March 4, 2011
the FDA required the manufacturers of Topamax to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects including Cleft Lip, Cleft Palate,and genital malformations including Hypospadias which is a malformation of the penis in new born males.
A scientific study, published in Neurology in 2008,
established that taking Topamax significantly increases the risk of birth defects. The published study reviewed 203 pregnancies. Of these, 178 resulted in a live birth. Overall, the rate of oral clefts observed was 11 times more prevalent than the normal rate. Due to these and other serious side effects, the United States Food and Drug Administration (FDA) issued a warning for patients taking Topamax. The warning was raised to Category D, which means there is positive evidence of human fetal risk.
If it is proven that as a result of the manufacturer's failure to adequately research the risk associated with taking Topamax while pregnant or warn about the potential problems, people were injured, compensation may be available through a Topamax lawsuit for the families whose children have been harmed by this drug.