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Drug Safety Oversight Board Meeting, September 20, 2012

Public Summary

The following are Drug Safety Communications (DSC) posted since the July 19, 2012 meeting and relayed to the Drug Safety Oversight Board (DSB or Board) via memorandum:

  • July 23, 2012: Ampyra (dalfampridine): A DSC concerning the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine) was posted. Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures.
  • August 15, 2012: Codeine: A DSC regarding reports of deaths in post-tonsillectomy pediatric patients who are ultra-rapid metabolizers of CYP2D6 was posted. A publication in the journal Pediatrics (Volume 129, Number 5, May 2012) reported 3 deaths in children taking codeine after tonsillectomy for obstructive sleep apnea.
  • August 30, 2012: Revatio (sildenafil): A DSC notifying the public that Revatio (sildenafil) not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension regarding a recommendation against use of Revatio in children with pulmonary hypertension.
  • September 13, 2012: Over the counter topical muscle and joint pain relievers: A DSC notifying the public of rare cases of serious burns with the use of over-the-counter (OTC) topical muscle and joint pain relievers. These OTC topical pain relievers are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin. The various formulations include creams, lotions, ointments, and patches.
  • September 19, 2012: Mirapex (pramipexole): A DSC was posted informing the public about a possible increased risk of heart failure with Mirapex (pramipexole), a drug used to treat Parkinson’s disease and restless legs syndrome. Results of recent studies suggest a potential risk of heart failure that needs further review of available data.

To open the meeting, Dr. Woodcock provided a CDER update to the Drug Safety Oversight Board.

The DSB discussed two topics:

  1. Update on feedback received on drug product registries
  2. MedWatch practice portal

Update to the Drug Safety Oversight Board

Janet Woodcock, MD, Director of CDER, provided a CDER update to the DSB concerning the FDA Innovation and Safety Act (FDASIA), the legislation passed in July 2012. She discussed the Prescription Drug User Fee Act (PDUFA) reauthorization, the new Generic Drug User Fee Act (GDUFA) and Biosimilar User Fee Act (BsUFA). Dr. Woodcock also discussed the new provision for Breakthrough Therapies and highlighted REMS commitments in the PDUFA reauthorization.

Update on drug product registries

Dr. Lehrfeld, from the Office of Surveillance and Epidemiology/Division of Risk Management (DRISK) presented an update to the Board, focusing on the feedback the federal partners provided to DRISK concerning drug product registries.

MedWatch Practice Portal

Staff from FDA’s Office of Special Health Issues gave a presentation of an education project aimed at training health professional students, as well as the public, in completing MedWatch forms for submission to FDA.