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Topamax as a Dangerous Drug?: FDA Warns of Possible Birth Defect Risk

Following new data indicating that babies born to women who were pregnant when Topamax are at higher risk of developing a cleft palate, the U.S. Food and Drug Administration has decided to strengthen the warning labels that come with the drug. Topamax?s generic equivalents will also get new labels. If you think there is a possibility that your child may have developed a birth defect or another serious health injury or issue from taking Topamax, you should contact our Charlotte, North Carolina dangerous drug law firm right away.

Per the new data, from the North American Antiepileptic Drug Pregnancy Registry, topiramate, which is the main ingredient in Topamax, can increase the risk of oral clefts in babies during the first trimester of a woman?s pregnancy by more than 20 times.

Other possible serious side effects:

? Other types of craniofacial defects affecting the oral cavity
? Genital birth defects
? Limb malformation
? Greater risk of spina bifida
? Persistent pulmonary hypertension
? Hypospadias
? Genital birth defects
? Congenital birth defects

Johnson & Johnson (JNJ) is the parent company of Ortho-McNeil Pharmaceutical LLC, which makes this anti-seizure/anti-migraine drug. It was just last year that two subsidiaries of Johnson & Johnson consented to paying over $81 million to settle claims by the Justice Department that they had illegally marketed Topamax to facilitate weight loss and treat bipolar disorder, alcohol dependency, and other off-label conditions that the FDA had not yet approved. A number of whistleblower complaints had also been filed accusing doctors of receiving payments to push Topamax for off-label purposes.

The FDA wants doctors and other medical professionals to make sure that they warn women of childbearing age about the risks associated with taking Topamax when prescribing it.

UPDATE: FDA Strengthens Topamax Warning On Evidence Of Birth Defects, The Wall Street Journal, March 4, 2011

Moms-to-Be: Are You Taking This Dangerous Drug?, HuffPost, March 14, 2011

Related Web Resources:
Topamax

FDA

Cleft Palate Foundation

Full post as published by North Carolina Injury Lawyer Blog on March 26, 2011 (boomark / email).