FDA strengthens overdose warnings for painkiller Darvon

Today, the Food and Drug Administration said medicines containing the painkiller propoxyphene will be required to carry a black box warning—the agency's strongest—about the risk of overdose that can lead to death.

The FDA stopped short of pulling the drug off the market, which two of its advisory committees recommended in February due to both accidental and intentional overdoses. But the agency also added the requirement that a medication guide stressing safe usage of propoxyphene products be handed out to all people who are prescribed these drugs.

Millions of prescriptions are written for propoxyphene each year. It is sold as a generic medicine and under the brand name Darvon. It is also used in various generic and branded combination products, such as Darvocet, that contains acetaminophen. At the February meeting of the advisory committees, the FDA said its analysis found more than 2,100 reports of serious problems—including suicide, overdose, and cardiac arrest—associated with propoxyphene use since it was first launched in 1957. This includes 1,452 deaths (98 deaths in 2006 and 2007).

Propoxyphene has been banned in Sweden, Switzerland, and the United Kingdom. The FDA said Tuesday it denied a citizen's petition filed in 2006 by the watchdog group Public Citizen urging the ban of the drug in the U.S. because the Agency felt its pain-relieving benefits outweighed its safety risks.

CR's Take: Our Best Buy Drugs report on opioid pain medicines recommends against using products containing propoxyphene because of safety concerns. If you and your doctor decide you need an opioid pain drug, we recommend generic codeine with acetaminophen, generic morphine, generic oxycodone, or generic oxycodone with acetaminophen. To learn more about pain medicines, download our free report.

Note: An FDA panel recently urged that certain acetaminophen products be banned and others get a black-box warning about the risk of liver damage that can be fatal, so our recommendations may change depending on how the FDA responds to this advice. In the meantime, we advise: Don't exceed the labeled maximum dosage of acetaminophen, avoid acetaminophen if you drink heavily or have liver disease, and don't use more than one acetaminophen product at a time.

—Steve Mitchell, associate editor, Best Buy Drugs