Drugs

FDA Denies Most of 2 Dopamine Agonist Petitions

FDA has denied all requests in a Public Citizen 6/29/16 petition involving dopamine agonists and most requests in a BioMedEcon 6/2/17 petition involving certain specific dopamine agonists.

Public Citizen had asked that FDA (1) add a Boxed Warning to labeling for all dopamine agonists describing the risk of developing certain impulse-control problems and compulsive behaviors, and (2) establish a risk evaluation and mitigation strategy (REMS) for the drugs that includes a Dear Healthcare Provider letter and a Medication Guide.

BioMedEcon asked that FDA require manufacturers of dopamine agonists approved to treat moderate-to-severe restless leg syndrome (RLS) to (1) include a Boxed Warning for development of new onset and exacerbation of existing mental disorders; (2) amend the Warnings and Precautions and Adverse Reactions sections of labeling to give specific amplification of the risk to RLS patients for adverse mental disorder reactions; (3) revise the current Medication Guide to more appropriately reflect the risk of serious adverse mental disorder events induced by dopamine agonist treatment for RLS; and (4) issue and disseminate Dear Healthcare Provider letters about the labeling changes.

FDA denied all requests in both petitions except to grant the BioMedEcon petition to the extent that the agency has determined that there is new safety information that should be included in the labeling for some of the dopamine agonists and is notifying specific manufacturers about labeling changes to be made.

The FDA response reviews current labeling for all the products and the comprehensive review the agency undertook to evaluate the petitions’ requests. It says it did not find most of the requests to be justified by the evidence it reviewed.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome