Darvon Darvocet and Death
Much has been made lately of the Food and Drug Administration’s authority on the marketing and sale of pharmaceutical drugs. These powers were expanded dramatically in 2007, but were only recently put into practice with the withdrawal of a certain type of painkillers from American shelves. In other words, the FDA had been granted broad new regulatory powers, but only put them into practice this year. In the interim, several dangerous drugs were allowed to stay on the market, despite being banned in other countries and despite being broadly suspected of being harmful to the patients who used them. This makes us wonder what the FDA was waiting for.
The first drug that the FDA actually did something about was a painkiller called Darvon, and its generic equivalent Darvocet. It wasn’t exactly new information that something was wrong with it. This painkiller has been on the market since 1957. Its main ingredient is an opioid called propoxyphene, which is meant to handle light to moderate pain. So while it certainly isn’t nearly as addictive as OxyContin or Vicodin, the dangers with propoxyphene-based drugs lie elsewhere.
The main problem is that propoxyphene appears to cause damage to the heart. There have been several studies that lead to that conclusion. In fact, the FDA had already recalled the drug twice since 1978. Both recalls were essentially negated when the FDA failed to find anything conclusive. The regulatory agencies of the United Kingdom and the European Union had no such difficulties in seeing the problem, and banned Darvon and Darvocet in 2005 and 2009, respectively. The FDA only got around to banning Darvocet and Darvon in November of 2010.
While the FDA dithered and failed to use its new powers, literally millions of people were still being prescribed propoxyphene based drugs. This makes the case of Kira Nicole Gilbert particularly tragic. Ms. Gilbert was a 22 year old Cincinnati-area woman who injured her knee while working at an orphanage in April of 2009. Her doctor prescribed her Darvocet for the pain. Eight days later she was found dead in her apartment. The autopsy ruled that cause of death was acute cardiac failure combined with pulmonary edema, which is a medical term for a buildup of fluid in the lungs. Ms. Gilbert was the picture of perfect health prior to her knee injury, and while the pharmaceutical company would be hard pressed to find some other cause for her death, we imagine that won’t stop them from trying.
Ms. Gilbert’s death happened long after the Food and Drug Administration suspected that there was something wrong with propoxyphene, and long after the FDA had the power to move faster to remove dangerous drugs from the shelves of American pharmacies and hospitals. Such behavior is practically expected of pharmaceutical companies, who will go to very great lengths to keep their products on the shelves regardless of the dangers to the people who use them. But regulatory agencies are meant to protect the general public from harm. In the case of Darvon and Darvocet, the FDA acted too late.
When the FDA finally removed these drugs from the shelves, they concluded that Darvon, Darvocet and other propoxyphene-based drugs can cause significant changes in the electrical activity of the heart, even when it is used in small therapeutic doses. This alteration of electrical activity can cause heart palpitations, irregular heartbeats and episodes of cardiac arrest.
Greenberg and Bederman is currently offering legal assistance to people in Maryland, Virginia or Washington, D.C. who have been injured and hospitalized due to the use of painkillers containing propoxyphene. We are also offering help to the families of people who have lost their lives due to the use of Darvon and Darvocet. If you or a loved one has suffered from a heart attack, heart palpitations, pulmonary edema or other health complications after taking Darvon or Darvocet, contact Greenberg and Bederman for a free drug injury legal consultation.
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