www.fdanews.com/articles/186555-senators-ask-gottlieb-to-justify-restrictions-on-loperamide
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Senators Ask Gottlieb to Justify Restrictions on Loperamide
April 25, 2018
The Senate Homeland Security & Governmental Affairs Committee requested more information from the FDA on the agency’s decision to limit access to loperamide.
In January the agency announced plans to limit the availability of over-the-counter dosages of the drug — commonly used to treat Crohn’s disease and Irritable Bowel Syndrome — because it is being misused to treat opioid withdrawal.
The FDA policy, which would limit over-the-counter packs to eight pills, could create an undue burden for those who genuinely need it, the senators wrote.