Drug Safety Labeling Changes: June 2024
Caduet, Cimerli, Acuvail, Eprontia, Nicotrol
Caduet
Blood pressure drug Caduet (amlodipine besylate; atorvastatin calcium) had a drug safety label update to emphasize increased risk of liver injury. Liver enzyme testing should be considered before atorvastatin initiation and when clinically indicated thereafter.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1118
Cimerli
Opthamalic drug Cimerli (RANIBIZUMAB-EQRN) had a drug safety label update to warn of the risk of retinal vasculitis (retinal swelling) with or without occlusion (blockage of retinal artery). Also, it is noted that the safety and effectiveness of CIMERLI in pediatric patients have not been established. Cimerli is used to treat (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularization (mCNV).
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2960
Acuvail
Opthamalic drug Acuvail (ketorolac tromethamine solution/drops) had a drug safety label update to warn of the risk of contamination of the vial tip, allergic reactions, and exacerbation of asthma. Acuvail is used to treat pain after cataract surgery.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2961
Eprontia
Epilepsy and migraine drug Eprontia (Topiramate) had a safety label update to add to the section on potential fetal harm when the drug is taken by a pregnant woman. The label was also updated to add that the drug is now approved for use in pediatric patients age 2 and up as an adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2689
Nicotrol
Smoking cessation drug Nicotrol (Nicotine) had a drug safety label update to warn of the risk of dysphagia (difficulty swallowing), chest pain, anaphylactic reactions, and seizures. This update is for both the nasal spray and inhaler formulations of Nicotrol.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2040 (nasal spray)