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Update: Propoxyphene has been recalled because of deadly side effects. The recall involves Darvocet®, Darvon® and all generic versions of these drugs.

Propoxyphene, first made by Eli Lilly and distributed in 1957, is the active ingredient in Darvon® and, along with acetaminophen, an active ingredient in Darvocet®.

The medications have a long history of complaints of side effects, most of them acknowledged by the Food and Drug Administration (FDA), which took its time pulling the drugs from the market, according to many doctors and researchers.

Propoxyphene and the FDA

Complaints about side effects dogged the drug's reputation for years. The FDA added warnings to the drug's label, cautioning prescribing physicians and patients about these harmful side effects.

Before one of the propoxyphene containing drugs, Darvocet®-N, was on the market, its makers reported to the FDA that during clinical trials the most common adverse reactions included dizziness, sedation, nausea and vomiting. Other adverse reactions found during clinical trials included constipation, abdominal pain, rashes, headache, lightheadedness, weakness, euphoria, dysphoria (sadness), hallucinations, and other visual disturbances.

After a drug is on the market and many thousands of patients have taken it, other side effects come to light.

Once on the market, the propoxyphene side effects that reportedly occurred most often include:

• Suicide, attempted and completed
• Overdosage, intentional and unintentional
• Drug dependence
• Cardiac arrest
• Coma
• Drug toxicity
• Nausea
• Respiratory (breathing) arrest
• Vomiting
• Dizziness
• Convulsion
• Confusion
• Diarrhea

Propoxyphene Black Box Warning

Concerns about intended and unintended overdosage prompted the FDA to require the current drug manufacturer, Xanodyne Inc., put a black box warning on its label. A black box warning is the strongest caution used on a drug label. The propoxyphene black box warning cautioned physicians and patients in bold type surrounded by a black box that:

• There had been "numerous cases of accidental and intentional overdose"
• Fatalities within the first hour of overdosage were common
• Propoxyphene should not be taken with other medications such as tranquilizers, sedatives, antidepressants, and muscle relaxants
• Propoxyphene should not be prescribed for patients who are suicidal or have a history of thinking about suicide

Numerous other warnings were printed on the medication label, including an admonition not to prescribe the medication to alcoholics.

Propoxyphene Recall

The final complaint was about propoxyphene's danger to the heart. In a safety study commissioned by the FDA, propoxyphene was found to endanger the electrical activity of the heart as seen on the electrocardiograms of healthy volunteers. The abnormal rhythms of the heart were serious enough to be fatal.

The FDA finally decided that the "risk-benefit" ratio had been altered. The risks of using propoxyphene outweighed its benefits, and propoxyphene was recalled from the market.

Millions of Americans have been prescribed these drugs, meaning millions of people are affected by this recall. If you've been harmed by Darvocet® or Darvon®, please contact our propoxyphene lawyers for qualified legal help. We will evaluate your case and fight to get you the compensation you need.