Topamax Lawyer Reports FDA Asks Healthcare Professionals to Weigh the Benefits and Risks of Topamax

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Topamax can cause birth defects, including cleft palate, cleft lip, and genital and skeletal deformities. Please contact us immediately for a free consultation on a Topamax birth defect. We are standing by now to explain to you questions about Topamax lawsuits, Topamax class action lawsuits, Topamax injuries and Topamax side effects.

The FDA recently released a safety announcement urging healthcare professionals to consider all benefits and risks involved in Topamax treatment before prescribing the antiepileptic drug to women of childbearing age. According to the FDA, Topamax use during pregnancy may be linked to an increased risk of birth defects among exposed infants, particularly cleft lip and cleft palate.

In light of new data concerning the potential link between Topamax use in pregnancy and the development of major birth defects, the FDA has elevated the pregnancy category of the antiepileptic drug from C to D, meaning there is positive human evidence of the drug’s potential to cause fetal malformations. This FDA action was largely influenced by new information collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which identified fetal exposure to topiramate (Topamax) as a risk factor for the development of oral cleft birth defects like cleft lip and cleft palate (Comparative Safety of Topiramate During Pregnancy, NAAED Pregnancy Registry). Upon review of this new Topamax birth defect information, the FDA has asked healthcare professional to carefully weigh the benefits and risks associated with Topamax before prescribing the drug to women of childbearing age, especially for conditions not typically associated with permanent injury or death.

On Friday, March 4, 2011, the Food and Drug Administration (FDA) announced that it is reclassifying Topamax from a Pregnancy Category C to a more serious Category D following receipt of new data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicating an increased risk of birth defects such as cleft lips and cleft palates among babies born to women who took the drug during early pregnancy.

As Topamax lawyers we are reviewing cases involving women who took the drug Topamax® during their first trimester of pregnancy and had a baby born with an oral cleft deformity (oral cleft lip and/or palate) or serious fetal or skeletal deformities. Topamax and its generic versions under the name topiramate are approved for use in the United States to treat both epilepsy and severe migraine headaches.

Ed Wallis is an attorney currently representing and seeking clients who have taken several prescription drugs and claim injuries associated with those drugs, including Wellbutrin, Paxil, Topamax, Avandia, Accutane and Reglan. He also represents clients across the globe pertaining to medical device failures, including the Advanced Bionics HiRes90k cochlear implant, the Gynecare Prolift transvaginal mesh – sling and the DePuy hip implant. In fact, Mr. Wallis and others in the firm in which he practices serve as counsel to persons around the world for defective medical devices and drugs.

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