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Sterol and sterolin-containing products: hematologic adverse reactions.

This quarterly publication alerts health professionals to potential signals detected through the review of case reports submitted to Health Canada. It is a useful mechanism to disseminate information on suspected adverse reactions to health products occurring in humans before comprehensive risk–benefit evaluations and regulatory decisions are undertaken. The continuous evaluation of health product safety profiles depends on the quality of your reports. Although not approved by Health Canada, sterol and sterolin-containing products are used by some primarily for their presumed immune-enhancing properties. Plant sterols (phytosterols) are structurally related to cholesterol and perform the same functions in plant membranes as does cholesterol in animal membranes. The main phytosterols derived from the diet include -sitosterol, campesterol and stigmasterol, all of which are unsaturated. Sterolins are glucosides of sterols. In humans, the absorption of phytosterols is low (5% or less of ingested sitosterol); however, people who have the rare inherited lipid storage condition known as phytosterolemia or sitosterolemia can absorb up to 63% of an ingested dose of sitosterol. Cholestasis and blood dyscrasias, including thrombocytopenia and hemolytic anemia, have been noted in adults and children receiving phytosterol-containing lipid emulsions with parenteral nutrition. The thrombocytopenia associated with parenteral nutrition is similar to that observed in cases of phytosterolemia with increased peripheral destruction of platelets. Reduced intake of such emulsions leads to decreased plasma phytosterol levels and subsequent alleviation of hepatic and platelet effects in some patients. A search of the Health Canada adverse reaction database revealed 4 reports in which sterol and sterolincontaining products were suspected of being associated with hematologic adverse reactions. Case 1: After 2–3 weeks of taking “Moducare Sterinol” (1 capsule per day) a 22-year-old man experienced a life-threatening hemolytic anemia requiring admission to hospital and treatment with steroids, intravenous immune globulin therapy and a blood transfusion. At the time of the adverse reaction, the patient was not taking any concomitant medications; however, he had a history of severe idiopathic thrombocytopenic purpura (ITP) and splenectomy. Upon discontinuation of the product, the reaction slowly resolved. Case 2: A 76-year-old man with a history of atrial fibrillation was taking Coumadin and had a stable international normalized ratio (INR) of 2.3–2.5. After an unknown interval of taking “Sterinol” (1 capsule per day), his INR fell to 1.6. Two weeks after discontinuing the Sterinol, his INR increased to 3.4. The patient began taking the Sterinol again, on a less frequent interval (1 capsule every 2 days), and his INR decreased to 2.0. Case 3: A 75-year-old woman had been taking “Moducare” (1 capsule 3 times daily) for about 2 months when In this Issue