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
