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FDA News Briefs for Wednesday, February 28, 2018

February 28, 2018

These Food and Drug Administration (FDA) developments came in this week:


Medtronic Recalls Some CRT-Ds and ICDs Due to Serious Manufacturing Error

Medtronic is recalling certain cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter-defibrillators (ICDs) due to a defect in the manufacturing process. This defect may prevent these devices from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. The FDA has identified this action as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. More Information.


Verzenio Now Indicated for First-Line Therapy

The FDA has expanded indications for Verzenio (abemaciclib; Eli Lilly and Company) to include first-line use in combination with an aromatase inhibitor for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Verzenio is an oral cyclin-dependent kinase 4 & 6 inhibitor. More Information.