Opioid Withdrawal’s Potential CV Risk Drives Advisory Panel For Constipation Drugs

FDA seeks advisory committee’s advice on whether cardiovascular outcomes trials for peripherally active mu opioid receptor antagonists should be required and the timing of any such studies.

FDA will ask its Anesthetic and Analgesic Drug Products Advisory Committee on June 11-12 to consider whether a possible association exists between opioid withdrawal and an increased risk of cardiovascular adverse events with chronic use of peripherally active mu opioid receptor antagonists.

The agency is requesting the committee discuss whether the totality of data suggests a CV safety signal for the class of drugs in development for treating opioid-induced constipation (OIC), according...

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