The FDA on Tuesday alerted healthcare professionals that it is requiring the manufacturers of certain immunosuppressant drugs to update warning labels to include that patients Read the full story

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The FDA issued an alert to healthcare professionals on Thursday regarding Wyeth’s kidney-transplant drug Rapamune (sirolimus). The agency noted that trial data provided by the company “suggest increased mortality in stable liver transplant patients” who switched to the drug from calcineurin inhibitor-based immunosuppressive therapy.

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Wyeth submitted data from the trial to the FDA in March, and spokesman Doug Petkus stated that the company will provide final results by the end of July. The FDA explained that it is considering whether changes should be made to the drug’s label, which already carries a boxed warning advising against use immediately after liver transplantation.

Petkus said the results were first released at a medical conference last year and he added that Wyeth “will continue to work with the FDA on this matter to incorporate this information into the label so that physicians are informed of the company’s research to date.” Rapamune is indicated in the US for the prevention of organ rejection in patients aged 13 years or older who are receiving kidney transplants, and the product had global sales of $376 million in 2008.

Source: FirstWord

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