Genentech will inform physicians of a warning on hemolytic anemia in Raptiva (efalizumab) labeling, stemming from the company's postmarketing surveillance of the plaque psoriasis therapy.

During a second quarter earnings call July 11, Genentech said it will issue a "Dear Healthcare Provider" letter advising physicians of the updated label.

"Reports of hemolytic anemia, some serious, diagnosed 4-6 months after the start of Raptiva treatment, have been received. Raptiva should be discontinued if hemolytic anemia occurs," the warning states.

FDA approved the updated labeling June 10.

Genentech said two cases of severe hemolytic anemia were reported in the postmarketing setting and that the causal relationship to Raptiva therapy is unknown.

"Genentech actively monitors the safety of our products in the postmarketing setting, and we are committed to keeping prescribers and the FDA informed of any new important safety information in a timely manner," Product Development President Susan Hellmann said.

The Raptiva label also has been updated to include a precaution on serious arthritis events, Genentech said.

The precaution states: "Infrequent new onset or recurrent severe arthritis events, including psoriatic arthritis, have been reported in clinical trials and postmarketing. These arthritis events began while on treatment or following discontinuation of Raptiva and were uncommonly associated with a flare of psoriasis."

"Patients improved after discontinuation of Raptiva with or without anti-arthritis therapy," the label adds.

FDA approved Raptiva in 2003 for treatment of adults with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

- Jessica Merrill

Genentech Will Alert Physicians To Raptiva Anemia Warning

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