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Johnson and McCaskill to FDA: Loperamide Decision Could Have Unintended Consequences

Posted 19 April 2018 | By Zachary Brennan 

Johnson and McCaskill to FDA: Loperamide Decision Could Have Unintended Consequences

FDA’s work to limit the number of doses in a package of the anti-diarrhea medicine Imodium (loperamide) could have unintended consequences for the millions of Americans who use the drug on a regular basis and may suffer from Crohn’s disease or irritable bowel syndrome (IBS), Sens. Ron Johnson (R-WI) and Claire McCaskill (D-MO) wrote in a letter to FDA Commissioner Scott Gottlieb.

The letter follows FDA’s action in January to try to limit the abuse of Imodium after the agency received reports of serious heart problems and deaths “with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication,” the agency said.

But McCaskill and Johnson warn that the decision could hurt those trying to manage a chronic disease.

And to better understand the agency’s policy, the senators are calling on FDA by 2 May to describe its process, justification and analysis underlying its decision to try to limit the number of doses in a package.

The senators also want to know the number of deaths resulting from loperamide overuse between 2013 and 2017, whether FDA sought or received comments from those using loperamide, and any applications pending before FDA for additional therapies for those suffering from IBS or Crohn’s.
 

Categories: Regulatory News

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