The U.S. Food and Drug Administration issued a warning letter to the company for misbranding its opioid addiction medication Vivitrol in promotional materials.
Shares of Alkermes dropped nearly 3% Wednesday after the U.S. Food and Drug Administration (FDA) issued a warning letter to the company for misbranding its opioid addiction medication Vivitrol in promotional materials.
Vivitrol was approved by the FDA in 2008 for the prevention of relapse to opioid dependence, following opioid detoxification. The FDA said the company omitted warnings about the most serious risks from the medication in its promotional materials. The warning letter was issued in relation to a print advertisement about Vivitrol. While the print advertisement contains claims and representations about the drug’s benefits, it fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk, the FDA said in its announcement.
Specifically, the FDA said the warning label for Vivitrol notes that following opioid detoxification, patients are likely to have reduced tolerance to opioids. Vivitrol is designed to block the effect of an opioid. As the effect wanes and dissipates, patients who have been treated with Vivitrol may respond to lower doses of opioids than previously used, the regulatory agency said. If a patient uses opioids at the same dose they previously used following treatment with Vivitrol, it could result in an opioid overdose. The FDA said the print advertisement also omitted important warnings and precautions including the risk of injection site reactions and other common adverse reactions associated with the use of the drug.
Thomas Abrams, head of the FDA’s Office of Prescription Drug Promotion in the FDA’s Center for Drug Evaluation and Research said the FDA must ensure that prescription drug information provided to “drug sponsors” is “truthful, balanced and accurately communicated.” Abrams said the FDA reviews prescription drug advertising and promotional labeling to make sure the information is accurate and not 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,” Abrams said in a statement.
The FDA said it has demanded Alkermes cease any advertising practices that misbrand Vivitrol. Also, because the violations described in the warning letter have been deemed “serious,” the FDA said it is requesting that the company include a comprehensive plan of action to correct the matter and ensure it does not happen again.
In response to the warning letter, Alkermes said the FDA is raising a concern about an advertisement that is no longer in use. That advertisement was accompanied by a summary of important safety information related to Vivitrol, the company added. The company noted that the FDA said that warning information should have been contained in the body of the ad as opposed to a separate piece. Alkermes said it is finalizing its response to the FDA and is committed to ensuring all of its promotional materials are “fully compliant with applicable laws and regulations.”
