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Topamax Adverse Event Reports Detail 100+ Birth Defects

Apr 29, 2011 | Parker Waichman LLP

More details are emerging about the types of birth defects that might be associated with the antiepileptic drug Topamax (topiramate).  According to the U.S. Food & Drug Administration's (FDA) Adverse Event Report database, there have been a total of 244 reports made to the agency of injuries to children believed to be associated with the use of Topamax.   Of those, more than 100 involved possible Topamax birth defects.

Topamax is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topamax is also approved for use to prevent migraine headaches, and is also sometimes used off-label to treat bipolar disorder.  Earlier this year, the FDA moved Topamax from Pregnancy Category C to Pregnancy Category D, meaning that there is positive evidence of human fetal risk based on human data.  The FDA chose to change the pregnancy category for Topamax after Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicated that infants exposed to Topamax as a single therapy during the first trimester of pregnancy experienced higher prevalence of oral clefts.

Approximately 47 percent - 114 total -  of reported Topamax injuries in children involve birth defects, according to the FDA.  These reports included 29 oral clefts, 29 limb malformations, 27 heart defects, 26 reports of other congenital defects, 23 cranio-facial defects, 15 reports of spina bifida/spinal malformations, and 5 reports of persistent pulmonary hypertension of the newborn (PPHN).   There were also 47 reports made to the registry detailing other problems, such as premature birth, developmental delay, and low birth weight in children whose mothers took Topamax during pregnancy.

When the FDA changed the Topamax pregnancy category in March, it   advised doctors to weigh the benefits and risks of Topamax when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Women of childbearing age who take Topamax should also be advised to use effective contraceptives, the agency said.


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