FDA issues warning letter to Vivitrol manufacturer

~ Jason Schwartz

The FDA issued a warning letter today to the manufacturer of Vivitrol for “for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials.”

Here’s the salient portion of the letter.

. . . the print ad fails to communicate information from the WARNINGS AND PRECAUTIONS section of the PI concerning vulnerability to opioid overdose, a potentially fatal risk. Specifically, the PI states that after opioid detoxification, patients are likely to have reduced tolerance to opioids. 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.

I agree that discussion of the risks associated with relapse in the context of lowered tolerance is critical to meaningful informed consent.

I’m also a believer that drug companies cannot be trusted to put the needs of patients ahead of profits. Therefore, I welcome the FDA’s intervention in cases like this.

All that said, it’s worth taking a step back and thinking about the context of this warning.

Tolerance is a diagnostic criterion for opioid use disorder or addiction. It could also be discussed as a symptom.

Is there any other illness where elimination of a symptom is treated as undesirable?

Loss of tolerance can be dangerous, even deadly, in many contexts. AND, loss of tolerance (abstinence) can be an indicator of healing, wellness, or recovery in other contexts.

There is indisputable truth to these concerns AND the discourse around this risks a figure-ground reversal—by suggesting that people die of abstinence.

Of course, no one dies of abstinence—people die from opioid use.

Published by Jason Schwartz

I have been an addiction professional and social worker since 1994. I started blogging in 2005 as the Clinical Director at Dawn Farm. I no longer work at Dawn Farm and am now the Director of Behavioral Medicine at a community hospital, and a lecturer at Eastern Michigan University’s School of Social Work. Views expressed here are my own. Keep in mind that the field, the contexts in which the field operates, and my views have changed over time.