New research has linked the side effects of Topamax (topiramate) to a heightened risk for an oral congenital defect known as cleft lip. Use of Topamax by pregnant women may cause this and other debilitating malformations. The lawyers at Schmidt & Clark, LLP are reviewing potential claims for children who may be entitled to compensation through a Topamax cleft lip lawsuit.
Topamax Birth Defects Update 7/19/12: A recently-published study, based on more than a decade’s worth of data, has confirmed prior research which identified a strong link between Ortho-McNeil’s controversial anti-convulsant Topamax (generic: topiramate) and oral cleft birth defects. This risk is greatest when expecting mothers take Topamax during their first trimester of pregnancy, a time when many women may still be unaware they are pregnant. Click here to learn more.
Free Topamax Cleft Lip Case Evaluation: If you have given birth to a child with a cleft lip or other congenital malformation after taking Topamax during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
On March 4, 2011, the U.S. Food & Drug Administration (FDA) required drug makers to strengthen warnings for Topamax because of increasing data linking the medication to cleft lip and a number of other extremely serious birth defects. The new warning comes after several years of controversy surrounding the safety and efficacy of the drug as well as marketing practices used by at least one manufacturer.
In its press release, the FDA stated “based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data.”
Signs & Symptoms of Cleft Lip
Signs and symptoms of a cleft lip can range from a small notch in the red part of the upper lip (mild) to complete bilateral cleft lip (severe). The muscle, skin and lining of the lip are missing in the gap of a cleft and in the wrong place on each side. Babies born with a cleft lip may have problems eating, which can be a big problem for a newborn baby.
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Do I have a Topamax Cleft Lip Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Topamax lawsuits. We are handling individual litigation nationwide and currently accepting new cleft lip cases in all 50 states.