News: F.D.A. Pulls Painkiller Due to Risks

After almost 50 years, the FDA has decided to withdraw Darvon, a painkiller, from the American markets due to possible critical health effects.

The Associated Press reported on November 19th that Xanodyne Pharmaceuticals, the company that manufactured the drug, carried out a study last year and found out the drug can cause fatal arrhythmias. Darvon had been withdrawn from English and European markets in 2005 and 2009, respectively. The Public Citizen, a consumer overseer, had appealed to the US government in 1978 and in 2006 to extract the drug from the American markets. Companies producing the generic form were asked to stop marketing all drug forms containing the active component Darvon. Oxycodone and codeine, commonly prescribed drugs, may produce the same effect.

This action raises a couple of issues worth mentioning. It took the US government almost 30 years to act, even though there were reports of drug-related safety issues since 1978. The question is why the long lag period. Maybe research methodologies were not as rigorous as they are today; hence the results at the time seemed inconclusive. But 32 years is an awfully long time to wait for irrefutable results.

Another lag period stems from the time it took the US FDA to act after the withdrawal of the drug from UK and EU markets. I think I can accurately assume that previous studies had been carried out in UK and EU before they decided to pull the drug off their markets. So, why did the USA not consider such studies and instead, waited a whole year for results of a study sponsored by the manufacturing company, of which has inherent conflicts of interest?

On an ending note, I would like to ask how will drug regulatory agencies in developing countries react toward this recent action by the US FDA and also, will generic producing drug companies in developing countries pull their compounds off the markets?

No comments yet.

Leave a Reply

Designed & Developed by Web Ideations