NCHR Testimony to FDA on Victoza for to Prevent Cardiovascular Events

June 20, 2017. In summary, there are questions relating the LEADER trial that raises questions about its generalizability. With only one study, however large, we don’t even know if the results would be replicated. The LEADER study suggests that the drug does not significantly increase cardiovascular risk. However, the sponsor has not demonstrated that it reduces cardiovascular risk, especially not for U.S. patients whose BMI, diet, and exercise habits might be quite different from those in other countries.

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NCHR Public Comments at the FDA’s Safe Use Symposium: A Focus on Outpatient Preventable Adverse Drug Effects

Bottom line: An important way for the FDA to help prevent adverse drug events is to make sure that patients know in advance what kind of choices they have for prescription drugs, and which ones are likely to be safer for them as women, people of color, patients over 65, and people with a particular illness. Patients deserve to know this information before filling their prescription.

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