Category Archives: Neurology

Onfi clobazam Drug Safety Communication

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Onfi (clobazam): Drug Safety Communication – Risk of Serious Skin Reactions AUDIENCE: Neurology, Pharmacy, Dermatology ISSUE: FDA is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm … Continue reading

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Gilenya fingolimod Drug Safety Communication

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Gilenya (fingolimod) – Drug Safety Communication: Investigating Rare Brain Infection AUDIENCE: Neurology, Pharmacy ISSUE: FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking … Continue reading

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Benztropine Mesylate Injection Nexus Pharmaceuticals Recall

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Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall – Visible Particulate Matter AUDIENCE: Pharmacy, Neurology ISSUE: Nexus Pharmaceuticals Inc. is recalling two lots of Benztropine Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the presence of … Continue reading

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Medtronic DBS NDE Kits Class 1 Recall

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Medtronic: Class 1 Recall – Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit AUDIENCE: Neurology, Nursing, Risk Manager, Surgery ISSUE: Medtronic sent an Urgent Medical Device Correction letter to all affected customers notifying them of the potential … Continue reading

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Valproate Anti-Seizure Products Drug Safety Communication

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Valproate Anti-Seizure Products: Drug Safety Communication – Contraindicated for Pregnant Women for Prevention of Migraine Headaches Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics AUDIENCE: Health Professional, Neurology, … Continue reading

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Potiga Ezogabine Drug Safety Communication

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Potiga (Ezogabine): Drug Safety Communication – Linked To Retinal Abnormalities And Blue Skin Discoloration AUDIENCE: Health Professional, Neurology, Patient ISSUE: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized … Continue reading

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Ad-Tech Macro Micro Subdural Electrodes Recall

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Ad-Tech Macro Micro Subdural Electrodes Audience: Risk Manager, Biomedical Engineering, Neurosurgery ISSUE: FDA and Ad-Tech notified healthcare professionals of a Class 1 recall due to concern the microelectrodes are defective and may cause injury to the brain. These devices are … Continue reading

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Vycor Viewsite Brain Access System VBAS Class 1 Recall

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Vycor Viewsite Brain Access System (VBAS): Class 1 Recall – Unidentified Fiber Found on Device     AUDIENCE: Neurology, Surgery, Risk Managers ISSUE: Vycor Medical recalled its VBAS because an unidentified black fiber was found on the device. This product … Continue reading

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Medtronic Drug Infusion Pumps Recall

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  Medtronic Drug Infusion Pumps: Recall – Intermittent or Permanent Pump Motor Stall ┬áSynchroMed II ImplantableSynchroMed EL Implantable Audience: Risk Manager, Physical Medicine, Neurosurgery ISSUE: FDA and Medtronic notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump … Continue reading

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Xyrem sodium oxybate Drug Safety Communication

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Xyrem (sodium oxybate): Drug Safety Communication – Warning Against Use With Alcohol or Drugs Causing Respiratory Depression AUDIENCE: Neurology, Internal Medicine, Patient ISSUE: FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or … Continue reading

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