Wednesday, December 22, 2010

Pfizer, Health Canada pull Thelin from shelves

From the Globe and Mail:
Health Canada and drug giant Pfizer formally announced Monday the company is taking a drug used to treat a rare, but serious, lung disease off the market due to risks of potentially fatal liver damage.

Pfizer Canada also said the company is abandoning all clinical trials of sitaxsentan sodium, better known by the brand name Thelin, and removing the drug from every country where it is sold.

The decision is raising questions about why the drug, used to treat pulmonary hypertension, was approved in Canada in the first place.

Parent company Pfizer Inc. announced more than a week ago its intentions to pull the drug off the market in Canada, Australia and Europe, as well as halt clinical trials. The decision was prompted by the deaths of three patients involved in clinical trials of the drug.

The company was conducting the trials in a bid to get the U.S. Food and Drug Administration to approve the drug in that country. ...more

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