Darvon and Darvocet

Darvon (propoxyphene) and Darvocet (propoxyphene and acetaminophen) were recalled from the U.S. market by their maker, Xanodyne Pharmaceuticals Inc., in November, 2010, at the request of the U.S. Food and Drug Administration (FDA). Although Darvon had been on the market for over 50 years, both of the pain killers can have deadly side effects.

Darvon vs. Darvocet

Darvon is an opiate used to treat mild to moderate pain. It was approved by the FDA in 1957. It was not very effective in reducing pain. Darvocet combines Darvon and acetaminophen (the active in gradient in Tylenol). Darvocet was approved in 1972. It is somewhat more effective than Darvon in treating pain.

Accidental Overdose, Suicide, and Addiction

Some of the dangerous risks of Darvon and Darvocet have been known since at least 1978 when the consumer advocacy group Public Citizen petitioned the FDA to recall Darvon due to the risk of accidental overdose, suicide, and addiction. The group petitioned again in 2006, to no avail.

Although propoxyphene is weak as a pain killer it is a strong central nervous system (CNS) depressant. When it fails to reduce the pain patients commonly take an extra dose because they either believe that they have missed a dose or that they have been under-prescribed.

Just a couple of extra pills can cause a fatal overdose. The CNS depressant can cause unconsciousness before the victim even realizes something is wrong. A person can die from Darvon or Darvocet overdose within an hour of taking too much.

Darvon’s fatal effects are so serious that it became a drug-of-choice for those who wish to commit suicide, spawning various recipes containing Darvon combined with other drugs or alcohol, commonly referred to as a “Darvon cocktail”.

Heart Rhythm and Sudden Death

Drugs containing propoxyphene drugs were banned by health authorities in Britain, in 2005, and in the entire European Union, in 2009. In July, 2009, rather than requesting a recall of Darvon and Darvocet, the FDA ordered Xanodyne to conduct a safety study of propoxyphene’s effects on the heart.

The results of that study led to the drugs finally being withdrawn the U.S. market in November, 2010, because Darvon and Darvocet can cause heart rhythm abnormalities and sudden death, even without an overdose.

The study revealed that normal doses of propoxyphene can cause the following changes to electrical activity in the heart:

  • Prolonged PR interval
  • Widened QRS complex
  • Prolonged QT interval

According to the FDA these changes in electrical activity of the heart can cause abnormal heart rhythms “that have been linked to serious adverse effects, including sudden death.”

Darvon and Darvocet victims and their loved ones may be entitled to compensation, but there is a time limit for filing a Darvon/Darvocet lawsuit. Please contact a local drug injury attorney right away.