FDA calls for packaging change to opioid antidiarrheal to limit overdose risk

FDA Commissioner Scott Gottlieb, MD, said Tuesday the agency sent letters to manufacturers of the diarrhea medication loperamide — known by the brand name Imodium — requesting the over-the-counter medication be repackaged to reduce the risk of overdose.

FDA requested the companies alter the drugs packaging to reduce the overall quantity of the loperamide per package to decrease the likelihood of individuals using too much of the drug at once. Though the drug is safe in approved doses, ingesting too much loperamide can cause serious heart issues and death. The repackaging requests are a part of the agency's efforts to address the nation's ongoing opioid crisis.

"Abuse of loperamide has been increasing in the United States," Dr. Gottlieb said. "When used at extremely high and dangerous doses, it's seen by those suffering from opioid addiction as a potential alternative to manage opioid withdrawal symptoms or to achieve euphoric effects of opioid use."

The agency also plans to encourage online retailers of the drug to take voluntary steps to address the issue.

To read Dr. Gottlieb's full statement, click here.

More articles on opioids: 
Opioid distributors shipped 21M pills to West Virginia town with 3k residents: 7 things to know 
Fentanyl seizure contained enough doses to kill New Jersey and NYC's entire population 
FDA, FTC crack down on unapproved opioid cessation products: 3 things to know

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