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Debate Over Topamax Oral Cleft Birth Defects Continues

September 14, 2012 – Researchers and doctors have yet to reach a consensus regarding the risk women face of giving birth to children with a cleft lip or cleft palate when Topamax (generic: topiramate) is used during the first trimester of pregnancy. A roundtable discussion was published this week by the American Journal of Obstetrics and Gynecology (AJOG), which reviewed the findings of a July study that identified a fivefold increase in the risk of oral cleft birth defects when Topamax is used in the first trimester of pregnancy (a time when many women may still be unaware they are pregnant). First approved by the U.S. Food & Drug Administration (FDA) in 2004, Topamax is a best-selling prescription drug designed to be used alone or with other medications to treat certain types of seizures in patients who have epilepsy.

Free Topamax Lawsuit Evaluation: If you or a loved one has a child who was born with a cleft lip or cleft palate after the mother took Topamax during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Topamax and we can help.

What’s the problem?

The roundtable discussed the results of the new research, and ultimately determined that there is a definitive link between Topamax and cleft lip and cleft palate, but that additional studies need to be conducted in the future. One of the panel’s participants proposed a dose-response study to determine whether higher doses of the drug lead to an increased risk of oral cleft birth defects in infants. Another said that while the findings of the research were not compelling enough to be fully conclusive, expecting mothers should be aware of the risks associated with continuing to take Topamax during pregnancy.

“Personally, if I see someone exposed to [Topamax], I am going to have the lips and palate well-visualized on ultrasound,” said Dr. Alison Cahill, an assistant professor of Obstetrics and Gynecology at Washington University in St. Louis. “But I’m not at the point where I would tell a patient who is on [Topamax] to stop the medication before conception.”

In March 2011, the FDA required drugmaker Ortho-McNeil Neurologics (a subsidiary of Johnson & Johnson) to add new warnings about the risk of birth defects associated with Topamax and generic topiramate when taken during the first trimester of pregnancy. At the time, the administration advised prescribing doctors to avoid giving Topamax to expecting mothers and women who may become pregnant, in large part due to the fact that there are a wide variety of epilepsy and migraine headache medications available that do not carry the same risk of serious side effects.

McNeil currently faces a growing number of lawsuits filed in courthouses around the country on behalf of babies allegedly born with oral cleft birth defects after their mothers took Topamax during pregnancy. The suits claim that the company knew – or should have known – about the risks associated with taking Topamax during pregnancy, but that it failed to warn the public and medical communities about these risks.

Do I Have a Topamax 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 and cleft palate cases in all 50 states.

Free Topamax Lawsuit Evaluation: If your child or other loved one was born with a cleft lip / palate after being exposed to Topamax in the womb, you should contact our law firm immediately. You may be entitled to compensation by filing a Topamax birth defects suit and we can help.

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