Darvon, Darvocet Withdrawal Prompts Other Propoxyphene Recalls

Following the earlier Darvon and Darvocet recall by Xanodyne Pharmaceuticals Inc., makers of generic propoxyphene medications have begun recalling their products. Recently, Cornerstone Therapeutics Inc. said it would remove three such propoxyphene products from the market, including Balacet 325.

Propoxyphene is an opiod painkiller that was already known to be highly addictive. In November, the US Food & Drug Administration (FDA) announced that Xanodyne Pharmaceuticals Inc. had agreed to pull the medications after a study linked them to serious and possibly fatal heart rhythm problems. The agency said it was also asking the manufacturers of generic propoxyphene-containing products to remove those products from the market.

The following Cornerstone products are being withdrawn due to the FDA’s request:

• Balacet 325 CIV — 100 mg propoxyphene napsylate, 325 mg acetaminophen (NDC# 10122-301-10)

• Propoxyphene Napsylate and Acetaminophen Tablets CIV — 100 mg propoxyphene napsylate, 325 mg acetaminophen (NDC# 24486-325-10)

• Propoxyphene Napsylate and Acetaminophen Tablets CIV — 100 mg propoxyphene napsylate, 500 mg acetaminophen (NDC# 24486-326-10)

Patients should consult their physicians for instructions on how to safely transition to appropriate alternatives. For further information, patients may call Medical Information in the United States at 1 (888) 661-9260 or visit www.crtx.com.

The FDA was widely criticized for taking too long to act on propoxyphene products like Darvon and Darvocet. Since 1978, the agency received two requests from the group Public Citizen to ban propoxyphene. The United Kingdom banned propoxyphene in 2005 and the entire European Union followed suit in January of 2009. In January 2009, an FDA advisory panel narrowly voted 14-12 to recommend that the FDA remove Darvon and similar products from the market.

Rather than heed the advice of its advisory panel, the FDA decided to permit continued marketing of Darvon, Darvocet and other propoxyphene products, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of Darvocet and <"http://www.yourlawyer.com/topics/overview/darvon">Darvon side effects. While the new warning did not include mention of heart rhythm problems, the agency required Xanodyne Pharmaceuticals, the company that markets Darvon and Darvocet, to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart. The results of that study finally prompted the FDA to request the medications be removed from the market.

This entry was posted in Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.