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Public Citizen Tells FDA to Ditch Darvon,Heed Undeniable Evidence of Life-Threatening Harm

Jan. 30, 2009

Public Citizen Tells FDA to Ditch Darvon, Heed Undeniable Evidence of Life-Threatening Harm

Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group, Testifies at Public Hearing  

WASHINGTON, D.C. – New data from Europe and U.S. Medical Examiners’ reports provide further evidence that a widely prescribed painkiller should be banned. Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group, testifying today before a Food and Drug Administration (FDA) advisory committee, pointed to information from the Federal Drug Abuse Warning Network (DAWN) in 2007 that found 503 deaths determined by medical examiners to be related to the use of propoxyphene. Two-thirds of the deaths were determined to be accidental. Jurisdictions reporting to the DAWN system represent about 36 percent of the U.S. population, but are more represented in metropolitan areas.

In Florida, medical examiners are instructed to “distinguish between the drugs being the ‘cause’ of death or merely ‘present’ in the body at the time of death.” Thus, in 2007 in Florida alone there were 85 deaths in which propoxyphene was the cause of death, including 25 cases in which it was the only drug present. As in the national data, the majority of the deaths were ruled accidental, not suicidal.

This is not the first time the agency has been alerted to the profound risks posed by propoxyphene, sold under the brand name Darvon. Most prescriptions are now written for the generic versions and the combination products that contain propoxyphene, such as Darvocet, which also contains acetaminophen, also sold mainly as a generic now.

Public Citizen first petitioned the FDA to remove this drug from the market in 1978. The organization petitioned a second time in 2006 and, when the FDA failed to take action, Public Citizen sued the agency in 2008.

“Propoxyphene has one of the worst benefit-to-risk ratios I have ever seen for a drug, and yet it has long been one of the 25 top-selling drugs in the country,” Wolfe said. “Pharmacies filled 21 million prescriptions in 2007.”

The commercially successful propoxyphene was first marketed in 1957 and, until not too long ago, by Eli Lilly despite significant evidence going back more than 30 years that it is physically and psychologically addictive. It has been related to more than 2,000 accidental deaths since 1981, the majority of which were likely caused by adverse cardiac events such as slowed heartbeats, a decreased ability of the heart to contract properly and the interruption of electrical impulses transmitted in the heart. When the body metabolizes propoxyphene, it creates a toxic substance – a metabolite –

that builds up in the heart muscle. This accumulation can result in accidental overdose, especially in older patients who might already be suffering from respiratory or cardiac conditions. This drug is easily available even though it is classified as a narcotic and has been widely used as a poison in suicide cases.

In documents prepared for this advisory committee meeting, the FDA itself concluded that propoxyphene alone has “weak analgesic effects.” When taken in combination with acetaminophen, the agency reported that it did not statistically improve pain relief compared with using acetaminophen alone. There is no reason for a narcotic that provides no benefits beyond acetaminophen alone, and has considerable toxicity and significant potential for addiction and abuse, to be on the market where it can do further damage, Wolfe said.

“We should follow the lead of the United Kingdom, which found the risk of propoxyphene unacceptable and took steps to ban the drug in 2006,” Wolfe said. There is already evidence of a decrease in both Scotland and England in propoxyphene-related deaths following the announcement of the withdrawal, which was completed in January 2008.

“When the drug was initially introduced 50 years ago, much of what we now know about unintended drug reactions had yet to be understood or identified,” Wolfe said. “Propoxyphene would never get through the approval process today and, by the same token, this should indicate to the FDA that it does not belong on today’s market, period.”