FDA asks drugmakers to limit amount of opioid drug in packaging
(Reuters) – The U.S. Food and Drug Administration is asking manufacturers of a common opioid medicine to change the way the drug is packaged, as part of efforts to deter its abuse amid an opioid epidemic in the United States.
The FDA said on Tuesday it sent letters to manufacturers of diarrhea medicine loperamide, asking them to ensure that packages contain only a limited amount of the drug that is appropriate for use for short-term diarrhea.
The agency wants to eliminate the large bottles in which loperamide is often sold because the abuse of the drug requires such large quantities.
The FDA is also asking online retailers which sell loperamide to take voluntary steps to address the issue. It is also influencing doctors to prescribe shorter-duration opioids.
The actions come amid reports of serious heart problems and death in patients who have taken higher-than-recommended doses of the drug or have misused it, the FDA said.
They are also part of the agency’s efforts to reduce patients’ exposure to opioids, which killed more than 42,000 Americans in 2016, according to estimates from the Centers for Disease Control and Prevention.
Loperamide is used to treat short-term symptoms of diarrhea, including Traveler’s diarrhea — a digestive tract disorder that commonly causes loose stools and abdominal cramps.
The drug is sold under the brand name Imodium A-D, as store brands and as generics. Imodium is marketed by Johnson & Johnson in the United States.
Reporting by Divya Grover in Bengaluru; Editing by Sai Sachin Ravikumar