Family Medicine News Alerts

• Alert FDA Clears Mobile App for Opioid Use Disorder The prescription-only reSET-O application is intended for use in conjunction with outpatient therapy to treat opioid use disorder.
  FDA Approvals, December 2018
• 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 EC Clears Two New HIV Drugs (Pifeltro and Delstrigo) Pifeltro contains doravirine, a new nonnucleoside reverse transcriptase inhibitor, and Delstrigo is a fixed-dose combination of doravirine, lamivudine, and tenofovir disoproxil fumarate.
  International Approvals, November 2018
• Alert Three Common Dementia Screens Faulty, Inaccurate Three widely used brief cognitive assessment tests appear to be faulty and often yield false negative or false positive results.
  News Alerts, November 2018
• Alert FDA Warns About Serious Adverse Effect of AML Drug Enasidenib A life-threatening adverse effect called differentiation syndrome is not being recognized in patients receiving the acute myeloid leukemia drug enasidenib, says the FDA.
  News Alerts, 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 EC OKs Gene Therapy Luxturna for Inherited Retinal Dystrophy
  International Approvals, 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 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 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 FDA Approves New Drug for Traveler's Diarrhea (Aemcolo) Aemcolo (rifamycin) is indicated to treat adults with travelers' diarrhea caused by noninvasive strains of E. coli and not complicated by fever or blood in the stool.
  FDA Approvals, November 2018
• Alert EMA Curtails Use of Fluoroquinolone, Quinolone Antibiotics The occurrence of disabling and potentially permanent side effects associated with quinolone and fluoroquinolone antibiotics has led the European Medicines Agency (EMA) to restrict or suspend their use.
  News Alerts, November 2018
• Alert FDA OKs Revefenacin (Yupelri) for COPD Revefenacin, a long-acting muscarinic antagonist, is the first once-daily nebulized bronchodilator approved for chronic obstructive pulmonary disease (COPD) in the US.
  FDA Approvals, November 2018
• Alert FDA Clears First Ebola Fingerstick Test With Portable Reader The DPP Ebola Antigen System is the second Ebola rapid antigen fingerstick test granted emergency use authorization and the first that uses a portable battery-operated reader.
  FDA Approvals, November 2018
• Alert FDA Reintroduces OTC Primatene Mist for Mild Asthma Primatene Mist is for the temporary relief of mild symptoms of intermittent physician-diagnosed asthma in patients 12 years and older. Some medical societies are pushing back on the decision, though.
  FDA Approvals, November 2018
• Alert FDA Panel Backs Novel Treatment for Postpartum Depression Vote was nearly unanimous that the benefits of brexanolone outweigh risks, but only when used within a strict Risk Evaluation and Mitigation Strategies (REMS) program.
  FDA Approvals, 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