FDA News Briefs for Monday, December 3, 2018December 3, 2018
These Food and Drug Administration (FDA) developments came in late last week:
FDA Permits Marketing of Novel Diagnostic Test for CMV in Newborns
Last Friday, the FDA announced de novo classification clearance for the Alethia CMV Assay Test System (Meridian Bioscience Inc.) for use as an aid in detecting congenital cytomegalovirus (CMV) in newborns younger than 21 days of age. More Information.
FDA Clears New Indication for gammaCore Device
Last Wednesday, electroCore Inc. announced another FDA clearance for gammaCore, a prescription device that delivers noninvasive transcutaneous vagus nerve stimulation (nVNS). The device is now indicated for adjunctive use for the preventive treatment of cluster headache in adults. The FDA previously cleared gammaCore for the acute treatment of pain associated with cluster headache or migraine headache in adults. More Information.
FDA Warning: Watch for Differentiation Syndrome in Patients Taking Idhifa
The FDA issued an alert to emphasize the need for early recognition and aggressive management of differentiation syndrome in patients being treated with Idhifa (enasidenib, Celgene Corporation). Idhifa is an oral targeted therapy for adults with relapsed or refractory acute myeloid leukemia (AML) that is positive for an isocitrate dehydrogenase-2 (IDH2) mutation. The Idhifa label carries a boxed warning regarding risk of differentiation syndrome, but the FDA has learned that some cases of this potentially fatal side effect go undiagnosed, and patients are not receiving the necessary treatment. More Information.
FDA Adds New Warnings to Lemtrada Label
In a safety announcement issued last Thursday, the FDA reported that rare but serious cases of stroke and tears in the linings of head and neck arteries have occurred in patients with multiple sclerosis shortly after they received Lemtrada (alemtuzumab; Genzyme). These new warnings were added to the Lemtrada label. In addition, the risk of stroke was added to the existing boxed warning. More Information.
Class I Recall: BrightMatter Guide with SurfaceTrace Registration
Synaptive Medical is recalling its BrightMatter Guide System due to a defect found in the device’s software that could potentially result in serious or life-threatening patient harm. 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.
Class I Recall: Zimmer Biomet Recalls Spinal Fusion and Long Bone Stimulators
Zimmer Biomet Inc. is recalling its Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and SpF-XL Implantable Spinal Fusion Stimulator due to a lack of adequate validation and controls to ensure that these implants are clean and free from bacteria and chemical residue. The FDA has identified this action Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. More Information.