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Epilepsy, migraine drug linked to 2000 percent increase in birth defects

Tuesday, March 15, 2011 by: Ethan A. Huff, staff writer
Tags: birth defects, epilepsy, health news

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(NaturalNews) New data released by the US Food and Drug Administration (FDA) shows that mothers taking Johnson & Johnson's (J&J) Topamax, as well as its generic version topiramate, during pregnancy are 2000 percent more likely to bear children with oral defects like cleft lips or cleft palate than women who do not take the drug. While intended to be prescribed for epilepsy, Topamax is also prescribed for migraine headaches, which many pregnant women experience.

According to data collected from the North American Antiepileptic Drug Pregnancy Registry, roughly 1.4 percent of babies whose mothers took Topamax or a generic version of the same drug were born with birth defects, compared to a 0.07 percent rate in babies whose mothers did not take any such medication. Between 0.38 and 0.55 percent of babies born to mothers taking other types of epilepsy drugs developed birth defects.

Russell Katz, director of the FDA's Division of Neurology Products, made a statement warning doctors to be highly cautious when prescribing Topamax or its generic varieties, and instead pursue "alternative medications that have a lower risk of birth defects." The agency says stronger warning labels are needed to deter flagrant use of the drug.

J&J insists, however, that Topamax's warning label already contains adequate information about the "recommended cautious use (of the drug) in pregnant patients." The company raked in more than half a billion dollars in 2010 from Topamax sales alone.

Last summer, J&J settled a lawsuit involving the illegal marketing and branding of Topamax for uses other than that for which it was approved. The company hired doctors to work alongside drug sales representatives in convincing other doctors to prescribe Topamax for off-label uses (http://www.naturalnews.com/029301_Big_Pharma...).

Sources for this story include:

http://www.reuters.com/article/2011/03/04/us...

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