White Oak, OHCritics of manufacturer Xanodyne and its decision to pull Darvon and Darvocet from the market last November claim that due to the extent of Darvon side effects and their grievous nature, the recall came 30 years too late. The plaintiffs in a pending Darvon lawsuit could not agree more.
February 14 would have proved to be an unhappy Valentine's Day for Tammy and John Gilbert. According to The Cincinnati Enquirer on that day, this is the second Valentine's Day that the Gilberts have been unable to celebrate with their daughter after she died from heart failure in April of 2009.
She was only 22 when she died.
A knee injury their daughter had suffered resulted in what was considered at the time a routine prescription for Darvocet for pain. The victim's parents claim to have read the insert and the prescription bottle for any risks. What they found led them to believe the drug was safe.
However, it has since been discovered that Darvon medication was not safe, and hasn't been from the very beginning.
According to the Enquirer, Darvon manufacturer Xanodyne Pharmaceuticals Inc. voluntarily initiated a Darvon recall in November of last year after its own clinical trials clearly demonstrated that the risks outweighed the benefits. However, it is alleged that the risk (together with a suspicion of risk) had been an issue for decades, but prior to 2007 the US Food and Drug Administration (FDA) was powerless to mandate the monitoring of drugs once they were on the market.
The agency's new powers resulted in a request to Darvon propoxyphene manufacturer Xanodyne to conduct new clinical studies. The resulting studies clearly showed an indisputable risk, and the drugs were withdrawn. To that end, the FDA requested that all drugs containing propoxyphene be withdrawn.
The move mirrors a similar withdrawal in the UK in 2005.
Kira Nicole Gilbert was an only child. After suffering a torn ligament in her knee, the honors student was prescribed Darvocet for pain. She took the painkiller as prescribed. Even considering her youth, and the fact there was no history of heart conditions, Kira was found dead in her apartment eight days after beginning her prescription. The 22-year-old died of acute cardiac failure with evidence of pulmonary edema, which is an accumulation of fluid in her lungs.
Her parents filed a Darvocet lawsuit January 7 in US District Court in Cincinnati.
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