GENENTECH WARNS DOCTORS OF INCREASED STROKE RISK WITH LUCENTIS

Genentech warned healthcare providers in a letter that use of eye drug Lucentis may increase the risk of stroke, particularly in patients who have already experienced a stroke.

According to the letter, which the company issued last month, preliminary data from a clinical trial showed that 1.2 percent of patients given a high dose of Lucentis (ranibizumab) had a stroke, compared with 0.3 percent of those treated with a low dose of 0.3 mg. The high dose, which has 0.5 mg per injection, is the one Genentech markets, the company said.

Patients in the study who had previously experienced a stroke had a higher risk of a subsequent stroke, the letter said.

The clinical study followed patients for an average of 230 days after starting treatment, the company said. The study will continue following patients and should be completed by the end of this year, Genentech added.

Lucentis treats wet age-related macular degeneration, one of the leading causes of blindness in people over the age of 55, according to Genentech. The drug is the first treatment to restore eyesight instead of slow deterioration, Genentech said.

The differences between the doses did not seem to affect the rates of heart attacks and vascular death, the company said. Overall, the study results seemed consistent with Phase III studies included in Lucentis' labeling and prescribing information, according to the letter.