Pharmaceutical

Consumer group lashes out at FDA over delayed Darvocet ban

Public Citizen, a national consumer advocacy group that has twice petitioned the U.S. Food and Drug Administration to ban Darvocet, Darvon, and other propoxyhene products from the market, is now calling on Congress to investigate the agency’s leadership, angrily asserting that its inaction has contributed to the deaths of more than 1,000 Americans.

Propoxyphene is an opioid pain medication used to relieve mild to moderate pain. Darvocet is a composite of propoxyphene and acetaminophen. Darvon is propoxyphene only. Propoxyphene drugs have been on the market since 1957.

According to Public Citizen, the FDA cited dangers that were already widely known and understood when it announced its decision to yank the drugs from the market. The organization said the FDA’s announcement of the ban on November 19 was “a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller,” especially because it came six years after the UK banned the drug and 2 years after the European Union ordered its removal.

The FDA, however, says its ban on propoxyphene was based on “new data” that shows Darvocet causes significant changes to the electrical activity of the heart, which increases the risk of serious abnormal heart rhythms and heart failure.

Nonsense, says Public Citizen, whose officers first petitioned the FDA to ban the drug in 1978 because of its toxicity. “The FDA’s claim that this is the first evidence that the drug is dangerous at the ‘standard therapeutic dose’ thus rings dangerously hollow,” the group said on its website, adding that research revealing propoxyphene causes a heart-toxic metabolite to accumulate in the body goes back more than 30 years.

Public Citizen again petitioned the FDA to ban Darvocet and similar drugs from the market after the UK ban was announced. Unfortunately, according to Public Citizen, their petition “did not even result in an FDA advisory committee hearing until we had sued the agency in 2008 to force them to respond.”

Public Citizen issued a heated statement, sounding frustrations reminiscent of critics who say the agency has lost its ability to regulate the nation’s pharmaceutical drugs and food supply.

“The FDA’s pitiful excuse that it needed to order a human study to find that ‘the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities’ before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world – which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.”

“We will ask for and support a congressional investigation into whom in the FDA, specifically in the Center for Drug Evaluation and Research, was responsible for the loss of so many lives in this country,” the organization said.