In late January, Genentech sent letters to 1,500 eye specialists warning that trials of Lucentis (ranibizumab injection) showed a higher incidence of stroke, according to a report in The Wall Street Journal.

The ongoing 5,000-patient trial compares two doses of Lucentis: the recommended 0.5mg dose and a lower 0.3mg dose. An analysis of the trial showed that patients taking the higher dose had a 1.2% higher incidence of strokes, The Wall Street Journal reported.

Early results from the trial also show that patients who had a previous stroke appear to be at greater risk of another stroke.

Dawn Kalmar, a company spokesperson, told Reuters, We have shared this information with the FDA and there is no indication, based on our discussions with the agency, that this will change the label.

Another Genentch drug, Avastin (bevacizumab), is FDA-approved for colorectal cancer but is used off-label in the eye as a lower-cost alternative to Lucentis. In 2004, the company sent out a letter that warned of Avastins risk for serious and fatal arterial thromboembolic events.