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New Study Links Topamax to Cleft Lip

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. Oral defects such as cleft lip and cleft palate occur when parts of the lip or palate fail to fuse together completely in the womb, resulting in the child being born with defects as small as a notched lip to as large as an open groove from the mouth to the nose.

Free Topamax Cleft Lip Lawsuit Evaluation: If you or a loved one gave birth to a child with cleft lip or cleft 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 suit against the manufacturer of Topamax and we can help.

What’s the problem?

July 19, 2012 – The new research, which was published this week in the American Journal of Obstetrics & Gynecology, involved data from the Sione Epidemiology Center Birth Defects Prevention Study, as well as the National Birth Defects Prevention Study. Cumulatively, these independently-conducted studies looked at more than 18,000 female test subjects and found that expecting mothers who used Topamax during their first trimester of pregnancy were more likely to have cleft lip or cleft palate by a factor of five or more.

The study was published just one day before the U.S. Food & Drug Administration (FDA) decided to approve a new weight loss drug named Qsymia (formerly known as Qnexa), which contains both phentermine and topiramate, the active ingredient in Topamax. Due to the risk of birth defects associated with topiramate, Qsymia is not recommended for use by pregnant women. The FDA initially rejected Qsymia in October 2010 due to topiramate’s potential to cause cleft lip and cleft palate.

First approved by the FDA in 2004, Topamax is generally prescribed to treat epilepsy and migraine headaches. It became available as a generic in 2006. In March 2011, the administration issued a press release stating that it was requiring Topamax warning labels to be updated to include verbiage about the risk of birth defects when the drug is used by expecting mothers during the first trimester of pregnancy. In the press release, the FDA advised doctors to avoid prescribing Topamax to women who are pregnant or who may become pregnant, as there were a number of other effective medications on the market that did not carry the same risks.

Since last year’s warning, a large number of Topamax lawsuits have been filed against Ortho-McNeil in courthouses around the country. These claims allege that oral cleft birth defects could have been avoided if consumers and the medical community had been properly warned about the risk of becoming pregnant while using Topamax.

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 and cleft palate cases in all 50 states.

Free Topamax Cleft Lip Lawsuit Evaluation: If you or a loved one gave birth to a baby with cleft lip or cleft 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 cleft lip suit and we can help.

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