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More Propoxyphene Drugs Recalled

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Generic drug maker Cornerstone Therapeutics Inc. recently announced it would be recalling Balacet 325 and other propoxyphene medications. The withdrawal follows Xanodyne Pharmaceuticals Inc. Darvon and Darvocet recall (both painkillers made with propoxyphene, which has been linked to serious, and sometimes fatal, heart rhythm problems).

The recalls follow a request from the US Food & Drug Administration (FDA) last month. Propoxyphene is an opiod painkiller that was already known to be highly addictive.

Since 1978, the FDA 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.

Instead, 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 a fatal overdose. 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.

The following Cornerstone products are being withdrawn due to the FDA’s request: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

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