As noted in the briefing (online at www.fda.gov), Topamax is an anti-epileptic medication that was originally approved for use in December 1996, and is made by Ortho McNeil Janssen (now Janssen Pharmaceuticals, a division of Johnson & Johnson). It is used in children to treat seizures, but in children aged one to 24 months, its usefulness at the time of the briefing was not established.
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). Furthermore, a warning was added about the risk of cleft lip and/or cleft palate when pregnant women used Topamax in March 2011.
“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,” the warning stated (online at www.fda.gov; 3/4/11). 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.
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Meanwhile, 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 US. There were also 581 reports of serious adverse events worldwide, with 245 of those in the US.