Posts Tagged ‘ Thelin ’

Score One for the FDA as Rest of World Finally Yanks Thelin

January 3rd, 2011. By Hunter West

Time to give credit where credit is due. And this time, the US Food and Drug Administration (FDA) got it right. 

Recently it was announced, in a joint statement by Health Canada and Pfizer Canada, that Thelin (sitaxsentan) was being taken off the market in Canada, as well as every country in which it had been sold, due to risk for potentially fatal liver damage. 

Never heard of Thelin? There’s a reason for that. Thelin is not available in the US. Never was. That’s because the FDA refused to approve the drug designed to treat pulmonary hypertension. In the view of the FDA, the benefits did not outweigh the risks. 

In a bid to win FDA approval for marketing Thelin in this country, Pfizer Inc. launched a series of clinical trials. However, those trials have been abandoned following the deaths of three trial participants. 

According to a report in the Globe and Mail, Canada’s national newspaper, liver damage was a known complication of Thelin. However, in announcing that it was abandoning further clinical trials, Pfizer noted that it had discovered a  “new potentially life-threatening idiosyncratic risk” of liver injury among patients that is difficult to predict or guard against. 

Thus, there will be no further clinical trials, and Thelin will be coming off the market in Australia, Europe and Canada where it had been previously approved. Given the known risks associated with Thelin, Canadians are wondering how Thelin ever won Health Canada approval in the first place. 

The FDA has been maligned, chastised, ridiculed and kicked to the curb over the appearance of lax oversight both in the approval, and ongoing supervision of drugs and medical devices. And to be sure, much of that criticism is warranted. 

However, on this occasion the FDA stuck to its guns and has been vindicated. There can be Read the rest of this entry »

Tags: FDA, Pfizer, Thelin
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