Recently, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Alkermes, Inc. for distributing a print advertisement for Vivitrol (an extended-release injection formulation of naltrexone, alcohol and opioid-dependence treatment) that did not include risk information.
According to OPDP, the Vivitrol print ad in question includes claims and representations about the benefits of the treatment but leaves out any information from the warnings and precautions section of the product labeling, especially “concerning vulnerability to opioid overdose, a potentially fatal risk.”
According to the letter, “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 warning letter makes note of two other times the FDA previously reached out to Alkermes on the issue. After noting those two previous contacts, the letter says the “OPDP is concerned that Alkermes continues to promote Vivitrol in a manner that fails to adequately present this important risk information in a truthful and non-misleading manner.” It is perhaps for these reasons that the FDA issued a warning letter instead of an untitled letter.
FDA took a step further than normal and issued a press release announcing the violations and the warning letter. “Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner,” OPDP director Thomas Abrams said in the announcement. “This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”
Due to the seriousness of the violation, the FDA is not only requesting the company immediately cease advertising practices that misbrand Vivitrol but also that the company create a comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.
Alkermes Response
In response to the OPDP letter, Alkermes released a statement, noting the company’s dedication to “patient safety and the appropriate use of our medicines,” and acknowledging the importance “of accurately communicating the benefits and risks of our medications.”
Alkermes continues, stating that the “FDA Warning Letter relates to a Journal Advertisement, not currently in use, which was accompanied by a Brief Summary of Prescribing Information for VIVITROL® (naltrexone for extended-release injectable suspension). In the Warning Letter, the FDA states that certain of the important safety information contained in the Brief Summary should have been in the body of the Journal Advertisement itself.”
In closing, Alkermes iterated its commitment to working closely with the FDA to ensure all promotional materials are “fully compliant with applicable laws and regulations.”
Following the Alkermes statement was important safety information about Vivitrol, including indications, contraindications, warnings and precautions (including vulnerability to opioid overdose, hepatotoxicity, and depression/suicidal ideations), and adverse reactions.