Darvocet®

• Home
• Darvocet

Darvocet®

What Is Darvocet®?

Darvocet® and its relative, Darvon®, are narcotic prescription medications for treating mild to moderate pain.

Propoxyphene is the active ingredient in both drugs. The approval of Darvocet® followed that of Darvon®. Darvocet® contains an additional active ingredient, acetaminophen, which enhances the pain-relieving effect of propoxyphene and reduced fever. Darvon® was approved in 1957. Darvocet® first came on the market in October 1972.

Problems with Darvocet®

Problems with the pain medications’ ingredient propoxyphene continued to come to light over the years. The most recent concern is the drug’s potentially fatal effect on the heart. The FDA collected and analyzed data from numerous past studies indicating that propoxyphene can cause serious abnormalities in the electrocardiograms of patients taking the drugs.

The abnormalities could produce the following adverse reactions, which sometimes are fatal:

• Arrhythmias, or abnormal heart rhythms, that were too fast, too slow, or irregular
• The origin of the heartbeat was in the wrong part of the heart muscle
• Heart attack
• Cardiac arrest
• Congestive heart failure

Another earlier concern required the drug company to add a warning to the drug label. The drug was found to be associated with an unusually high rate of overdose, whether intentional or unintentional.

The difference between a prescribed dose of the medication and an overdose was slim enough that some patients were inadvertently taking too much of the medication, perhaps thinking that if some were good, more would be better. In addition, some patients were deliberately taking too much of the medication because their tolerance had grown.

An FDA-required warning was added to the drug label.

"Risk of Overdose. There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon."

Darvocet® Recall

Some members of the medical community and the FDA advisory panel reviewing the medication wanted Darvocet® and Darvon® recalled when its overdose risks became known. At the time, however, the FDA ruled that the drugs’ benefits outweighed its risks.

Sidney Wolfe, director of the Public Citizen’s Health Research Group, wanted the medication to be recalled when five years earlier it had been pulled from the market in Great Britain and one year previously in the European Union.

The FDA requested a recall of Darvocet®, Darvon® and propoxyphene-containing drugs in November 2010 after reviewing data that showed that the drug puts patients at risk of fatal heart problems.

Consumer advocate groups as well as lawyers for dangerous drugs say the recall came tool late. If you or a loved one has suffered a heart side effect while taking Darvocet®, Darvon® or another propoxyphene-based drug, please contact us for help.

Our Darvocet® attorneys are investigating lawsuits on behalf of patients who have been harmed by the defective drug and would like to help you recover the compensation you deserve.