Public Citizen Sues US FDA To Get Boxed Warning On Dopamine Agonists For Compulsive Behaviors
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.
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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.
Opioids: FDA Actions May Silence Call For Moratorium On Approvals
Citizen petition seeks review of all marketed opioids; agency is considering whether new opioids should have comparative benefit over existing drugs.
FDA Denies Petition To Pull Teething From OTC Benzocaine Label, Expects Voluntary Changes By Marketers
FDA denies Public Citizen's petition for rulemaking to remove infant teething as an indication for OTC benzocaine and require a contraindication on labels advising against using gel and liquid products for teething pain. The agency has asked marketers for voluntary label changes and says a rulemaking would be too lengthy, but Public Citizen says a rulemaking started when the problem became known would already be completed.