Darvocet / Darvon

Darvocet contains two different drugs, propoxyphene and acetaminophen. Propoxyphene is classified as a narcotic pain reliever, and is an opioid used to treat mild to moderate pain. Darvocet is used to treat pain when it is not accompanied by a fever. Originally developed by Eli Lilly & Co., it was put on the market in 1957. According to the FDA, Darvocet was prescribed to 10 million people in 2009.

In 2009, an FDA advisory panel voted 14-12 to remove Darvocet and similar drugs from the market because of reports of severe side effects. In spite of this, the FDA continued allowing Darvocet to be sold and marketed. The FDA did require that the label on Darvocet be updated to warn patients of overdose risks.

In some studies, it was found that propoxyphene, an active ingredient in Darvocet, had a high risk of overdose. Also, this drug had been linked to heart rhythm problems as well.

Finally, a study found that even when taken at the prescribed dose, propoxyphene caused significant changes to the electrical activity in the heart. When this activity is interfered with in the heart, it can cause abnormal heart rhythms and even sudden death. The FDA also found that it was impossible to monitor these risks and asked the manufacturers to withdraw Darvocet, its generic version and similar drugs from the market in 2010.

The FDA also urged doctors to stop prescribing Darvocet immediately, but advised patients to continue taking the drug and to consult a doctor to find a new alternative. It was also stated that patients taking Darvocet should not immediately stop taking the drug, due to the fact that it could cause severe withdrawal symptoms.

Serious Side Effects may include:

• Shallow breathing, slow heartbeat, feeling like you might pass out
• Chest pain, feeling short of breath
• Confusion, unusual thoughts or behavior
• Seizure (convulsions)
• Nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
• Less serious side effects include:
• Feeling dizzy or drowsy
• Mild nausea, vomiting, upset stomach, constipation
• Headache, blurred vision
• Dry mouth