FDAnews Drug Daily Bulletin

MEDWATCH ALERT ISSUED ON AMEVIVE

Nov. 21, 2005
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Biogen Idec's psoriasis treatment Amevive may cause complications in patients with HIV, according to a recent MedWatch alert.

The FDA warned that Amevive (alefacept) should not be administered to patients infected with HIV because the drug "reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease in these patients." Biogen Idec recently issued a "Dear Healthcare Provider" letter to alert physicians that Amevive's product labeling has changed to reflect the contraindication. "This contraindication is consistent with the company decision not to study Amevive in HIV positive psoriatic patients due to the theoretical safety concern in this patient population," the letter states.

Amevive is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

To view Biogen's letter, go to http://www.fda.gov/medwatch/safety/2005/Amevive_final_letter.pdf (http://www.fda.gov/medwatch/safety/2005/Amevive_final_letter.pdf).