Today’s post comes from guest author Brenda Fulmer from Pasternack Tilker Ziegler Walsh Stanton & Romano.
Darvon and Darvocet, the branded versions of the prescription medication also known as propoxyphene, have been used for decades to treat mild to moderate pain. These drugs have been taken by millions of patients who suffered from arthritis, back injuries, trauma, surgery, and other painful conditions. These drugs have been the “go-to” painkillers for a number of primary care physicians and ER doctors for years.
Their widespread use, however, has given patients and doctors a false sense of safety. Darvon and Darvocet, which most recently have only been sold as propoxyphene by generic manufacturers, were finally recalled and pulled from the market in late 2010, after a number of patients suffered injuries or died as a result of their ingestion of the drugs.
Since propoxyphene was first launched in 1957, the Food and Drug Administration (“FDA”) has received more than 2,100 reports of serious problems relating to use of the medications, including the following:
- Cardiac arrest;
- Overdose; and
Since the FDA may only receive reports for less than 1% of adverse drug reactions, and the safety issues associated with Darvon and Darvocet have not been well publicized prior to 2010, it is likely that tens of thousands of patients may actually have been harmed by these commonly-prescribed pain medications. Drug safety advocates have been urging the FDA and the manufacturers of Darvon and Darvocet to remove propoxyphene from the market in the United States since 1978. Ralph Nader’s consumer advocacy group, Public Citizen, has been particularly vocal in its efforts to get Darvon and Darvocet recalled.
Sadly, it took more than 30 years for the FDA to finally heed the call. In 2010, the FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that Darvon, Darvocet, and propoxyphene put patients at risk of potentially serious or even fatal heart rhythm abnormalities. These ventricular arrhythmias can be fatal.
As a result of this further adverse safety data, the manufacturer of these drugs, Xanodyne Pharmaceuticals Inc., agreed to withdraw the medication from the U.S. market at the request of the FDA. When the FDA issued its request for market withdrawal of Propoxyphene, an estimated 10 million persons in the U.S. were taking the pain medication. Numerous lawsuits have been filed against the manufacturers of Propoxyphene drugs alleging that the pain medication causes heart problems such as heart arrhythmia and sudden heart related deaths.
Brenda Fulmer is a shareholder at the law firm Searcy Denney Scarola Barnhart & Shipley in West Palm Beach and partners with Pasternack Tilker Ziegler Walsh Stanton & Romano in the litigation of drug and pharmaceutical mass tort cases. Ms. Fulmer graduated from the University of South Florida with a B.S. in Finance, and received her Juris Doctor degree cum laude from Stetson University College of Law. For the past 17 years, she has represented thousands of mass torts plaintiffs in both state and federal courts who have been injured by defective medical devices and drugs.