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FDA Issues Topamax Warning Concerning Birth Defects

New information is available on Topamax (topiramate) which is a prescription drug used to treat certain types of epileptic seizures and migraines.  It is now known that taking Topamax while pregnant increases your risk of bearing a child with certain birth defects.  These Topamax Birth Defects include  cleft palate, cleft lip and other facial malformations as well as limb deformities.  For these reasons the Food and Drug Administration (FDA) has issued a new Topamax Warning.  The Drug Registry data reports that facial Topamax Birth Defects are 16 times greater with women who took topiramate or its generic forms during pregnancy.  Topamax is manufactured by Ortho-McNeil pharmaceuticals which is a subsidiary of Johnson and Johnson (JNJ).

The FDA approved Topamax for the treatment of epileptic seizures and to prevent migraines.  However, Topamax has been marketed for off-label treatment such as obesity, bipolar disorder and alcohol abuse.  These off-label uses were not approved by the FDA and Ortho-McNeil pharmaceuticals ended up paying over $81 million in fines for improper use of the drug.

In response to this new information on Topamax Birth Defects, the FDA has required Ortho-McNeil to place a stronger Topamax Warning on their packaging.  The warning includes the increased risk of cleft palate and cleft lip and other facial and limb malformations.  The FDA has also reclassified Topamax to a pregnancy Category D indicating the increased risk for birth defects.  Topamax was formerly categorized as a Category C.

If you have already taken Topamax and your child exhibits any of the Topamax birth defects  such as cleft palate, Limb deformaties or Spina Bifida you should contact an Attorney who specializes in the Topamax Lawsuits that are now forming across the Country.

Increase Potenial For Birth Defects

If you are pregnant or thinking about having a child and taking Topamax, you should talk to your health care provider.  Let your doctor know if you have kidney dysfunction, liver dysfunction, glaucoma, respiratory dysfunction, diarrhea and/or allergies.  Make sure to discuss any vitamins and/or natural supplements you might be taking as they might interact with Topamax.  Tell your doctor if you are on a low carbohydrate diet such as Atkins Diet where you are producing ketones in your urine.  And, of course let he/she know if you are pregnant, will become pregnant and/or breastfeeding. 

The FDA also put out a Topamax Warning to physicians to make sure their female patients of childbearing age are aware of the increased potential for Topamax Birth Defects.  Doctors should seek alternative therapies for pregnant women or women who will become pregnant.

 You May be entitled to Compensation, so act now.

If your child  has birth defects as a result of you or a loved one  taking Topamax therapy, contact  a Topamax Attorney who is an expert in the  FDA Topamax Warning and the Topamax Lawsuit  about possible compensation.  Call us now at 877-222-7069 or the form below to contact us. An expert in the Topamax Birth defects will contact you within 24 

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