Dopamine Agonists: US FDA Orders Safety Labeling Changes But Not Boxed Warnings
Agency denies citizen petition requests for boxed warning on risk of impulse control behaviors and other psychiatric disorders with the class of drugs used to treat Parkinson’s disease and restless legs syndrome, but agrees with one petitioner that some safety-related changes are warranted.
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Consumer group's languishing petition seeks class-wide REMS on risk of impulse control adverse events, such pathological gambling, hypersexuality, compulsive shopping, and binge eating caused by dopamine agonists.
CDC’s advisory committee also approves a VFC program update allowing for the rare, off-label use of tetanus toxoid- and diphtheria toxoid-containing vaccine in young children, and plans to move up timing of its COVID-19 vaccine recommendations for the 2024-2025 formulation.
However, David Kaslow, director of the FDA’s vaccines office, says only a ‘may’ recommendation is supported and that giving an extra dose after June ‘may not be optimal’ if vaccines are reformulated for the fall.