Pharmaceutical

Pharmacists were wary of Darvon, Darvocet years before the FDA ban

Late last year, the Food and Drug Administration (FDA) ordered the removal of the prescription painkillers Darvon and Darvocet because of a risk of deadly abnormal heart rhythms. But many pharmacists say they stopped recommending the drugs years ago because of health concerns. “The reports have been out there for a long time and it hasn’t been real effective in treating pain and there were side effects,” Bob Campbell, director of the Skaggs Community Health Center pharmacy, told the News-Leader. Campbell says his pharmacy stopped stocking the drugs for hospital patients in 2007. “We just felt it was time to pull it off our formulary.”

Darvon and Darvocet, which are also sold under the generic propoxyphene, were approved by the FDA for the treatment of mild to moderate pain more than five decades ago, and had become one of the most prescribed painkillers in the country. But the drug was not without its problems. It was habit-forming and users were at risk for dangerous overdoses when they mixed the drug with other painkillers or alcohol.

Concerns about the drug’s safety have been brought to the attention of the FDA over the years, but it wasn’t until 2007, when the drug was banned in Europe, that the FDA agreed to an ongoing safety review of the drugs. Data from that study found that Darvon and Darvocet put users at significant risk for abnormal heart rhythms that in some cases was fatal. This serious side effect was noted even when the drug was used in therapeutic doses. Results from this study are what led to the FDA finally banning the drug from the U.S. market.

Lynn Morris, president and owner of the Family Pharmacy in Ozark, Missouri, told the News-Leader that tramadol would likely be the replacement for Darvon and Darvocet, but even that drug has a potential for abuse. “I tell you, we have people trying to get it too early and get large quantities of it,” Morris said. “Tramadol is a drug I think the FDA should look at listing as a controlled drug.”