Family Medicine News Alerts

• Alert FDA OKs Midazolam Nasal Spray (Nayzilam) for Seizure Clusters Nayzilam is the first FDA-approved nasal option for treating seizure clusters that are distinct from a patient's usual seizure pattern in patients aged 12 years or older.
  FDA Approvals, May 2019
• Alert EU Panel Backs Market Withdrawal of Fenspiride Due to Heart Risk The European Medicines Agency's Pharmacovigilance Risk Assessment Committee recommended revoking marketing authorizations for fenspiride medicines, preventing them from being marketed in the EU.
  News Alerts, May 2019
• Alert EMA Puts Temporary Restrictions on Tofacitinib Due to PE Risk The EMA's safety committee advises physicians not to prescribe the 10-mg twice-daily dose of tofacitinib to patients who are at high risk for pulmonary embolism, pending results of an ongoing safety review.
  News Alerts, May 2019
• Alert FDA OKs Teduglutide for Children With Short Bowel Syndrome Teduglutide is the only glucagon-like peptide-2 analog approved that improves intestinal absorption in patients with short bowel syndrome who are dependent on parenteral support.
  FDA Approvals, May 2019
• Alert European Commission OKs Dupilumab for Severe Asthma Dupilumab is for patients with moderate-to-severe asthma and increased blood eosinophil and/or raised fractional exhaled nitric oxide levels poorly controlled with other medicines.
  International Approvals, May 2019
• Alert FDA Approves First Vaccine for Dengue, With Restrictions Dengvaxia is for the prevention of dengue disease caused by all dengue virus serotypes in people aged 9 to 16 years who have previously had laboratory-confirmed dengue infection and who live in endemic areas.
  FDA Approvals, May 2019
• Alert European Commission Approves Risankizumab for Plaque Psoriasis In clinical studies, patients with moderate to severe plaque psoriasis saw significantly higher rates of skin clearance with risankizumab compared to current standards of care.
  International Approvals, May 2019
• Alert FDA Approves Two-Drug Combo Mavyret for HCV in Adolescents The FDA approved glecaprevir and pibrentasvir (Mavyret, AbbVie) tablets for the treatment of all six hepatitis C virus (HCV) genotypes in children ages 12 to 17 years.
  FDA Approvals, April 2019
• Alert FDA OKs Second Etanercept Biosimilar for Inflammatory Diseases Etanercept-ykro (Eticovo) is approved across all eligible indications for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis.
  FDA Approvals, April 2019
• Alert FDA Adds Boxed Warning to Insomnia Drugs The FDA has added a boxed warning to insomnia drugs, highlighting the risk of serious injury and death caused by sleepwalking, sleep driving, and engaging in other activities while not fully awake.
  News Alerts, April 2019
• Alert EMA Panel Backs Triple Therapy Inhaler for COPD Temybric Ellipta combines fluticasone furoate, umeclidinium, and vilanterol in a single inhaler and is for maintenance treatment of moderate-to-severe COPD.
  International Approvals, April 2019
• Alert EU Panel Backs Dolutegravir/Lamivudine Combo Pill for HIV Dovato contains 50 mg dolutegravir and 300 mg lamivudine and would be the first once-daily, single-pill, completed 2-drug regimen for treatment of HIV in Europe.
  International Approvals, April 2019
• Alert EU Panel Recommends Hydroxycarbamide for Sickle Cell Disease An EMA committee recommended marketing authorization for hydroxycarbamide for the prevention of vaso-occlusive complications of sickle cell disease in patients older than 2 years.
  International Approvals, April 2019
• Alert FDA OKs First Treatment for Pediatric Lupus Belimumab (Benlysta) intravenous infusion, already approved in adults, may now be used in children aged 5 years and older with active SLE.
  FDA Approvals, April 2019
• Alert FDA OKs New Topical Treatment Duobrii for Plaque Psoriasis Duobrii lotion is the first and only topical lotion that combines halobetasol propionate and tazarotene in one formulation.
  FDA Approvals, April 2019
• Alert EMA Panel Backs Long-Lasting Implant for Opioid Dependence Sixmo consists of four small rods implanted in the upper arm that continuously deliver low levels of buprenorphine for 6 months with promises of boosting adherence to treatment.
  News Alerts, April 2019
• Alert FDA Approves TransPyloric Shuttle Intragastric Device for Obesity The endoscopically delivered intragastric device provides another option for patients who are obese but ineligible, or unwilling, to have bariatric surgery, and has advantages over intragastric balloons.
  FDA Approvals, April 2019
• Alert Mislabeled Fentanyl Patches Spark Nationwide Recall Two lots of transdermal patches from the Fentanyl Transdermal System for pain management are being voluntarily recalled by the manufacturer because of product mislabeling.
  News Alerts, April 2019
• Alert FDA Clears First Device for Treating ADHD The US Food and Drug Administration has granted marketing authorization for the Monarch external trigeminal nerve stimulation system to treat ADHD in patients between the ages of 7 and 12 years.
  FDA Approvals, April 2019
• Alert FDA Okays First Generic Naloxone Nasal Spray for Opioid Overdose The FDA has granted final approval for the first generic naloxone hydrochloride nasal spray for reversing or stopping the effects from an opioid overdose.
  FDA Approvals, April 2019