The Food and Drug Administration (FDA) has issued a warning letter to Alkermes, the manufacturer of Vivitrol (naltrexone extended-release injection), for omitting serious warnings and precautions from print advertisements promoting the treatment.
Vivitrol, an opioid antagonist, is approved for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol. It is also indicated for the prevention of relapse to opioid dependence, following opioid detoxification; treatment should be part of a comprehensive management program that includes psychosocial support.
While claims about the benefits of Vivitrol were clearly presented in the ad, serious risks, such as vulnerability to opioid overdose, were not communicated. The prescribing information states that after opioid detoxification, patients are likely to have reduced tolerance to opioids. Specifically, the labeling includes the following warnings and precautions that were omitted in the promotional materials:
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. Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment.
There is also the possibility that a patient who is treated with Vivitrol could overcome the opioid blockade effect of Vivitrol. Any attempt by a patient to overcome the antagonism by taking opioids is especially dangerous and may lead to life-threatening opioid intoxication or fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade.
In addition to these serious warnings, the ad omits language regarding common treatment-emergent adverse effects such as injection site reactions, muscle cramps, dizziness, syncope, somnolence, sedation, anorexia, decreased appetite or other appetite disorders.
“Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner,” said Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion in the FDA’s Center for Drug Evaluation and Research. “This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”
The Office of Prescription Drug Promotion (OPDP) is responsible for reviewing prescription drug advertising and promotional labeling to ensure that the information presented is not false or misleading. In addition, the FDA-sponsored Bad Ad Program was designed to increase the effectiveness of the OPDP’s surveillance program by educating healthcare professionals about misleading promotion and providing an easy way to report it.
In the warning letter, the FDA stated that Alkermes must stop using the promotional materials that omit the potential consequences of Vivitrol use. In addition, the Company will need to provide the Agency with a plan for disseminating accurate information addressing the issues outlined in the letter.
Healthcare professionals can report potentially false or misleading advertising to the FDA by emailing [email protected] or calling (855) RX-BADAD.
For more information visit fda.gov.