Drugs

Petition Asks Warnings for RLS Drugs

BioMedEcon is asking FDA to require labeling changes for manufacturers of dopamine agonists used to treat restless leg syndrome including risks of serious mental disorder reactions. The petition specifically cites Mirapex (pramipexole), Requip (ropinirole HCl), and Neupro (rotigotine). The agency is asked to:

require addition of a Boxed Warning to the three products advising of the risk for development of new onset and exacerbation of existing mental disorders;
require that manufacturers of the three products amend current product labeling to provide specific amplification of the risk to restless leg syndrome patients for adverse mental disorder reactions;
require manufacturers of the three drugs to revise the current Medication Guide to more appropriately reflect the risk of serious adverse mental disorder events induced by dopamine agonist treatment for restless leg syndrome; and
require the manufacturers to issue and disseminate Dear Healthcare Provider drug warning letters apprising them of the labeling changes.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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