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The opioid painkillers Darvon® and Darvocet® were recalled by the drugs' manufacturer and the U.S. Food and Drug Administration (FDA), Nov. 19, 2010. Propoxyphene is the agent that was the cause for the recall. Darvon® contains propoxyphene. Darvocet® contains both propoxyphene and acetaminophen as the active ingredients.

Darvon® Risks and FDA Recall

The recall was announced after years of controversy over the drug's safety. The final concern that prompted the recall was the FDA conclusion drawn from recent clinical studies that propoxyphene had the potential to cause serious, sometimes, fatal harm to patients' hearts. Clinical reports showed the drug led to electrical changes in the heart that caused it to beat:

• Too fast: tachycardia (over 100 beats per minute)
• Too slowly: bradycardia (fewer than 60 beats per minute)
• Irregularly

Propoxyphene can affect where in the heart the electrical impulse is originated. This can cause an irregular heartbeat. Another serious concern was the drug's link to suicidal thoughts and actual suicides.

Both the effects on the heart and the concern over possible suicide led to black box warnings on the drugs' literature insert. A black box warning, included at the mandate of the FDA, is the most serious warning a drug label can contain. A black box is literally a black line in the form of a square surrounding the especially serious warning on the medicine's insert enclosure.

Other serious problems associated with Darvon® and Darvocet® are the drugs' potential for abuse and the dangerous effects when taken by persons who drink alcohol. Some of the more common Darvon® side effects reported by patients include:

• Accidental and intentional overdose
• Drug dependence
• Cardiac arrest
• Coma
• Nausea
• Respiratory arrest
• Vomiting
• Dizziness
• Convulsion
• State of confusion
• Diarrhea

Darvon® Recall Lawsuits

Many consumer advocates argue that the Darvon® recall came too late. Millions of people have been treated with propoxyphene, meaning millions of people are at risk of suffering harm. The dangers are serious and can lead to sudden death. As a result, Darvon® recall lawsuits are being investigated nationwide for people who believe they have been harmed by the drug.

Contact A Darvon® Recall Attorney

You should contact an attorney about your situation if you think you might have a case. Our Darvon® recall lawyers are offering free case evaluations for people who have experienced heart-related side effects or other life-threatening injuries.