{'fraction_non_alphanumeric': 0.04403131115459882, 'fraction_numerical': 0.02446183953033268, 'mean_word_length': 4.879310344827586, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Risk of intracranial hypertension with intrauterine levonorgestrel: reply

http://taw.sagepub.com 1 Dr Friedman raises some questions about our study (Etminan et al. 2015). She claims that the search term cerebral edema used in the disproportionality analysis should not have been used. Disproportionality analysis using the FDA’s FAERS database is intended to demonstrate whether there is a strong signal for a specific adverse event secondary to a drug that warrants further investigation. This type of analysis is used routinely by the FDA to issue warnings on specific safety concerns with prescription drugs (FDA.gov). Although cerebral edema was used as a search term in our study, the majority of events were cases of benign intracranial hypertension (BIH). In fact, when restricting the analysis to only cases of ‘benign intracranial hypertension’ in women with MirenaTM in FAERS using OpenVigil (2.1) (Böhm et al. 2012), the disproportionality odds ratio (OR) was still 3.4 (95% CI: 2.59–4.45) (Böhm et al. 2012).