• Darvon®
• Darvon-N®
• Darvon® Lawsuit
• Darvon® Lawyer
• Darvon® Recall
• Darvon® Side Effects
• Contact a Lawyer

Find a Lawyer in Your State

Need Help?

• Accutane®
• Cerebral Palsy
• Darvocet®
• Denture Cream
• Depuy ASR™ Hip Implant
• Fosamax® Femur Fracture
• MiniMed Insulin Pump
• Multaq®
• Nephrogenic Systemic Fibrosis
• Paxil® Birth Defects
• Propecia®
• Shoulder Pain Pump
• Topamax®
• Truck Accident Lawyer
• Wellbutrin®
• Yaz® Birth Control

Warning: Darvon® has been recalled due to fatal side effects. Consult a Darvocet® attorney about an injury claim.

Darvon® Warning and FDA

The U.S. Food and Drug Administration (FDA) called for a boxed warning on Darvon®, Darvocet® and other propoxyphene-containing painkillers in July 2009. The warning cautioned about the risk of the medication’s causing accidental or intentional overdosage.  The government agency ordered the manufacturer Xanodyne to study the following:

• Overdose rates that were higher than comparable medications to treat pain
• Toxic effects on the heart when the drug was taken at normal therapeutic doses

Warning Label on Darvon®

The warning label on propoxyphene, the active ingredient in Darvon, cautions doctors and patients on the risk of overdose.

“There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS [central nervous system] depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon.”

The label goes on to say that most of the propoxyphene deaths have occurred in patients with emotional problems or suicidal tendencies and/or in those who have taken other CNS depressants including tranquillizers, sedatives, muscle relaxants or antidepressants.

The label also warns of the following:

• Respiratory depression — the warning explains that respiratory depression is one of the main hazards from opioid medications such as propoxyphene (respiratory depression is a breathing rate of fewer than 12 breaths per minute producing a failure of the lungs to be fully ventilated and the blood to be adequately oxygenated)
• Severe low blood pressure
• Intracranial pressure or increased pressure within the skull
• Severe or lethal drug interactions

Darvon® Boxed Warning

The warning on the drug label is included in a black line-ruled box called a black box warning.  This is the strongest caution the FDA can put on a label insert. At the same time the FDA required Xanodyne to strengthen the overdose black box warning, the agency required the company to undertake new studies on how propoxyphene-containing drugs might harm the heart.

Darvon® received market approval from the FDA on Aug. 16, 1957.  Due to its many dangerous, potentially lethal side effects, the drug has been controversial for years.  Finally, on Nov. 19, 2010, the FDA required Xanodyne to take Darvon®, Darvocet® and all other propoxyphene-containing drugs off the market.

The final blow came when studies showed propoxyphene-containing drugs had the potential to cause deadly heart problems that made its risks outweigh its benefits.

If you have suffered a side effect of Darvon® and feel that you were not adequately warned of the potential risks associated with the drug, contact a Darvon®/Darvocet® lawyer today.