so they obviously believe in its future and sustainability.
"What we have in our industry, and the infrastructure we have, haven't come by accident or by history, but by continual advancements in technology and finding ways to develop even more useful, profitable products.
"Thanks to organizations like the National Cotton Council, the Delta Council, and other Mid-South ag organizations, plus a strong agricultural research system, we've been able to work together to bring even more advancements to our industry."
Price says the SGA is currently working with the National Cotton Ginners Association and the National Cotton Council to develop a contract for sales of cottonseed and other products that will be suited to the industry's particular needs.
"With concerns over food safety and food security, what happened with contaminated pet foods and other issues related to China that came home to the American consumer and American industry, we're taking a proactive step that will help us say to our customers, 'Here is the quality I'm guaranteeing in a contract, and I'm testing it before I send it to you.'
"It's a lot better, for example, that we test for aflatoxin before we send a shipment into export than to have the customer come back later and say, 'Guess what I found?' The days of working with a generic contract form and a handshake are gone, and this will increase our reliability and viability for the future."
The ginner association has also placed major emphasis on safety and has developed a program that keeps management and workers continually involved in training and awareness efforts — which has not only drastically cut worker injuries and deaths, but has had a significant impact on insurance costs and insurability.
"It's far better to have this sort of thing come from within than to have the government do it for you."
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High on a granite cliff in South Dakota's Black Hills tower the huge carved faces of four American presidents: George Washington, Thomas Jefferson, Abraham Lincoln, and Theodore Roosevelt. Together they constitute one of the world's largest pieces of sculpture.
The story of Mount Rushmore's creation is as bizarre and wonderful as the monument itself. It is the tale of a hyperactive, temperamental artist whose talent and determination propelled the project, even as his ego and obsession threatened to tear it apart. It is the story of hucksterism and hyperbole, of a massive public works project in the midst of an economic depression. And it is the story of dozens of ordinary Americans who suddenly found themselves suspended high on a cliff face with drills and hammers as a Danish sculptor they considered insane directed them in the creation what some would call a monstrosity, and others a masterpiece.
John Wesley Powell's epic journey into the unknown Grand Canyon was filled with adventure as his team mapped the Colorado River for the first time.
In 1927, the Mississippi River flooded from New Orleans to Illinois, leaving a million people homeless and leading to a major black migration to the North.
The coal miners' battle for dignity led to the largest armed insurrection since the American Civil War.
The inspiring story of the modern environmental movement.
Today one of the most-recognized figures in American literary history, poet Walt Whitman was denounced by critics in his own time.
A daunting story of shipwreck, starvation, mutiny and cannibalism amongst a group left abandoned in the high Arctic.
When an earthen dam broke without warning, a small city in Pennsylvania was swept away in a wall of water over 30 feet high.
Native Alaskans, oil company representatives, environmentalists, politicians, and others tell the story of the 800-mile pipeline.


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Houses to let in Peel Street, Adlington, Chorley PR6
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Railway Road, Adlington, Chorley PR6Property to rent - 2 bedrooms
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Brook Street, Adlington, Chorley PR6Cottage to rent - 2 bedrooms
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In Clint Eastwood's new film, "J. Edgar," a 1930 movie theater audience makes its preference clear. Whereas J. Edgar Hoover's pre-movie promotion reel about G-men and the FBI draws impatient boos, a trailer for the upcoming James Cagney flick "The Public Enemy" inspires hoots and applause.
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