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.
NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval
However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting accelerated approval of drugs for noncirrhotic nonalcoholic steatohepatitis.
Panelists at a recent Duke-Margolis meeting cite growing use of native ads and patient influencers, as well as the limited attention given to presentation of risk information, in calling for a re-examination of how pharmaceutical promotion on digital platforms is regulated.