Dhivy (carbidopa/levodopa) / Alora Pharma - LARVOL DELTA

FDA mandates label updates to common Parkinson's meds based on seizure risk finding (Fierce Pharma) - "Healthcare providers should evaluate patients’ baseline vitamin B6 levels prior to and during treatment and supplement patients with the vitamin as necessary, the warning says....The label update affects Amneal’s Crexont and Rytary; Avion Pharmaceuticals’ Dhivy; Merck’s Sinemet and controlled-release Sinemet CR; Novartis’ Stalevo; and AbbVie’s Duopa. Also affected is AbbVie’s newer Vyalev, a subcutaneous treatment that delivers prodrugs of carbidopa and levodopa via an infusion pump system....In its safety review, the FDA identified 14 causes of seizures linked to vitamin B6 deficiency in patients taking the common Parkinson’s disease drugs, including 13 instances that were submitted to the FDA’s adverse events reporting system and 1 reported in medical literature."

Adverse events • FDA event • Parkinson's Disease