Anticonvulsant drugs used in pregnancy boost risk of birth defects
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The United States Food and Drug Administration issued a statement March 4 to warn doctors and patients that Women using topamax or otherwise known as topiramate including its generic counterparts during pregnancy were more likely to have babies with the birth defects cleft lip and cleft palate.
Topamax is indicated to treat certain types of seizures in individuals with epilepsy and prevent but not relieve migraine headaches. The FDA said doctors and nurses should warn patients of childbearing age about the risk.
"Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Dr. Russell Katz of the FDA's Center for Drug Evaluation and Research.
"Alternative medications that have a lower risk of birth defects should be considered."
Data from the North American Antiepileptic Drug Pregnancy Registry showed women who took topiramate during the first trimester of pregnancy were at increased risk of having babies with oral clefts.
To be exact, of infants exposed to topiramate during a single therapy, 1.4 percent should develop oral clefts. This is compared to 0.38 to 0.55 percent in those exposed to other anticonvulsant medications.
The prevalence of oral clefts in babies exposed to anticonvulsant drugs was awfully higher as the risk for those who were not exposed was merely 0.07 percent. In other words, exposure to the drugs increased the risk by a factor of up to 20 times.
Data from the United Kingdom Epilepsy and Pregnancy Register also showed the same pattern as what were observed in the U.S. database.
Because of this risk, the FDA said a stronger warning will be required to be placed on the prescription drug information.
However, the FDA insisted that the potential benefits of topiramate in pregnant women may outweigh the risks in some cases. Early the agency designated the medication as Pregnancy Category C because of the lack of human data, which did not stop the agency from approving the medication.
Using anticonvulsant drugs in pregnancy has been linked to low IQ in children and the drugs also boost risk of committing suicide.
Drug companies are not liable for any injury caused by medications approved by the FDA as long as the drugs are manufactured in accordance with the approved procedures.
David Liu
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