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FDA News Briefs for Wednesday, May 8, 2019

May 8, 2019

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


FDA Approves Drug for Pediatric LEMS

The FDA has approved Ruzurgi (amifampridine; Jacobus Pharmaceutical Company Inc.) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in children aged 6 to < 17 years. This is the second amifampridine formulation to be FDA-approved; in November 2018, the FDA approved Firdapse (amifampridine phosphate; Catalyst Pharmaceuticals Inc.) for the treatment of LEMS in adults. More Information.


Safety Alert: Medtronic Pacemakers and CRT-P Devices

The FDA has alerted providers and patients regarding issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected without warning patients or health care providers. The FDA is aware of 3 medical device reports in which a Medtronic implantable pacemaker or CRT-P battery had fully drained because of a crack in the device’s capacitor, without any warning to the patient or health care provider. If a capacitor in an implanted pacemaker or CRT-P is cracked, it can create an electric short, which can cause a battery to drain earlier than expected. If the battery is completely drained, the device will no longer deliver pacing therapy. The patients who rely heavily on pacing or who are pacemaker dependent may be most at risk for having an adverse outcome. More Information.