Senators Ask Gottlieb to Justify Restrictions on Loperamide

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.