Austin, TX (PRWEB) April 6, 2011
Over 37% of Topamax (http://www.hkllp.com/topamax/) related adverse event reports involving toddlers indicate serious birth defects which may be linked to use of the drug, according to data provided by the FDA’s Adverse Event Report database. The FDA has warned that using Topamax during pregnancy increases the risk of certain birth defects by as much as 21 fold.
Topamax is an anti-epilepsy drug that has also been approved for the treatment of migraines. In March 2011, the FDA warned that women who use Topamax during pregnancy are 21-times more likely to give birth to a child with oral cleft palate and cleft lip defects than non-users.
The FDA’s own Adverse Event Database contains 244 unique Individual Safety Reports (ISRs) concerning Topamax users that cite a condition involving children less than 2 years or less than 44 pounds. At least 91 of these unique reports, or 37%, cite one or more serious birth defects (http://www.hkllp.com/topamax/topamax-birth-defects/) which the FDA has recently warned may be related to Topamax use.
The attached chart provides the incidence of serious birth defects which the FDA warned Topamax users compared to all Topamax adverse events reported. Cleft palate/lip represents almost 12% of all Topamax related adverse events involving toddlers. Heart defects including septal defects, ASD, VSD and cardiac perforations were reported in almost 9% of these unique adverse events.
To download the cited data obtained from the FDA’s Adverse Event Report database, visit: http://www.hkllp.com/wp-content/uploads/2011/04/FDA-AERs-for-Topamax-Toddlers.xls .
Based on these reports and other information about the link between Topamax and birth defects, the FDA added the drug to its Pregnancy Category D, meaning that it has a proven risk of causing birth defects.
In May 2010, two subsidiaries of Johnson & Johnson paid a criminal fine of $81.5 million for illegally marketing Topamax for off-label uses. As part of a settlement with the U.S. Department of Justice, the companies pled guilty to illegally promoting Topamax for psychiatric disorders, bipolar disorder, weight loss and alcohol and drug dependency.
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