FDA WARNING_LETTER - Alkermes, Inc. - December 02, 2019

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Alkermes, Inc. regarding a print advertisement (VIV-003460-v2) for Vivitrol (naltrexone for extended-release injectable suspension). The print ad is deemed false or misleading because it omits crucial risk information, specifically regarding the vulnerability to potentially fatal opioid overdose. This misbrands Vivitrol under 21 U.S.C. 352(n), 321(n), and 331(a), and 21 CFR 202.1(e)(5), creating a misleading impression of the drug's safety, which is concerning given the opioid crisis.

The omitted risks include the potential for fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing Vivitrol, as patients' opioid tolerance is reduced post-detoxification. The ad also fails to mention the serious consequences of attempting to overcome Vivitrol's opioid blockade. Additionally, it omits other important warnings like injection site reactions (part of the Vivitrol REMS) and common adverse reactions. A small print statement referring to a brief summary does not mitigate these omissions.

OPDP noted prior communications, including a March 9, 2011 advisory letter and an October 12, 2018 information request from the Division of