Warning of Lucentis stroke risk issued
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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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
