Darvocet Side Effects Study Resulted in FDA Ban on Darvocet
The results of studies on Darvocet side effects had led to a ban on the popular pain medication by the US Food and Drug Administration (FDA). The FDA ban on Darvocet comes in light of studies that have tied the drug to cardiac arrhythmia and other heart problems. The agency mandated that Xanodyne, the drug’s manufacturer, complete a new study into Darvocet side effects, which forced a Darvocet recall on the opioid painkiller.
Hazards of Darvocet side effects
Although doctors had prescribed the drug, a combination of acetaminophen and the opioid propoxyphene, for over fifty years, the Darvocet side effects have only become apparent in recent years. Studies have linked the drug to a disruption in the electrical activity in the heart. Due to its weak effectiveness at treating pain and its dangerous side effects, the government called for an FDA ban on Darvocet and for the manufacturers to start a Darvocet recall.
FDA Studies on the side effects of Darvocet
The FDA ban on Darvocet came in response to studies into the Darvocet side effects, which the agency prompted the manufacturers to investigate. The FDA study found that the drug can cause “significant changes to the electrical activity of the heart” and can “increase the risk for serious abnormal heart rhythms”. Industry observers have speculated that Xanodyne did not initiate a study immediately, fearing the financial ramifications of an overall Darvocet recall, until prompted by the FDA.
Consumer concerns spark Darvocet recall
The most recent studies were not the first occasion in which Darvocet side effects have raised patient concerns. Public Citizen, a consumer awareness group, lobbied for an FDA ban on Darvocet as far back as 1978. The group also asked the agency to force a Darvocet recall in 2006, shortly after British regulators banned the use of the drug in the UK. In 2009, the FDA called for a “black box” warning on the drug, the strongest form of warning label, but did not enforce a ban right away.
FDA ban on Darvocet follows UK, EU moves
After several reports of heart attacks attributable to Darvocet side effects, British regulators called for a ban on the drug. The European Union’s regulatory agency enforced a similar ban in 2009. The FDA ban on Darvocet only came into effect in November 2010; well after many other countries demanded a Darvocet recall.