Pharma Company Failed To Convey Overdose Risk Linked To Its Opioid Addiction Treatment, FDA Says
Vivitrol, manufactured by Alkermes, is meant to help those recovering for addiction, but it also lowers tolerance to opioids. That means if patients relapse while taking it they are far more vulnerable to overdoses.
The Washington Post:
FDA Warns Company Over Ad That Leaves Out Information On Risk Of Overdose
The Food and Drug Administration has warned the manufacturer of a long-acting anti-addiction medication that its printed advertisement does not include one of the most serious risks of using the product: the increased chance of an opioid overdose. In a Dec. 2 letter to Alkermes that was posted to the FDA’s website Wednesday, the agency said a company ad for Vivitrol does not warn users that they are more vulnerable to a “potentially fatal” overdose if they resume use of opioids after the medication wears off. (Bernstein, 12/11)
Stat:
FDA Blasts Alkermes For Underselling Risks Of Vivitrol
The company failed to sufficiently communicate the risk of overdose associated with Vivitrol, which is one of three FDA-approved medications used to treat opioid use disorder. While Vivitrol guards against opioid cravings and relapse for people in recovery from opioid addiction, it reduces opioid tolerance and leaves its users more vulnerable to opioid overdose for patients who relapse, even at comparatively low doses. (Facher, 12/11)
In other news on the opioid crisis —
San Francisco Chronicle:
New Online Tracking System Shows How Many SF Addiction Treatment Beds Sit Empty
San Francisco is hoping to better match the swelling population of those struggling with addiction to its vacant drug treatment beds. The Department of Public Health launched a new tool this month, findtreatmentsf.org, to track empty treatment beds in San Francisco after officials realized that desperately needed spots were sitting unused despite a tsunami of need on the streets. (Thadani, 12/11)
