Nov. 1, 2018

FDA Likely to Decide Friday Whether to Approve Super-Strong, Super-Dangerous Opioid Medication

FDA Advisory Committee Chair Warns Against Approval; Public Citizen Experts Are Available to Comment

The U.S. Food and Drug Administration (FDA) is to decide by the end of the day Friday whether to approve a highly controversial new opioid medication that even the agency’s own advisory committee chair warned against.

Public Citizen experts will be available to comment when the decision is announced.

In an October letter (PDF) to the FDA, Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, joined Public Citizen in urging the agency to reject the medication, which is called sufentanil sublingual tablet (Dsuvia) and would be used to treat moderate-to-severe acute pain in a medically supervised setting.

If approved, Dsuvia will be abused and start killing people as soon as it hits the market, Public Citizen maintains.

Dsuvia is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. The advisory committee voted 10-3 in October for the medication to be approved. Brown could not attend the meeting. Joining Brown on the letter were Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group; Dr. Michael Carome, director of the group; and Dr. Meena Aladdin, a health researcher.

U.S. Sen. Ed Markey (D-Mass.) also is calling on the FDA to reject Dsuvia.