The U.S. Food and Drug Administration (FDA) recently issued a warning letter to Alkermes, Inc. due to misbranding on the drug Vivitrol, which is used to prevent opioid dependence relapse. The letter was issued because promotional materials didn’t including warnings about risks associated with the treatment, specifically a lack of language about the “vulnerability to opioid overdose.”
The FDA’s director of Office Prescription Drug Promotion, Thomas Abrams, describes the warning letter as follows: “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…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.”
The FDA encourages healthcare providers to report any adverse events or misleading advertising to the FDA’s MedWatch Adverse Event Reporting program and to its Bad Ad Program. These programs are designed to help promote patient safety, and should be top of mind for all healthcare providers.
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