Health Research Group Petitions to Phase Out the Sale of the Painkiller Propoxyphene (DARVON, DARVOCET, and Generic Versions)

On Feb. 28, 2006, the Health Research Group petitioned the Food and Drug Administration (FDA) to immediately begin phasing out the sale of the dangerous painkiller propoxyphene (DARVON). There are many generic versions of propoxyphene on the market, as well as a number of products that combine propoxyphene with acetaminophen (TYLENOL). These products are sold as DARVOCET and are also widely sold as generic drugs. A phased withdrawal, instead of an immediate ban, is necessary because of the addicting properties of the drug and the need to switch patients to other painkillers.

Propoxyphene is a narcotic that causes dependence and has repeatedly been shown in “gold standard” controlled clinical trials to be a relatively weak painkiller. When propoxyphene is broken down in the body (metabolized), a compound that is toxic to the heart is produced.

Propoxyphene was approved for sale in the U.S. in August 1957. This almost 50-year-old drug, despite its poor painkilling qualities, dependence potential, and toxicity, continues to be one of the most widely prescribed drugs in this country. In 2004, there were 23 million prescriptions dispensed for the drug with sales that year of $291 million.

Propoxyphene has been associated with over 10,000 confirmed deaths and 2,110 reported accidental deaths in the U.S. from 1981 through 1999. Because toxicity develops with the drug at only slightly above the recommended daily dose, propoxyphene is consistently mentioned as one of the top ten drugs found in peoples’ systems during autopsies.

The full text of our petition can be found on the Health Research Group'sWeb site. 

Other countries are already acting to protect their citizens from propoxyphene. On Jan. 31, 2005, the British equivalent of the FDA announced that propoxyphene products would be removed from the market within one year. This decision was based on the fact that it is a poor pain reliever and that the risk of toxicity in overdose, both accidental and deliberate, is, according to the British government, “unacceptable” (see Worst Pills, Best Pills News April 2005).

Propoxyphene is on a list of drugs created by a group of drug safety experts that are inappropriate for use in patients over the age of 65. Despite being on this list for years, recent research indicates that too many senior citizens are still being prescribed propoxyphene (see Worst Pills, Best Pills February 2002).  

The Health Research Group has a long history in trying to remove propoxyphene from the market. In November 1978, we proposed significantly altering propoxyphene’s regulatory status in either of two ways. First, a petition was filed with Department of Health, Education and Welfare (HEW) to ban the drug as an “imminent hazard” to the public health. In the other option we proposed that HEW tighten restrictions on the drug’s use by placing it in Schedule II of the Controlled Substances Act (CSA). Schedule II of the CSA is reserved for highly addictive drugs such a pure morphine.  

A key factor in the HEW decision to reject our proposals was a claimed commitment by Eli Lilly & Company, the original developer of propoxyphene, to an “educational program” intended to sensitize prescribers and patients to the hazards of propoxyphene products. In 1978, an HEW appraisal of Lilly’s efforts reported: “Lilly has not conducted its campaign to prescribers as FDA had expected. Detail persons [drug sales personnel] visiting physicians failed to emphasize the user warnings in the majority of visits, left samples of Darvon in 50 to 75 percent of visits, and on the average spent less than half of the time on Darvon during the visits.”

It appears that Eli Lilly converted its education program into a marketing initiative. Voluntary promises by the drug industry to do the right thing for the public almost never, if ever, protect the public from needless harm.

Many studies have shown the relative ineffectiveness of propoxyphene as a painkiller. In a study published 36 years ago in the Journal of the American Medical Association, propoxyphene was found to be no more effective that two aspirin tablets.

A recent comprehensive review of randomized clinical trials, the scientific “gold standard,” conducted by the highly regarded Cochrane Collaboration found that for most kinds of pain, ibuprofen (MOTRIN) is more effective than propoxyphene with acetaminophen (DARVOCET). Acetaminophen is the active ingredient in TYLENOL. Furthermore, codeine with acetaminophen (TYLENOL WITH CODEINE) was found to be more effective than propoxyphene in combination with acetaminophen, although that difference was not statistically significant. Ibuprofen, however, was a significantly stronger painkiller than the propoxyphene compound, requiring that fewer patients be treated at the standard dose for at least one of those patients to achieve 50 percent pain relief.

The FDA is well aware of the dangers to which propoxyphene exposes the public. The black box warning that now appears in the professional product labels for all propoxyphene-containing products is at the top of the page. A black box is strongest type of warning that the FDA can request. Unfortunately, professional product labels are not routinely distributed to prescription drug consumers at the pharmacy and consumers may be unaware that a drug they are prescribed may require a black box warning.

What You Can Do

If you are taking a propoxyphene containing product consult your physician about switching to a more effective, safer painkiller.

You should not stop taking propoxyphene suddenly because of the possibility of withdrawal symptoms.