Darvon: Pulled from the Market in 2011

Darvon, generic name propoxyphene, is no longer.  Several months ago, the FDA pulled it from the market.  Some have called propoxyphene the worst drug in history.  Read more to see why:

Physicians Say Good Riddance to 'Worst Drug in History'

February 2, 2011 — An estimated 10 million patients have used the pain reliever propoxyphene and were sent scrambling o doctors' offices when it was recently pulled from the market. Many physicians are still dealing with the aftermath of the product, first approved by the US Food and Drug Administration (FDA) in 1957.

Propoxyphene is the worst drug in history," Ulf Jonasson, doctor of public health, from the Nordic School in Gothenburg, Sweden, told Medscape Medical News. The researcher played a role in the decision to stop the pain reliever in the United Kingdom, Sweden, and later in the entire European Union.

No single drug has ever caused so many deaths," Dr. Jonasson said.

Propoxyphene was banned in the United Kingdom 5 years ago because of its risk for suicide. It was taken off the market in Europe in 2009 over concerns about fatal overdoses and now in the United States for arrhythmias.

"I agree that propoxyphene is among the worst drugs in history," Eduardo Fraifeld, MD, president of the American Academy of Pain Medicine, said in an interview. "I'm surprised it stayed on the market so long. It's addictive, in my experience not very effective, and toxic."

"I'd probably add Demerol to the list too," Dr. Fraifeld said. "It's toxic and sedating, and my personal opinion is it should not be used at all."

Also known as pethidine, Demerol was the first synthetic opioid synthesized in 1932 as a possible antispasmodic agent. Its analgesic properties were recognized later. For much of the 20th century, pethidine has been the opioid of choice for many physicians treating acute and chronic severe pain.

"The writing has been on the wall for both of these drugs," Dr. Fraifeld said. "With adverse events, prescription abuse increasing, and questionable effectiveness, this isn't innocuous."

A growing number of products are entering the US market, Dr. Fraifeld noted. "It's unrealistic to expect regulators to be able to closely track every single one." Prescribers and patients must therefore pay close attention to any emerging side effects, he said. "Unfortunately, clinicians are not using adverse event reporting systems adequately," Dr. Fraifeld added.

I think it's fair to say that many physicians have no idea how to even use the system, and this is a problem." Propoxyphene was first developed by Eli Lilly and later sold to Xanodyne Pharmaceuticals, which marketed the drug under the brand names Darvon and Darvocet.

Since 1978, the FDA has received 2 requests to remove propoxyphene from the market. In January 2009, an advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects. The information is in.  Propoxyphene causes fatal heart rhythms.

Source:  Medscape February 2011

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