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Blog 4 - PRNewswire Article

FDA issues warning letter to drug company Alkermes, Inc. over failing to identify all the risks of its drug Vivitrol in an advertisement

The Food and Drug Administration has issued a warning letter to Alkermes, Inc. for misbranding its drug Vivitrol by omitting warnings about the most serious risks of the drug from promotional materials. Vivitrol is approved for treatment of opioid dependence by preventing relapse following opioid detoxification. The FDA issued the warning letter because of a print advertisement for Vivitrol. While the advertisement goes over the benefits of Vivitrol, it failed to adequately communicate the precautions and risks that the drug may possess. The most serious being a potentially fatal vulnerability to opioid overdose. "One way the FDA protects the public health is by ensuring that prescription drug information disseminated by drug sponsors is truthful, balanced and accurately communicated. We do this by reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading," said Thomas Abrams, director of the FDA's Office of Prescription Drug Promotion in the FDA's Center for Drug Evaluation and Research. "Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner. This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population." Because of this, the FDA is requesting that Alkermes, Inc. immediately cease anything that mislabels the product. It also requested that the company implement a comprehensive plan of action for making sure that anyone that received the mislabeled promotional materials are adequately informed of all the truthful, complete information. Specifically the materials fail to communicate that patients being treated by Vivitrol may experience reduced tolerance to opioids after taking Vivitrol. The drug works by blocking the effects of opioids, and the drug’s effect lasts 28 days. As the effect wanes and eventually clears, and if patients are taking opioids as this clearing is occuring, it may lead to patients responding to lower doses of opioids than they did before. Thus if they then take an opioid in the same dosage they used before Vivitrol, it may lead to an overdose. There is also a possibility that someone taking Vivitrol may overcome the drug’s effect blocking opioids. The materials also fail to address a few other risks including injection site reactions, and other common adverse reactions. The FDA has also requested that Alkermes, Inc. issues a written response to their warning letter by Dec. 16th.