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Regulatory Focus™ > News Articles > 2019 > 12 > FDA Warns Alkermes for Misleading Print Ad

FDA Warns Alkermes for Misleading Print Ad

Posted 11 December 2019 | By Zachary Brennan 

FDA Warns Alkermes for Misleading Print Ad

The FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter last Monday to Alkermes for distributing a print advertisement for its alcohol- and opioid-dependence treatment Vivitrol (naltrexone for extended-release injectable suspension) that omitted risk information.

This is the 10th warning or untitled letter issued by OPDP, which is the highest number of letters issued by the office since 2016.

OPDP said the Vivitrol print ad contains claims and representations about the benefits of the treatment but it fails to communicate information from the warnings and precautions section of the product labeling “concerning vulnerability to opioid overdose, a potentially fatal risk.”

“Vivitrol blocks the effects of exogenous opioids for approximately 28 days after administration. However, as the blockade wanes and eventually dissipates completely, patients who have been treated with Vivitrol may respond to lower doses of opioids than previously used, just as they would have shortly after completing detoxification. This could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.) if the patient uses previously tolerated doses of opioids,” the letter notes.

OPDP said it’s concerned that Alkermes continues to promote Vivitrol in a manner that fails to adequately present risk information in a truthful and non-misleading manner.

In response to the warning letter, FDA is seeking by next Monday information from Alkermes on whether it intends to comply with FDA’s request, which would include listing promotional materials for Vivitrol that contain misleading statements and a plan for discontinuing use of such materials, or for ceasing distribution of Vivitrol.

An Alkermes spokesperson told Focus: “At Alkermes, we are dedicated to patient safety and the appropriate use of our medicines, and we recognize the importance of accurately communicating the benefits and risks of our medications. We take this matter very seriously and are committed to working closely with the FDA to ensure that all of our promotional materials are fully compliant with applicable laws and regulations.”

Warning Letter
 

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