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Topamax and Cleft Palate

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FDA Warning- Topamax Cleft Palate

 New warnings by the Food and Drug Administration (FDA) have come out for the epilepsy drug Topamax (topiramate) and its association with Topamax Birth Defects.  These Topamax birth defects include Topamax cleft palate and cleft lip as well as other facial deformities. As part of this FDA Topamax Warning,  Doctors should use alternative therapies for women of childbearing age to prevent these birth defects.  Make sure to tell your healthcare provider if you are  pregnant, will become pregnant or are breastfeeding.  It is known that Topamax passes into breastmilk.  Topamax is also used to prevent migraines and has a number of other off-label uses.  Topamax is produced by Ortho-McNeil pharmaceuticals which is a subsidiary of Johnson and Johnson (JNJ).

Topamax Cause Birth Defects

A Topamax cleft palate or Topamax cleft lip happens when the lip or palate do not completely come together during development in the first trimester.  If this happens, surgery is generally performed to close the area and children generally do well after this treatment according to the FDA.  If you took Topamax when you were pregnant and gave birth to a cleft palate/lip baby you should contact a Topamax attorney to see if you qualify for a Topamax Lawsuit

New data from the Drug Registery has caused the FDA to require a stronger warning label on packaging of Topamax as well as the patient medication guide.

Topamax precautions and warnings include the potential for dangerous interations with other drugs.  If you have kydney dysfunction in general, liver dysfunction, glaucoma, psychiatric problems, kidney stones, allergies and/or paresthesia, you need to be monitored closely by your physician for adverse side effects.  Paresthesia is an abnormal sensation of the skin.  Abnormal sensations include numbness, tingling, pricking, burning or creeping. 

The FDA has reclassified Topamax from a pregnancy Category C drug to a Category D which means there is clinical proof that this drug generates Topamax Birth Defects.

If you have taken Topamax while pregnant and gave birth to and your child suffers from a Topamax birth defect such as Topamax cleft palate or Topamax  cleft lip or any other facial or limb malformation, you may qualify for a Topamax Lawsuit.

You May be Entitled to Compensation, so act now.

If you or a loved one has been injured as a result of taking Topamax therapy, contact us now to speak with our qualified professionals about possible compensation.  Please use the form below and a Topamax Expert with contact you wihtin 24 hours.


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