FDA pulls Darvocet®, Davron® Pain Meds Off Market
November 19, 2010 – According to an FDA announcement, Xanodyne Pharmaceuticals Inc. has agreed to withdraw its prescription pain medications Darvocet and Davron (Darvon N 100 mg) from the market. The FDA also asked generic makers of the pain medicine to voluntarily remove their products.
“The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks,” the FDA said in today’s statement.
The move to recall comes after the drugs’ active ingredient propoxyphene was found to put patients at risk of potentially fatal heart rhythm abnormalities.
“We recommend to physicians stop prescribing the drugs. As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay,” said Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology.
FDA Discusses Ban on Darvon & Darvocet
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. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.