FDA slaps down Alkermes for misleading Vivitrol ads — don't forget vulnerability to opioid overdose
The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”
Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.
Now a new Vivitrol advertising campaign has prompted a stern warning from the FDA. The FDA said that Alkermes mentioned the possible benefits of the drug but failed to disclose major risks. Those include an increased likelihood that a patient will later overdose on opioids.
“This violation is concerning from a public health perspective because it creates a misleading impression regarding the overall safety of Vivitrol,” the FDA’s Center for Drug Evaluation and Research wrote in a warning letter to Alkermes CEO Richard Pops.
The letter says that the drug, when used properly, can help prevent relapse to opioid dependence — a significant public health concern. But “those utilizing Vivitrol for the treatment of opioid dependence should be made aware of the vulnerability to potentially fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing Vivitrol treatment,”
“Attempts to overcome blockade may also lead to fatal overdose,” it adds.
It’s not clear where the ad appeared, but it is targeted towards those working in the criminal justice system and directs them to Vivitrolcj.com. It shows a judge and a bald man in a sweatshirt exchanging a slim stack of papers over her bench.
“The criminal justice system is challenged with responding to the opioid epidemic,” it reads. “Their path to recovery can begin with your help,”
Under “important safety information,” it lists what Vivitrol is indicated for and indicated against, but it does not mention the fatal risk the drug poses.
Vivitrol, which is scientifically known as naltrexone for extended-release injectable suspension, blocks the effects of opioids from outside the body for around 28 days. But as that blockade weakens and ultimately vanishes, patients can respond to lower doses of opioids than they otherwise would.
A patient who takes a dose of opioids they previously would have tolerated could then overdose. Patients that try to overcome the block while the drug is in effect may also overdose.
There is less data out on Vivitrol than on other opioid dependency drugs buprenorphine and methadone, but in 2018 a paper in Drug Safety attempted to analyze the risk of overdose.
Out of 263 adverse events from Vivitrol that researchers obtained through a public records request, they were left with 52 deaths that fit an overdose description. Of those, 5 occurred in the 28 days, meaning the patient had tried to overcome the block. The median time of death was 46 days after injection and the average was 56.3 days — or a few weeks after the last shot’s blocking effects wore off.
Alkermes strongly disputed the results. The authors stopped short of announcing causality, but they said companies and the government need to follow the issue more closely and warn patients better, as at least around half will discontinue treatment.
“We’re saying that if you’re going to be putting people on it, there’s a time period after you take them off of it or they come off it where you need to do a better job of reminding them of their risk,” Nabarun Dasgupta, study co-author and a research scientist at the University of North Carolina, told ProPublica last year.