FDA Questions Safety of Everolimus
The FDA added everolimus to its Adverse Event Reporting System due to new safety information the agency has received regarding hypertension. Everolimus is indicated for the treatment of renal cell carcinoma in patients who have failed previous treatments.
The FDA has not released any additional information on this decision and "is continuing to evaluate this issue to determine the need for any regulatory action." The addition to the Adverse Event Reporting System relate to pulmonary hypertension and pulmonary arterial hypertension.
Listing of a drug in the Adverse Event Reporting System on the FDA's Web site does not mean the drug should not be prescribed or that patients should stop taking it. The agency will follow-up with comment for the public once an investigation is complete.
The FDA has also approved everolimus as a treatment to prevent kidney transplant rejection. In a related clinical trial, the incidence rate for hypertension as an adverse event came to about 30%, according to the drug’s manufacturer.—Kerri Fitzgerald
