Tag: Update

AHFS Drug Information/Essentials Update – June 2016

The June update to the AHFS Drug Information/Essentials database was published today. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • Alirocumab (Praluent®)
    • Alirocumab is used as an adjunct to diet and maximally tolerated HMG-CoA reductase inhibitor (i.e., statin) therapy for the treatment of patients with heterozygous familial hypercholesterolemia or clinical ASCVD who require additional reduction in low-density lipoprotein (LDL)-cholesterol concentrations
  • Talimogene Laherparepvec (Imlygic®)
    • Talimogene laherparepvec is used intralesionally for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma following initial surgery
  • Elosulfase Alfa (Vimizim®)
    • Elosulfase alfa is used as replacement therapy in patients with mucopolysaccharidosis IVA (MPS IVA, Morquio A syndrome) and is designated an orphan drug by FDA for use in this condition.
  • Evolocumab (Repatha®)
    • Evolocumab is used as an adjunct to diet and maximally tolerated HMG-CoA reductase inhibitor (i.e., statin) therapy for the treatment of patients with heterozygous familial hypercholesterolemia or clinical ASCVD who require additional reduction in low-density lipoprotein (LDL)-cholesterol concentrations

FDA MedWatch Alerts

  • Fluoroquinolones
    • Serious adverse effects generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated UTIs
    • Affected monographs:
      • Moxifloxacin, ofloxacin, ciprofloxacin, levofloxacin, gemifloxacin
  • Ketoconazole
    • Avoid using oral tablets to treat skin and nail fungal infections
  • Canagliflozin
    • Increased risk of leg and foot amputations
  • Olanzapine
    • Rare but serious skin conditions

AHFS Patient Medication Information Update – May 2016

The May update to the AHFS Patient Medication Information (PMI) database has been published. Highlights of the update include:

New PMI Monographs:

  • Amphotericin B Liposomal Injection (AmBisome®)
    • Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis and visceral leishmaniasis
  • Dexamethasone Injection (Decadron® & Available generically)
    • Dexamethasone injection is used to treat severe allergic reactions, certain types of edema, gastrointestinal disease, and certain types of arthritis, and other diseases treated by corticosteroids
  • Reslizumab Injection (Cinqair®)
    • Reslizumab injection is used along with other medications to treat asthma

FDA MedWatch Alerts – Monograph Revisions

  • Aripiprazole
    • Warning regarding compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported
  • Ticagrelor and Vortioxetine
    • Brand name change for vortioxetine (Brintellix) due to name confusion with ticagrelor (Brilinta)
  • Olanzapine and Olanzapine injection
    • Rare, but serious skin reactions
  • Fluoroquinolones
    • Serious adverse effects generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated UTIs
    • Affected monographs:
      • Ciprofloxacin, ciprofloxacin injection, gemifloxacin, levofloxacin, levofloxacin injection, moxifloxacin, moxifloxacin injection, ofloxacin

AHFS Drug Information/Essentials Update – May 2016

The May update to the AHFS Drug Information/Essentials database was published today. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • Ganciclovir (Zirgan®)
    • The ophthalmic gel is indicated for the topical treatment of acute herpetic keratitis in patients with dendritic ulcers

FDA MedWatch Alerts

  • Metformin
    • Revised warnings in reduced kidney function
  • Fluconazole
    • FDA is evaluating the results of a Danish study that concluded there is a possible increased risk of miscarriage with the use of oral fluconazole for yeast infections
  • Aripiprazole
    • Warning regarding compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported
  • Ticagrelor and Vortioxetine
    • Brand name change for vortioxetine (Brintellix) due to name confusion with ticagrelor (Brilinta)
1 2 3