Family Medicine News Alerts

• Alert FDA OKs Triclabendazole for Tropical Disease Fascioliasis Fascioliasis (liver fluke infestation) is a waterborne and foodborne neglected tropical disease affecting an estimated 2.4 million people worldwide, with an additional 180 million at risk.
  FDA Approvals, February 2019
• Alert EU Panel Recommends Fenspiride Suspension Because of Heart Risks The potential risk of serious heart rhythm problems associated with fenspiride prompts the EMA's safety committee to recommend suspending its use pending further review.
  Medscape Medical News, February 2019
• Alert FDA Panels Endorse Ketamine Spray for Resistant Depression Two FDA panels jointly recommended esketamine 28-mg single-use nasal spray for the patients with treatment-resistant depression.
  News Alerts, February 2019
• Alert FDA Cracks Down on Illegal Sale of Alzheimer's 'Cures' The FDA has sent warning letters to companies illegally marketing more than 58 products claiming to prevent, treat, or cure Alzheimer's disease and other serious conditions.
  News Alerts, February 2019
• Alert FDA OKs First Targeted Therapy for Rare Blood Clotting Disorder Caplacizumab (Cablivi) injection is indicated in combination with plasma exchange and immunosuppressive therapy for adults with acquired thrombotic thrombocytopenic purpura (aTTP).
  FDA Approvals, February 2019
• Alert Trump Tackles Drug Costs, HIV, Abortion in State of the Union Republicans and Democrats in Congress have already been targeting drug prices, but almost assuredly won't approve an abortion ban.
  Medscape Medical News, February 2019
• Alert ACIP Releases 2019 Child and Teen Vaccine Schedule FluMist for influenza returns as an option this year, although the American Academy of Pediatrics still prefers that kids get the shot. Homelessness is added as an indication for hepatitis A vaccination.
  Medscape Medical News, February 2019
• Alert Abuse-Deterrent OxyContin Tied to Spike in Hepatitis C The introduction of abuse-deterrent OxyContin may be a factor in the sharp rise in hepatitis C infections in the United States because drug abusers switched to injectable heroin, research suggests.
  News Alerts, February 2019
• Alert EU Panel Recommends Humira Biosimilars Idacio, Kromeya The EMA's Committee for Medicinal Products for Human Use has recommended marketing authorization for two biosimilars that are highly similar to Humira (adalimumab, AbbVie).
  International Approvals, February 2019
• Alert FDA Approves First Generic of Advair Diskus The Mylan generic comes in three strengths and is indicated for twice-daily treatment of asthma in patients as young as age 4 and for adults with COPD.
  FDA Approvals, January 2019
• Alert Intensive BP Lowering Cuts MCI Risk: Results Published Aggressively lowering systolic blood pressure cuts the risk for mild cognitive impairment in newly published results from the SPRINT MIND trial. However, questions remain about dementia risk.
  News Alerts, January 2019
• Alert FDA Clears First Diagnostic Test for Mycoplasma genitalium The Aptima nucleic acid amplification test detects Mycoplasma genitalium in urine, urethral, penile meatal, endocervical, and vaginal swab samples collected in a clinical setting.
  News Alerts, January 2019
• Alert FDA Moves to Fast-Track OTC Naloxone for Opioid Overdose The agency announced 'unprecedented' steps to jump-start development of over-the-counter (OTC) naloxone to help reduce opioid overdose deaths.
  News Alerts, January 2019
• Alert FDA Clears First Generic Version of Seizure Drug Sabril Generic vigabatrin is indicated as add-on therapy for the treatment of complex partial seizures in patients aged 10 and older who are refractory to several other treatments.
  FDA Approvals, January 2019
• Alert FDA Clears Epilepsy Smartwatch for Use in Children The Embrace smartband detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers.
  FDA Approvals, January 2019
• Alert Sanofi's Pediatric Hexavalent Vaccine Approved by U.S. FDA The U.S. Food and Drug Administration approved Sanofi's new pediatric vaccine immunizing children against six diseases, the French pharmaceutical lab said on Wednesday.
  Reuters Health Information, December 2018
• Alert FDA Clears Test to Analyze Nutrients in Breast Milk The Miris Human Milk Analyzer can help clinicians make nutritional decisions for newborns and young infants at risk for growth failure due to prematurity or other medical conditions.
  FDA Approvals, December 2018
• Alert U.S. FDA Approves New Protocol for Study on Bayer's Essure Birth Control Device The U.S. Food and Drug Administration on Thursday approved a new protocol for a post-marketing study of Bayer AG's Essure birth-control device, as the regulator seeks more information on the device's safety.
  Reuters Health Information, December 2018
• Alert FDA Warns Genetech Over Unapproved Stem-Cell Products Twelve patients who received Genetech's unapproved products subsequently became ill from blood infections and other infections caused by a number of bacteria, including E coli.
  News Alerts, December 2018
• Alert FDA OKs Prucalopride (Motegrity) for Chronic Idiopathic Constipation Prucalopride, a selective serotonin-4 (5-HT4) receptor agonist, enhances bowel motility by stimulating colonic peristalsis.
  FDA Approvals, December 2018