50 Years of Side Effects Leads to Darvocet Recall
Patients who have suffered cardiac injury after using prescribed doses of the painkiller propoxyphene can be educated on the historical lead-up to the 2010 Darvocet recall.
The FDA first approved of propoxyphene in 1957 as a mild post-operative opiate painkiller. It is marketed by drug maker Xanodyne as Darvon, or when combined with acetaminophen, as Darvocet.
The FDA has received requests to remove the drug from the market since 1978, when watchdogs such as the Public Citizen’s Health Research Group complained about the drug not only being highly addictive but also leading to suicidal tendencies and heart damage.
Darvocet recall in the U.K.
In 2005, a Darvocet recall was issued in the U.K. by the Medicines and Healthcare Products Regulatory Agency (MHPRA). The U.K. Darvocet recall was due to severe and often fatal heart-related side effects. Following the U.K. ban, Public Citizen again called for the FDA to follow suit and issue its own Darvocet recall, referencing once again the drug’s “high toxicity” and “extremely low margin of safety.”
In early 2009, an FDA Advisory Committee convened to explore the possibility of a Darvocet recall. The Committee concluded that a U.S. Darvocet recall was in order, given that the scientific evidence now available to them showed conclusively that propoxyphene significantly impacted the electrical patterns of the heart, including extending the PR and QT intervals, even when taken by healthy patients at the recommended dosage.
These electrical aberrations are detectable on an ECG, and can lead to heart arrhythmia, or severe versions of arrhythmia such as ventricular tachycardia or “torsade de pointes,” a rare disease that interferes with blood circulation and can cause cardiac arrest even in young and active patients.
FDA finally acts on dangerous Darvocet side effects
Many Darvocet lawyers were surprised when the FDA chose not to act on the 2009 Advisory Committee’s recommendation for a Darvocet recall. Instead, they chose to add a strong warning to the drug’s label, and to demand that drug maker Xanodyne carry out its own studies on Darvocet side effects.
Later that year, the U.K. Darvocet recall was expanded by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to include all of Europe.
Finally, in 2010, over 50 years after initially approving the painkiller for the market, the FDA issued a Darvocet recall. Xanodyne agreed to comply with the Darvocet recall, as evidence from their recent studies only confirmed and strengthened previous findings.
Public Citizen criticized the FDA for its lengthy delay in banning the drug, alleging that several thousand patient deaths might have been avoided had the FDA followed suit with the U.K. and issued a Darvocet recall in 2005. A Darvocet lawyer will weigh the cost of these critical delays when bringing a Darvocet plaintiff’s case to trial.