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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