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FDA Issues Warning For Topamax Birth Defects

Topamax is a prescription drug used to treat epilepsy and migraines.  The Food and Drug Administration (FDA) has increased the Topamax warnings on the packaging of Topamax.  New information demonstrates that there is an increased risk of birth defects when taken when you are pregnant.  To prevent Topamax Birth Defects you will need to use other therapies.

Topamax (topiramate) is manufactured by Johnson and Johnson (JNJ) but bear in mind that there are generic forms of this drug that also increase the risk of birth defects.  The FDA did a thorough review of pregnancy databases and found that there was an increased risk for cleft lip and cleft palate.  A cleft lip/cleft palate occurs when the lip or palate don't completely come together during the first trimester.  More often than not, women don't know they're pregnant at that time.  The FDA has informed healthcare providers that they should warn their patients about this potential birth defects if they are of childbearing age.  If you are pregnant or will become pregnant, you will need to consider taking alternative therapies to prevent Topamax Birth Defects.

Topiramate is also found in the weight-loss drug Qnexa that is manufactured by Vivus Incorporated.  This drug has been rejected by the FDA last year because of the potential for birth defects as well as other reasons.  The FDA is requiring further studies on birth defects  from Vivus before this drug will be marketable. 

According to the North American Antiepileptic Drug Pregnancy Registry,  Birth defects,  such as,  cleft palate/cleft lip occurred in 1.4% of newborns that had been exposed to Topamax.  The drug  was compared to other antiepileptic drugs as well.  The data indicate that other antiepileptic drugs had a  birth defect rate somewhere between 0.38% and 0.55% indicating that Topamax had a much higher birth defect rate.   Newborns of mothers who didn't exhibit epilepsy or take antiepilepsy drugs demonstrate a rate of 0.07%.  This data indicates that infants  whose mothers took Topamax are 21 times more likely  to have Topamax birth defects , then normal.

Topamax Birth Defects may include:

- cleft palate
- cleft lip
- heart defects
- lung defects
- brain  defects
- Arm and  limb defects

The FDA changed the pregnancy category from C to D indicating a Topamax  birth defect complication.  However, there may be situations where the drug's benefit will outweigh its potential risk.  The new label states “there may be an association between the use of Topamax during pregnancy and congenital malformations.”  but prior to this month there was no warning of the Topamax  birth defects.

Topamax Lawsuits being filed nationwide.

Lawsuits for Topamax manufacted by Johnson and Johnson are being filed around the country.  If you have taken Topamax and your child has  experienced birth defects you should contact a Topamax attorney to see if you qualify for a Topamax Lawsuit.  It already has been shown that  Johnson and Johnson actually marketed Topamax for unapproved uses and finally had to go to court and face charges.  JNJ pleaded guilty to the charges and ended up paying a 81.5 million dollar fine for unapproved uses of Topamax. But this new information that Topamax causes birth defects is opens up even more lawsuits against the firm. 

Your Child May be Entitled to Compensation, so act now.

If your child  was born with birth defects and you were taking  Topamax during pregnancy , contact us now to speak with our qualified Topamax Lawyer  about possible compensation. Please use the form below and a Topamax expert will be in touch with you within 24 hours.

Lawsuit Evaluation Form

Please provide us as much information as possible concerning the problems you are experiencing.

Evaluation Information

Please indicate the name of the drug or device. The more details the better.

What were the side effects?

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