Warning of Lucentis stroke risk issued

February 5, 2007

According to a letter issued to healthcare providers by Genentech, maker of ranibizumab (Lucentis), use of the therapy may be associated with an increased risk of stroke, especially in patients who have previously had a stroke. Clinical trial data, collected after following patients an average of 230 days after starting treatment, showed a 1.2% incidence of stroke in patients given a 0.5-mg injection of ranibizumab compared with a 0.3% incidence for those receiving a 0.3-mg injection. The letter said the risk was higher for patients in the study who had already had a stroke. Ranibizumab is approved for treating wet age-related macular degeneration.

According to a letter issued to healthcare providers by Genentech, maker of ranibizumab (Lucentis), use of the therapy may be associated with an increased risk of stroke, especially in patients who have previously had a stroke. Clinical trial data, collected after following patients an average of 230 days after starting treatment, showed a 1.2% incidence of stroke in patients given a 0.5-mg injection of ranibizumab compared with a 0.3% incidence for those receiving a 0.3-mg injection. The letter said the risk was higher for patients in the study who had already had a stroke. Ranibizumab is approved for treating wet age-related macular degeneration.

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