EVEROLIMUS MAY CAUSE HYPERTENSION

The US Food and Drug Administration (FDA) has added everolimus (Zortress, Novartis) to its FDA Adverse Event Reporting System (FAERS) because of new safety information the agency has received regarding hypertension.

Everolimus is prescribed to treat renal cell carcinoma in patients who have failed previous treatments.

However, the FDA has not released any additional information and "is continuing to evaluate this issue to determine the need for any regulatory action." The signals the agency has received relate to pulmonary hypertension and pulmonary arterial hypertension.

Listing of a drug in FAERS on the FDA's website does not mean the drug should not be prescribed or that patients should stop taking it. The FDA advises discussing any concerns with healthcare providers. The agency will follow up with comment for the public once an investigation is done.

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 Zortress website.