The U.S. Food and Drug Administration today removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication manufactured by Genzyme Corporation (now Sanofi). The FDA first approved Caprelsa in 2011 to treat medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed. At the time, a REMS program was required to ensure appropriate heart rhythm monitoring and safe use. After over more than a decade of oversight, REMS assessments reported no cases of Torsades de pointes or unexplained sudden deaths among U.S. patients taking Caprelsa. Clinical data also showed no concerning patterns of heart rhythm problems. “Cancer specialists now have adequate knowledge about managing the heart rhythm related risks of this medication,” said Richard Pazdur, M.D., FDA Oncology Center of Excellence Director. “Health care providers have incorporated proper safety monitoring into their standard practice, making the formal requirements unnecessary. The mandatory monitoring program has achieved its goals.” Caprelsa will remain available with the same prescribing information, but health care providers will no longer need special certification or extra monitoring beyond standard clinical care. A REMS is a safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. The safety requirements for Caprelsa included mandatory training for health care providers and monitoring of patients.
Health care providers, pharmacies and patients with questions may contact the FDA at (855) 543-3784 or (301) 796-3400, or by email at [email protected].
Adverse events, medication errors or quality problems with Caprelsa should be reported to FDA's MedWatch Adverse Event Reporting program.
FDA's top priority is patient safety, and the agency will continue to monitor the safety of this medication. |
