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LAWSUITS NEWS & LEGAL INFORMATION

Darvon and Darvocet Pulled from Market After 53 Years

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Washington, DCThe US Food and Drug Administration (FDA) announced late last week that it requested the removal of two pain medications from the market due to the potential for negative impact on heart rhythms. CNN reported Friday that the manufacturers of Darvon and Darvocet agreed to remove the two prescription meds from the market, at the urging of the FDA.

The FDA also urged the makers of generic versions of the two drugs to pull them from the market as well.

"We recommend to physicians stop prescribing the drugs," said Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology. "As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay."

Propoxyphene (Darvon) has been on the market for more than 50 years. First approved by the FDA in 1957, the opioid drug used to treat mild to moderate pain has been the subject of controversy in the past. CNN reports that since 1978, the FDA has received two requests to remove the pain medication from the market. However, in both cases the FDA determined the benefits outweighed the risks.

That all changed this year, after the FDA reviewed the results of a clinical study that raised increasing concern over heart risks.

Propoxyphene is sold as Darvocet when combined with acetaminophen.

Xanodyne Pharmaceuticals Inc. is the manufacturer of the Darvon and Darvocet brands—two drugs that have been prescribed (including generics) to 10 million people since 2009.

"The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," the FDA said in a statement released Friday.

READ ABOUT DRUG REMOVAL LAWSUITS

READER COMMENTS

Posted by

on
An excellent decision from the FDA because it allows demonstrate that are pending medications that cause damage to our agency. Findrxonline on their website mentions this as an important article by decisions FDA shows with these prohibitions of prescription drugs.

Posted by

on
I had been prescribed Darvocet/Darvon for a couple of years to help with chronic back issues. I started feeling 'funny' breathless and sort of nervous and didn't attribute it to the medication at first. Then one day it was really scary - I was at work and started feeling like I couldn't catch my breath. I called my doctor and they called right back and told me NOT to take any more - I sure didn't. When I went in to see him, he said that perhaps I had become allergic after taking it for awhile. Didn't matter to me because I never took another one. Scary stuff!!!

Posted by

on
I have had Darvocet prescribed to me for the last 10 or more years. No problems that I know of but I am a prime candidate. I still have about 75 tablets out of 200 left. Will try not to take any more as of today!

Posted by

on
The FDA’s decision to order Darvon and other propoxyphene-containing products removed from the market on November 19, 2010, comes 5 YEARS after the pain reliever had been banned in Great Britain and a YEAR AND A HALF after it was withdrawn by all other members of the European Union. While other countries were taking strong regulatory steps to protect their citizens, the FDA’s reaction had been to simply increase the warnings on its risks. Darvon and its sister drugs have had a long history of drug addiction, suicide and cardiac problems since first entering the market in 1957. My question is this – why should it take 53 years to determine that a drug should not be on the market?

This history is not unique. On October 8, 2010, the FDA announced that Abbott Laboratories would be withdrawing Meridia from the American market, 9 months after the weight-loss drug was removed by the European Union. Earlier, the FDA had only strengthened the warning on the drug’s labeling, cautioning its users about the risk of heart attacks and strokes. On September 23, 2010, the FDA decided to allow Avandia to remain on the market, while the European Medicines Agency decided to pull the plug on the drug in Europe. These decisions are somewhat reminiscent of the history involving the drug, Cylert, which was withdrawn by the FDA in 2005 because it was causing severe liver damage to children taking it for ADHD – eight years after it was withdrawn by Great Britain.

This pattern of increasing warnings while other countries are removing drugs that do not belong on the market is only a small sample of why our FDA and its oversight of drugs is no longer the gold standard of the world. Meanwhile, thousands of Americans are dying unnecessarily. As many as 230,000 per year die in the United States as a result of an adverse reaction to prescription and/or nonprescription drugs – a number that can be cut in half.

Changes need to be made and they need to happen now. And it has got to start by eliminating the insanity of drug companies conducting their own premarket studies rather than an impartial entity, such as the National Institutes of Health. For everyone who is in agreement with taking some action, I would urge you to go to the website, www.FDAreformpetition.com and sign my petition to Congress demanding a change. Only if the citizens of this country speak in a strong and unified voice will we catch the attention of Congress and impress upon it the need for such a change.

Posted by

on
The FDA’s decision to order Darvon and other propoxyphene-containing products removed from the market on November 19, 2010, comes 5 YEARS after the pain reliever had been banned in Great Britain and a YEAR AND A HALF after it was withdrawn by all other members of the European Union. While other countries were taking strong regulatory steps to protect their citizens, the FDA’s reaction had been to simply increase the warnings on its risks. Darvon and its sister drugs have had a long history of drug addiction, suicide and cardiac problems since first entering the market in 1957. My question is this – why should it take 53 years to determine that a drug should not be on the market?

This history is not unique. On October 8, 2010, the FDA announced that Abbott Laboratories would be withdrawing Meridia from the American market, 9 months after the weight-loss drug was removed by the European Union. Earlier, the FDA had only strengthened the warning on the drug’s labeling, cautioning its users about the risk of heart attacks and strokes. On September 23, 2010, the FDA decided to allow Avandia to remain on the market, while the European Medicines Agency decided to pull the plug on the drug in Europe. These decisions are somewhat reminiscent of the history involving the drug, Cylert, which was withdrawn by the FDA in 2005 because it was causing severe liver damage to children taking it for ADHD – eight years after it was withdrawn by Great Britain.

This pattern of increasing warnings while other countries are removing drugs that do not belong on the market is only a small sample of why our FDA and its oversight of drugs is no longer the gold standard of the world. Meanwhile, thousands of Americans are dying unnecessarily. As many as 230,000 per year die in the United States as a result of an adverse reaction to prescription and/or nonprescription drugs – a number that can be cut in half. Changes need to be made and they need to happen now. And it has got to start by eliminating the insanity of drug companies conducting their own premarket studies rather than an impartial entity, such as the National Institutes of Health. For everyone who is in agreement with taking some action, I would urge you to go to the website, www.FDAreformpetition.com and sign my petition to Congress demanding a change. Only if the citizens of this country speak in a strong and unified voice will we catch the attention of Congress and impress upon it the need for such a change.

Posted by

on
Will I have more side effects already had open heart and valve replacement and because I didn't take heavy duty pain relief took darvocet I just don't know what to think.

Posted by

on
I have been prescribed Darvocet for pain, as I cannot tolerate many stronger meds, and many others such as nsaids are unfriendly to my only, my transplanted kidney.

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