
Topamax Birth Defects Lawsuit
What Is The Topamax?
Topamax (generic topiramate) was first introduced as a medication to treat epilepsy, which is a neurological disorder characterized by recurrent, uncontrolled seizures. In 2004, the FDA approved Topamax for an additional use of treating migraines, and it has since become one of the most widely prescribed migraine medications in the United States. The drug is also often prescribed off-label to treat bipolar disorder.
Topamax Birth Defects
In the July 22, 2008 issue of the medical journal Neurology, a small study was published which linked the use of Topamax during pregnancy to an increased risk of serious birth defects. The increased risk was seen among women taking the drug to treat epilepsy, either alone or in combination with other epilepsy drugs.
Researchers followed 203 women who used Topamax during pregnancy. Of the 178 babies born to these women, 16 were found to have major birth defects. Four of the babies were born with a cleft lip or palate, which is a rate 11 times higher than would be expected in the general population. Another four babies were found to have genital defects, which is a rate 14 times higher than would be expected in the general population.
Although the study only followed women who used Topamax to treat epilepsy, it raises substantial concerns about the use of the drug among women of childbearing age to treat migraines. Women are three times more likely to suffer from migraines than men, and the condition frequently occurs in women of childbearing age.
Topamax Warning
The U.S. Food & Drug Adminstration (FDA) recently linked Topamax (generic: topiramate) to an increased risk of birth defects in children born to mothers that took the drug during pregnancy. More specifically, Topamax, the popular Epilepsy drug, which was also promoted “off-label” for psychiatric health has been linked to Cleft Lip, Cleft Palate and genital malformations including Hypospadias.
On March 4, 2011 the FDA required the manufacturers of topiramate (Topamax) to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects, including cleft lip, cleft palate, and genital malformations including Hypospadias.
However, the FDA had known of the birth defect risk three years prior. In the July 2008 issue of Neurology, researchers reported that “Exposure to the antiepileptic medicine Topamax in the first trimester of pregnancy carried a higher-than-usual rate of congenital malformations.”
Read FDA Topamax Safety Communication
In the study titled, “Topiramate in pregnancy — Preliminary experience from the UK Epilepsy and Pregnancy Register”, researchers found that 13 out of 178 patients taking Topamax gave birth to children with birth defects.
Topamax Attorney
If you have experienced Topamax side effects or have had a child born with birth defects call our Topamax birth defects lawyer today to find out about an Topamax lawsuit. With offices in Washington D.C. and throughout Florida we are ready to help Topamax side effects victims nationwide. Let our Topamax birth defects Attorneys evaluate your case for free today. Fill out our online case evaluation form on this page or call us toll free at: 1.800.856.6405 for your free, confidential case evaluation.
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