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FDA Adds Drug Everolimus to its Adverse Reporting System

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

Everolimus is prescribed to address renal cell carcinoma in patients who have received unsuccessful treatments in the past.

About the FDA’s analysis of Everolimus

Besides adding everolimus to its Adverse Event Reporting System (FAERS), the FDA has not provided any additional information on the subject and (quote): “is continuing to evaluate this issue to determine the need for any regulatory action.”

It is important to note that listing a drug in the FAERs section of the FDA’s website does not mean that it is not suitable for prescription or that patients should stop using it. However, the FDA does recommend discussing any possible concerns with your healthcare provider and will provide a statement to the public once an investigation is completed.

In addition to its use for the treatment of renal cell carcinoma, the FDA has also approved everolimus as a treatment to prevent kidney transplant rejection.

Medscape reports that in a related clinical trial, the adverse event rate for hypertension was approximately 30%.

Adverse Events of Everolimus

The following adverse events have been reported in patients taking everolimus:

  • Pyrexia
  • Anemia
  • Renal failure
  • Fatigue
  • Respiratory failure
  • Renal damage
  • Infection
  • Gastrointestinal hemorrhage
  • Death

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