Posts Tagged ‘FDA’
Mass Torts Update - Thursday, May 2, 2013 9:52 - 0 Comments
It has been more than 18 months since the U.S. Food and Drug Administration (FDA) convened a pediatric advisory committee meeting to discuss Topamax side effects in pediatric patients. Information provided prior to the panel discussion showed that Topamax side effects in children, while not fully studied, had the potential to be quite serious, including reports of death in the briefing information. Because the panel was only discussing the use of Topamax in pediatric patients, it wasn’t focusing on the risk of Topamax side effects in infants exposed to the medication prior to birth.
Topamax, made by Ortho McNeil Janssen (now Janssen Pharmaceuticals, a division of Johnson & Johnson), is an anti-epileptic medication that was originally approved for use in December 1996. It is used in children to treat seizures, but in children aged 1 to 24 months, its usefulness at the time of the briefing was not established. You can get the briefing online at www.fda.gov.
A Risk Evaluation and Mitigation Strategy (REMS) was approved in April 2009 and updated in March 2011 to warn about suicidal ideation in some patients who used Topamax, known generically as topiramate. A warning was added about the risk of cleft lip and/or cleft palate when pregnant women used Topamax in March 2011. The warning stated:
The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.
Topiramate is in FDA pregnancy category D because of evidence of human fetal risk based on human studies. It has not been removed from the market because some women may find the risks acceptable in certain circumstances. According to the briefing information, children aged 0 to 16 years accounted for 7 percent of total Topamax use from April 2007 through March 2011, with approximately 2.1 million prescriptions written for 315,000 patients. Of those, almost 9,000 patients were less than 1 year old, more than 65,000 patients were between the ages of 2 and 9, and 255,000 patients were aged 10 to 16. The majority of pediatric uses for Topamax were epilepsy, migraines, headaches and convulsions, although Topamax is not approved to treat headache and migraine in children.
Of the 1,124 reports of adverse events worldwide involving Topamax in pediatric patients from 1996 to March 2011, 83 reports involved death, with 30 of those being in the U.S. There were also 581 reports of serious adverse events worldwide, with 245 of those in the U.S. It seems pretty clear that Topamax use for children needs further scrutiny.
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