Neurology News Alerts

• Alert FDA OKs Vagus Nerve Stimulator to Prevent Cluster Headaches The FDA has expanded the label for the gammaCore vagus nerve stimulator to include adjunctive use in the prevention of cluster headache in adults.
  FDA Approvals, December 2018
• Alert FDA OKs First Treatment for Lambert-Eaton Myasthenic Syndrome Amifampridine (Firdapse) is approved for adults with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder characterized by muscle weakness.
  FDA Approvals, November 2018
• Alert Unpleasant Surprises With Blood Pressure Drug for PTSD Contrary to expectations, bedtime dosing of prazosin may worsen nightmares and insomnia, and the drug does not reduce suicidal ideation, new findings suggest.
  News Alerts, November 2018
• Alert Neuronavigation System Recalled Due to Brain Damage Risk A software defect in the BrightMatter Guide system could result in serious or life-threatening harm, prompting the company to issue a recall. The FDA has labeled it a Class I recall, the most serious type.
  News Alerts, November 2018
• Alert Teva Recalls All Amlodipine/Valsartan Combination Products in US In the ongoing saga of tainted sartans, Teva recalls all amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination products because of contamination with NDEA.
  News Alerts, November 2018
• Alert FDA Warns of High Levels of Heavy Metals in Kratom FDA scientists have found heavy metals including lead and nickel at levels not considered safe for human consumption in some kratom products.
  News Alerts, November 2018
• Alert Mylan Recalls 15 Lots of Valsartan Products in US The Mylan recall of valsartan tablets, amlodipine/valsartan tablets, and valsartan/hydrochlorothiazide tablets marks the latest recall of sartans contaminated with probable carcinogens.
  News Alerts, November 2018
• Alert FDA Warns Sellers of Illegal Tianeptine Supplements Jack B Goods Outlet Store and MA Labs receive warning letters from the FDA for marketing diet supplements containing the unapproved antidepressant tianeptine for opioid addiction, pain, and anxiety.
  Medscape Medical News, November 2018
• Alert FDA Warns of MS Worsening After Stopping Fingolimod (Gilenya) The agency adds a new warning to the fingolimod label and patient medication guide about this risk, which can lead to permanent disability.
  News Alerts, November 2018
• Alert ER Doctor, Pharmacist Among Dead in Chicago Hospital Shooting Doctors unite in mourning on Twitter and vent at the NRA, using #ThisIsOurLane.
  Medscape Medical News, November 2018
• Alert FDA Grants Oleic Acid Qualified Heart Health Claim Olive oil and other oils that contain at least 70% oleic acid will be able to claim possible heart benefits on their labeling.
  FDA Approvals, November 2018
• Alert FDA OKs Gamifant, First Drug for Rare Immune Disease HLH Emapalumab is an interferon gamma-blocking antibody that fills an unmet medical need for patients with primary hemophagocytic lymphohistiocytosis, the FDA says.
  FDA Approvals, November 2018
• Alert Another Tainted 'Sartan' Recalled for Impurity Sandoz, along with FDA, has recalled one lot of losartan potassium hydrochlorothiazide tablets because of the presence of the probable human carcinogen NDEA.
  News Alerts, November 2018
• Alert EMA Panel Backs First Oral-Only Drug for Deadly Disease Fexinidazole is for the treatment of human African trypanosomiasis caused by Trypanosoma brucei gambiense in adults and children aged 6 years and older.
  International Approvals, November 2018
• Alert FDA Warns Against Using Unapproved Meds in Implanted Pain Pumps The FDA alerts physicians over the risk for complications when using medications that are not approved for use an implanted intrathecal pump.
  News Alerts, November 2018
• Alert FDA Goes Ahead With Approval of Sufentanil Despite Controversy The FDA's approval of sufentanil, a highly potent opioid for severe acute pain in adults in certified medically supervised healthcare settings, causes controversy with claims that the vote was rigged.
  FDA Approvals, November 2018
• Alert FDA Clears Clobazam Oral Film (Sympazan) for Lennox-Gastaut The FDA has approved an oral film formulation of clobazam for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and older.
  FDA Approvals, November 2018
• Alert FDA Panel Fails to Support Novel Opioid for Depression An FDA advisory panel failed to endorse the approval of a novel opioid to treat major depressive disorder because of insufficient efficacy data.
  News Alerts, November 2018
• Alert Medicare Plans to Phase in Changes for Office-Visit Payments CMS delays the start of a controversial E&M payment change but remains committed to collapsing what's now a five-level coding system.
  Medscape Medical News, November 2018
• Alert Common Household Chemicals Tied to Language Delays in Kids In children born to women who were exposed to phthalates during pregnancy, the rate of language delay is evident as early as age 30 months, a new study shows.
  News Alerts, October 2018