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 taking the products are at increased risk for opportunistic infections. The announcement applies to Wyeth’s Rapamune (sirolimus), Roche’s CellCept (mycophenolate mofetil), Novartis’ Myfortic (mycophenolic acid), and Novartis’ cyclosporine drugs Sandimmune and Neoral, as well as generic versions of the products where applicable.

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The agency stated that the new labelling requirement is based on a review of adverse event reports about the treatments. The drugs’ warnings must be updated “to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy,” the FDA noted.

The regulator, which said that BK virus-associated nephropathy mainly affects patients who have had a kidney transplant, added that it is continuing its safety review of immunosuppressant drugs used for this procedure.

Source: FirstWord

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