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Darvon Medication Should Have Been Banned Sooner: Critics

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Toronto, OntarioCritics of the Canadian health regulator note that Health Canada waited until the US Food and Drug Administration (FDA) urged the expulsion of Darvon and Darvocet from the US market before reacting north of the Canada/US border.

However, the FDA is not without its critics. When the FDA decided to pull the trigger on Darvon and Darvocet (which is Darvon in combination with acetaminophen), the move came 18 months after the entire European Union pulled Darvon, and a full five years after the British health authority in the UK banned it.

Thus, Health Canada appears to simply have played a game of "follow the leader" in this instance.

Recent published research, according to the December 3 issue of the Globe and Mail, linked Darvon-N to abnormal heart rhythms. However, concerns about Darvon and Darvocet side effects have been in the air for decades—making even the UK move to ban the drug five years ago appear as a somewhat slow arrival to the table.

Joel Lexchin, a professor in the School of Health Policy and Management at York University in Toronto, is pointed in his comments with regard to Darvon (Propoxyphene).
"This drug should have been off the market 30 years ago,"
Dr. Lexchin said in comments to the Globe and Mail December 2. "Unfortunately, it took this long to get it off the market."

Professor Lexchin was critical of Health Canada's 'follow-the-leader' stance, exposing in his view major shortcomings and weaknesses in the agency's drug-monitoring capabilities.

Darvon medication has been on the market since 1957. Darvocet, which combined Propoxyphene with acetaminophen, appeared sometime after that. And even though the research that prompted this action on Darvon and Darvocet is fairly recent, concern stems back to 1978. Consumer advocacy groups such as Public Citizen have been railing for years about this not-so-dynamic duo—especially in view of the fact Darvon and Darvocet were among the most commonly prescribed meds for the treatment of moderate pain.

This latest action involving a Darvon recall serves to fuel critics of drug regulators who feel the FDA should mandate more safety studies prior to approving a drug. It is also noted that the FDA remains powerless to ban a dangerous drug on its own. The agency's mandate is limited to pressuring a manufacturer to comply with a recall request.

Dr. Lexchin, in Toronto, notes that the Darvon and Darvocet issue suggests that other older, seemingly safe drugs may not be so innocuous.

"Just because they've been on the market for 40 years...doesn't mean they don't have potentially serious side effects," Dr. Lexchin said. "If we don't look for them, we're never going to find them."

Darvocet overdose is always a concern with a drug classified as a narcotic, which is what Darvocet is. Darvon, similarly, is classified as a narcotic.

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READER COMMENTS

Posted by

on
If one takes this medicine as prescribed, one should be okay. It is the missuse of the drug that perhaps might cause ill side effects. According to my doctor of many years, these medicines are safe if taken by a sensible person in the manner in which they are presecribed. Do not punish everyone just because some lobbyist for some other drug company is bent on denying help for those whose need for this painkiller is more than that of a stronger medication. Aspirin is also dangerous as is acetomenifin and other drugs if consumed by people who should not take them. Oxycontin is the most dangerous drug that can be taken, as far as I am concerned, but I do not see anyone taking it off the market and it is being prescribed by many anesthesiologistws/turned pain doctors.

Posted by

on
The FDA is NO doubt being paid off by drug Co's.
Too many drugs on the market.
Many of the drugs taken off the market,I was taking at one point in time, Darvocet, Celebrex and others.
Another one that should be taken OFF the market is Chantix, That is one Bad drug!!

They say the benefits out weigh the risks...Tell that to the Family who lost a member because of that drug.
This is nothing but Greed.

Posted by

on
I agree that the side effects are potentially hazardous and at times fatal, but there are no alternative drugs available in the same range of effectiveness for those who are allergic to opiates. This is a TERRIBLE call on part of the FDA and the manufacturer. All drugs have side effects and most are fatal if taken in large doses. This is a MISTAKE.

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