安 全 警 示 及 藥 物 回 收 > 其 他 安 全 警 示

其 他 安 全 警 示   The United States: FDA orders important safety labeling changes for Addyi (flibanserin) (English Only)   The US Food and Drug Administration (FDA) announces that it issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the drug. The changes are the result of the FDA’s review of postmarketing studies, including one required of Sprout when Addyi was approved in Aug 2015, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, as well as other data. At the time of approval, the FDA reviewed data that included several concerning cases of severe hypotension (low blood pressure) and syncope (passing out) when Addyi and alcohol were taken together. As a result, Addyi’s labeling currently includes a boxed warning (the strongest warning the FDA requires), which states that alcohol must be avoided in women treated with Addyi. The FDA also required a risk evaluation and mitigation strategy (REMS), which requires that health care professionals who prescribe Addyi and pharmacies that dispense Addyi, must be certified with the Addyi REMS program and that patients must be counseled about the risk of hypotension and syncope. In addition, the FDA required Sprout to further study the interaction between Addyi and alcohol after approval. Based on the results of postmarketing studies, the FDA has determined that changes must be made to Addyi’s labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely. Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime. The FDA is ordering a safety labeling change requiring Sprout to make these changes because the agency was not able to reach an agreement with the company, which was continuing to request removal of the boxed warning and contraindication about alcohol completely from the product labeling. The FDA determined, based on a careful review of available data, that removing this important safety information was not acceptable for the protection of public health. The FDA’s decision to order modifications to the warnings about Addyi and alcohol, instead of removing the boxed warning and contraindication completely, is based on two sets of postmarket research studies. In the FDA-required postmarketing trial in women who took Addyi and drank alcohol at the same time, there were missing or delayed measurements for blood pressure from when the women were first laying down to when they stood up that are critical in determining the risk of hypotension and syncope when taking Addyi and alcohol together. The pattern of the missing or delayed measurements provides further evidence of an interaction between Addyi and alcohol that can increase the risk of hypotension and syncope. Given these results, the FDA has determined that the boxed warning and contraindication continue to be warranted. Women at home will not have the safety measures that were included in this trial or necessarily have access to immediate assistance if they were to experience severe hypotension or syncope, which can lead to serious outcomes including falls, accidents and bodily harm. In other postmarketing trials, results showed that the risk of severe hypotension and syncope was reduced when women who consumed up to two alcoholic drinks waited at least two hours before taking Addyi. The FDA has found these results sufficient to support a modification to the boxed warning and contraindication stating that Addyi and alcohol must not be taken close in time (i.e. not within two hours). Please refer to the following website in FDA for details: http://www.fda.gov/NewsEvents/Newsroom/../ucm635847.htm In Hong Kong, the above product is not a registered pharmaceutical product. Ends/Friday, Apr 12, 2019 Issued at HKT 16:00