Withdraw Propoxyphene from the U.S. Market, ASHP Tells FDA

1/30/2009

The Food and Drug Administration should pull propoxyphene from the U.S. market because of its lack of efficacy and potential patient risks that outweigh any potential benefit, ASHP testified to two of the agency’s committees today.

Cynthia Reilly, B.S. Pharm., ASHP director of practice development, testified before the FDA’s Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which are considering whether the FDA should take regulatory action involving propoxyphene.

Reilly cited ASHP policy, the scientific literature, resources such as the “Beers Criteria,” and the Agency for Healthcare Research and Quality to state its case for the withdrawal of propoxyphene. She noted that the drug is inadequate for managing severe pain and leads to increased risk for adverse side effects in elderly people and those with kidney and liver disease. Reilly’s testimony also pointed to alternative analgesic therapies that have been found to be more safe and effective.

Click here to read ASHP’s testimony.