Recall of Darvon and Darvocet: Even Long-Term Users At Risk

Some consumers believe that if they have taken a prescription medication for a long time and noticed no side effects, then the medicine will always be safe to use. Unfortunately, that is incorrect. The recent recall of the prescription painkillers Darvon and Darvocet at the urging of the U.S. Food and Drug Administration is a potent reminder that unsafe medications may cause serious adverse effects even for long-term users.

The product: Darvon, which contains the active ingredient propoxyphene, and Darvocet which combines the pain relief ingredients propoxyphene and acetaminophen, have been prescribed for decades to treat mild to moderate pain.

The newer versions include Darvon-N, Darvocet N, (containing propoxyphene and napsylate) and Darvon Compound (containing aspirin, caffeine and propoxyphene).

Propoxypehene is also marketed under such names as Dolene, Propacet 100, Wygesic, SK-65, SK-65 APAp, Trycet, Genagesic, E-Lor, and Balacet, according to the FDA.

The new study: The serious adverse effects of Darvon and Darvocet such as heart attacks and sudden death can be brought on by small changes in a patient’s health, new research has found.

A recent study ordered by the Food and Drug Administration showed that propoxyphene, an active ingredient in Darvon and Darvocet, causes significant changes to the electrical activity of the heart, even at recommended doses. The changes increase the risk of serious abnormal heart rhythms, known as arrhythmias, that can cause heart attacks and sudden death. Accidental overdoses are another serious risk.

The FDA said the risk of adverse effects exists even for long-time users of Darvon, Darvocet and propoxyphene-containing medications. Slight changes in the patient’s health, such as dehydration, a change in medications or decreased kidney function, can trigger the sometimes deadly side effects.

At-Risk Users: Elderly patients and patients with kidney and liver disease are at the greatest risk of adverse effects from the use of Darvon, Darvocet and propoxyphene drugs. According to testimony that the American Association of Health-System Pharmacists presented to the FDA, elderly patients taking propoxyphene who experience central nervous system effects may be prone to falls that result in bone fractures, including hip fractures, that can lead to death. The group said that propoxyphene has been commonly prescribed to elderly patients, especially those living in nursing homes.

Growing Concerns: Concerns about these drugs is not new. In recent years, the avoidance of propoxyphene has been recommended by the Agency for Healthcare Research and Quality, the Veterans Health Administration and other health systems.

Several years ago, the United Kingdom and European countries banned propoxyphene-containing drugs because of deaths caused by accidental overdoses. However, Xanodyne Pharmaceuticals Inc., the maker of Darvon and Darvocet, continued marketing the narcotic painkiller in the United States. The company won approval for new versions despite reports of patient deaths related to propoxyphene.

The Recall & Your Legal Rights: In late 2010, Xanodyne Pharmaceuticals Inc., finally agreed to withdraw these unsafe drugs from the U.S. market. The FDA also urged manufacturers of generic versions of propoxyphene to follow suit.

Pharmaceutical companies have a legal obligation to manufacture and market safe and reliable medications. Patients should be able to trust that the medications they take will have the intended effect and not cause adverse health effects such as heart attacks, heart rhythm  abnormalities and accidental overdoses. Anyone currently prescribed Darvon, Darvocet or a propoxyphene-containing medication should talk to their doctor as soon as possible to discuss switching medications.

For a free consultation about any drug injury, contact the Pennsylvania unsafe drug lawyers at Munley, Munley & Cartwright to discuss your legal options.  Call 877-421-9173 or use our convenient online form.