FDA Policy/General

Vivitrol Ad Omits Risk Information: OPDP

The CDER Office of Prescription Drug Promotion (OPDP) says an Alkermes print ad for Vivitrol (naltrexone for extended-release injectable suspension) for intramuscular use is false and misleading because it omits important risk information associated with using the drug. A 12/2 Warning Letter says the violation “is concerning from a public health perspective because it creates a misleading impression regarding the overall safety of Vivitrol. Opioid dependence and misuse is a significant public health concern and a national crisis that impacts millions of lives in the U.S. When used as provided in the FDA-approved product labeling, Vivitrol is safe and effective for the prevention of relapse to opioid dependence, following opioid detoxification. However, those using Vivitrol for the treatment of opioid dependence should be made aware of the vulnerability to a potentially fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing Vivitrol treatment.”

The OPDP letter says the ad contains claims and representations about Vivitrol benefits but fails to communicate information from the labeling Warnings and Precautions section concerning vulnerability to opioid overdose, a potentially fatal risk. “OPDP is concerned that Alkermes continues to promote Vivitrol in a manner than fails to adequately present this important risk information in a truthful and non-misleading manner,” the letter says.

Alkermes was told to stop misbranding Vivitrol and/or stop introducing the misbranded drug into interstate commerce. It was told to respond with a list of all promotional materials containing violative statements and a plan to discontinue their use or a plan to stop distributing Vivitrol. The company also is to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to the audiences that received violative promotional materials.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome