FDA, Topamax, Cleft Lip & Birth Defect

FDA, Topamax, Cleft Lip & Birth Defect: Back in March 2011, the FDA review of topamax was a startling revelation to many of its users.  The FDA review of topamax published in 2011 concerning the use of TOPAMAX® during pregnancy stated that if you take Topamax during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate.  TOPAMAX® is a prescription medicine used:

1. to treat certain types of seizures (partial onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older,  with other medicines to treat certain types of seizures (partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older
2. to prevent migraine headaches in adults.

The FDA published its concerns as follows:

• TOPAMAX® can harm your unborn baby.
• If you take TOPAMAX® during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate.
• These defects can begin early in pregnancy, even before you know you are pregnant.
• Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors.
• There may be other medicines to treat your condition that have a lower chance of birth defects.
• All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of TOPAMAX®.

 

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Contact Us

At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases. If you or your child suffered a birth defect – cleft lip or cleft palate – that you believe may be related to using Topamax during pregnancy and would like your case evaluated, please contact our office at 1.844.329.5955.

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WE ARE HERE TO HELP YOU PROTECT YOUR LEGAL RIGHTS

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