Everolimus Under FDA Scrutiny For Potential Risk

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Everolimus has been added to FDA's Adverse Event Reporting System due to a possible risk of hypertension.


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

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Everolimus is prescribed to treat 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.

Link to the FDA website:

Link to the article on Medscape: