February 10, 2020
More Bad News For Vivitrol
By Michael D. Shaw
Seven weeks ago, we ran a story on this drug, used in addiction treatment, including its problems with the FDA. On December 2, 2019, the agency issued a Warning Letter stating that a print ad for Vivitrol was false or misleading because it omitted important risk information.
Alkermes—manufacturer of the drug—failed to sufficiently communicate the risk of overdose, owing to the reduction of opioid tolerance, and leaves its users more vulnerable to opioid overdose for patients who relapse, even at comparatively low doses.
This vulnerability is inherent since Vivitrol (Naltrexone) is an opioid antagonist which binds to opioid receptors with higher affinity than agonists, but does not activate the receptors. Thus, it is non-addictive, and prevents any opioid from having an effect on the patient. Notably, with the effect of opioids being blocked, there is a very real danger of overdose, should a patient backslide and consume their opioid of choice. As such, it must only be used on a patient who has first been detoxed. A recent case confirms this.
As the previous article discussed, the non-addictive nature of Vivitrol, when compared to the other opioid addiction treatment drugs—methadone (full opioid agonist) and buprenorphine (partial opioid agonist)—appealed to those who foolishly bought into the polemic of “not substituting one addictive drug for another.” Not surprisingly, this attitude was far more common in the criminal justice system, than among physicians. And, Vivitrol has been mandated in certain jurisdictions.
Advocates of methadone and buprenorphine practice harm reduction, in that these drugs reduce HIV risk, improve family function, increase employment, and reduce the risk of heroin overdose. Dosing is carefully controlled, and in the case of methadone, only daily doses are dispensed.
Now, the danger of overdose for patients treated with Vivitrol is embodied in a wrongful death lawsuit against Alkermes, filed in the Superior Court of California in the County of Los Angeles. The action was filed on behalf of 26-year-old California resident Clayton Stafford, relating to his mandated two-year-long use of the drug, that led to a “tragic and preventable” opioid overdose in February, 2018.
According to Lieff Cabraser partner Fabrice N. Vincent, who filed the lawsuit on behalf of the Stafford family, “Clayton Stafford’s tragic death could have been avoided. The well-reported defects in Vivitrol made Clayton’s overdose a near-foregone conclusion, and had the Staffords received accurate information about Vivitrol’s risks and effective deficiencies from Alkermes, they would never had consented to its use by Clayton.”
The complaint echoes our first article noting that Vivitrol only blocks the brain’s opioid receptors without treating the brain’s needs. Thus, patients’ cravings for opioids remain, so patients are not weaned off their drug addiction…
“At the end of a Vivitrol cycle, a patient’s opioid tolerance is highly diminished, which leads to a greatly heightened chance of overdose. Further, because Vivitrol blocks the body’s natural endorphins from attaching to the brain’s receptors, the patient remains in a mentally deficient state and more likely to seek external drugs for relief. Because the patient’s addiction is not adequately treated, the patient requires indefinite Vivitrol use to merely block the euphoric effects and keep the patient from seeking opiates. Patients therefore remain highly likely to relapse despite indefinite use of Vivitrol.”
The complaint states that prior to the marketing of Vivitrol, Alkermes never conducted a comparison study versus methadone and buprenorphine. And, no independent studies were ever conducted comparing these treatments during this time period. “Despite lacking any scientific basis for promoting Vivitrol over methadone and buprenorphine, defendants engaged in a calculated campaign to mislead the policymaker community, including drug courts, legislators, and law enforcement, into believing that Vivitrol was more effective than the other treatments because it contains no opioids.”
It’s not too often that a drug is touted to the criminal justice system instead of the medical community. But, Alkermes proved that such a marketing plan works…until now.
The litigation includes claims for wrongful death, design defects, negligence, strict liability, failure to warn, and fraud and deceit, among other claims, and seeks wrongful death damages, survival damages, economic damages, and punitive damages, along with such other relief as the court may deem just and proper.
One more example of the grim observation that everything in healthcare is a fad.