On 1/30/09 an advisory committee to the U.S. Food & Drug Administration (FDA) recommended a ban on the popular pain medication, Darvon that has been used to treat pain for more than 50 years. According to government health and safety experts, Darvon has been linked to addiction and other serious, life-threatening side effects.
Darvon (generic: propoxyphene) has been associated with over 10,000 confirmed deaths and 2,110 reported accidental deaths in the United States.
About Darvon / Propoxyphene
Darvon was first approved for sale in the United States 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 approximately 23 million prescriptions for Propoxyphene filled, making the drug the 12th most commonly prescribed generic drug in the United States. Four companies account for more than 91 percent of U.S. prescriptions.
Darvon is also sometimes combined with a dose of acetaminophen and marketed under the name Darvocet.
What’s the problem?
Darvon or Propoxyphene has been associated with 2,110 reported accidental deaths in the United States since 1981. A large proportion of these deaths occur because most of the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression. Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.
Fatalities within the first hour of overdosage are not uncommon. In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour (5% occurred within 15 minutes).
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 Journal of the American Medical Association, published a study over 36 years ago in which they found that Darvon or Propoxyphene was no more effective that two aspirin tablets.
- Public Citizen – Petitions FDA to Ban Darvocet Products