Darvon, Darvocet Stronger Warning

Almost Taken Off The Market

Expect to see a new stronger warning on the label of the painkillers, Darvon and Darvocet.

The Food and Drug Administration (FDA) has called for the additional warning because of a danger of overdose for the drug, propoxphene, after noting higher-than-expected fatality rates and possible toxic effects on the heart.

Darvocet is a combination of acetaminophen and propoxyphene, a group of narcotic pain relievers. Darvon contains propoxyphene. Both are highly addictive. 

Public Citizen, the consumer group, had asked for the drugs to be withdrawn from the market, and an expert advisory panel last February had concurred voting 14-12 to ban the drug products, but the FDA will allow them to stay with the stronger warning.   

The drugs had been available since 1957. Over that time period, 91 deaths related to propoxyphene have been reported to the FDA, reports ABC News.  The data is not clear as some of the deaths were suicides and involved other drugs. 

Propoxyphene is similar to methadone in that it is an opioid painkiller used when Tylenol doesn’t help.

Another FDA advisory panel last week decided that prescription products containing acetaminophen (Tylenol) should be given in smaller doses and the Extra Strength Tylenol should be sold by prescription only to reduce the dangers of serious liver injury.

The American Geriatrics Society has discouraged the use of nonsteroidal anti-inflammatory (NSAIDS) drugs in older patients, so propoxyphene –containing analgesics, with fewer side effects, were considered a better option.

Dr. Sidney Wolfe, of the advocacy group Public Citizen, says the FDA is allowing a risky drug to stay on the market. 

"The agency has decided to allow the continued marketing of a drug with the most patient-unfavorable ratio of risks of any drug I have ever seen," Wolfe said. "We will either appeal this anti-public health decision to the new FDA commissioner or argue in federal court that the decision was arbitrary and capricious."

Instead, the FDA will require manufacturers to stress the importance of taking the drug as directed to avoid the risk of overdose.     

"All current pharmacologic options for pain have significant liability.  Given the data currently available to FDA, propoxyphene is an acceptable choice for the treatment of mild to moderate pain when it's taken as directed”  Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said to ABC News.   

The American Academy of Pain Medicine issued a study this year that 2 million people had prescriptions for propoxyphene- containing product.  Their data suggested that more than 500,000 Americans take the drug every day for pain.   #