Neurology News Alerts

• Alert FDA Okays Wearable Device for Opioid Withdrawal The FDA has cleared an auricular neurostimulation device to help reduce symptoms of opioid withdrawal, including cravings, agitation, anxiety, and depression.
  FDA Approvals, June 2018
• Alert FDA Clears Gamified Neurorehabilitation System MindMotion GO is a computer-based mobile neurorehabilitation system for patients with light- and medium-severity neurological impairments.
  FDA Approvals, June 2018
• Alert CHMP Recommends Approval for Inotersen in hATTR Inotersen has won recommendation of the EMA's Committee for Medicinal Products for Human Use for treatment of hereditary transthyretin amyloidosis.
  International Approvals, June 2018
• Alert Safety Concerns Trigger Naloxone Hydrochloride Recall The possible presence of embedded or loose particulate matter on the syringe plunger has triggered a voluntary recall of two lots of naloxone hydrochloride injection.
  News Alerts, June 2018
• Alert CHMP Advises Against Approval for Eteplirsen in DMD The EMA's Committee for Medicinal Products for Human Use recommends against approval of eteplirsen for Duchenne muscular dystrophy but extends approval of ataluren to younger patients with the disease.
  International Approvals, June 2018
• Alert EU Panel Endorses Erenumab for Migraine Prevention An expert panel of the European Medicines Agency has recommended granting marketing authorization for erenumab, the first human monoclonal antibody for migraine prevention.
  International Approvals, June 2018
• Alert FDA Okays Robotic System to Detect Abnormal Brain Blood Flow The FDA has cleared a new ultrasound technology that could help physicians diagnose, triage and manage patients who present with vasospasm, acute ischemic stroke, and other neurologic disorders characterized by abnormal blood flow in the brain.
  FDA Approvals, May 2018
• Alert Congress Passes Right-to-Try Bill ASCO, NCCN, and other medical groups remain opposed to the legislation passed by the House today, citing potential harms to patients.
  Medscape Medical News, May 2018
• Alert FDA Warns Kratom Makers Over Illegal Sales, Deceptive Marketing The FDA continues its crackdown on 'unscrupulous vendors' of unapproved products containing kratom, especially those making unproven medical claims.
  Medscape Medical News, May 2018
• Alert FDA Clears Next-Gen Stroke Stent Retriever EmboTrap II The EmboTrap II retriever showed favorable rates of reperfusion, high rates of successful removal of the clot on the first attempt, and good clinical outcomes in the ARISE II study.
  FDA Approvals, May 2018
• Alert US, EU Warn About Birth Defect Risk From Dolutegravir The FDA and EMA have warned about a possible increased risk for neural tube defects in infants born to women who take dolutegravir for HIV during pregnancy.
  News Alerts, May 2018
• Alert FDA Approves First-in-Class Drug for Migraine Prevention The human monoclonal antibody erenumab has become the first anti-calcitonin-gene-related peptide (CGRP) treatment to receive FDA approval for the prevention of migraine.
  FDA Approvals, May 2018
• Alert FDA Approves First Nonopioid Drug for Opioid Withdrawal Lofexidine reduces symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keeps patients from successfully withdrawing from opioids.
  Medscape Medical News, May 2018
• Alert FDA Okays Fingolimod (Gilenya), First Treatment for Pediatric MS The FDA has expanded approval of the oral agent fingolimod from treatment for adults to treatment for children and adolescents aged 10 and up with multiple sclerosis.
  Medscape Medical News, May 2018
• Alert FDA Issues Recommendations on Stents for Unruptured Aneurysm Neurovascular stents used for stent-assisted coiling of unruptured aneurysms have been linked to reports of periprocedural stroke and death, prompting the new recommendations, the agency said.
  News Alerts, May 2018
• Alert Mosquito and Tick Diseases a Large and Growing Threat in US Illnesses from mosquito, tick, and flea bites have tripled in the US over the past 13 years, and better ways to fight this growing public health threat are needed, federal health officials say.
  Medscape Medical News, May 2018
• Alert Sufentanil Hybrid Gets Nod in EU for Moderate to Severe Pain The new product, Dzuveo, is similar to another sufentanil-containing pain reliever that has been available in the European Union since 1978.
  International Approvals, April 2018
• Alert FDA: Lamotrigine Tied to Rare, Serious Immune System Reaction The FDA will add a warning about the risk for hemophagocytic lymphohistiocytosis to the prescribing information on lamotrigine drug labels.
  News Alerts, April 2018
• Alert FDA Alert on MR-Guided Laser Interstitial Thermal Therapy Devices The agency says there is a risk of tissue overheating because of inaccurate magnetic resonance (MR) thermometry with MR-guided laser interstitial thermal therapy devices.
  News Alerts, April 2018
• Alert FDA Clears Everolimus Tablets for Seizures in Tuberous Sclerosis Everolimus tablets for oral suspension become the first approved therapy specifically indicated for the treatment of partial-onset seizures associated with tuberous sclerosis complex.
  FDA Approvals, April 2018