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Topamax-birth defects link got patients’ attention

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U.K.-based The Telegraph published March 25 a feature about Elisabeth Crank, an epileptic who, after suffering a miscarriage, decided before she would get pregnant a second time to forego taking her prescribed medication. Crank has a healthy 2-year-old daughter, but she took health risks and endured multiple weekly seizures contrary to conventional medical advice.

Crank takes topiramate now but would consider abandoning it before getting pregnant again, according to the article.

This piece is not about Crank’s self-therapeutic decision. Doing the unimaginable in order to avoid the unthinkable is a medical ethical matter in another orbit. Don’t even go there. Forget about it.

Instead, this piece is about the increased risk of birth defects that the averted drugs pose, and it is about the rights of the victims to recoverable damages.

Millions of women took an antiepileptic unaware of the risk of birth defects because the manufacturer failed to warn them, and the results were catastrophic.

Plaintiffs in Topamax lawsuits have sought compensation for medical costs and other losses associated with what should have been advisedly avoidable exposure to an arguably unreasonable increased risk.

The U.S. Food and Drug Administration approved Topamax, the generic of which is topiramate, in 1996. It was not until March 2011 that the FDA announced, “New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy.”

The FDA further explained in the announcement that Topamax was “approved to treat certain types of seizures in people who have epilepsy” and “to prevent migraine headaches, but not to relieve the pain of migraines.”

An FDA-approved September 2012 Topamax medication guide reflected the increased risk of birth defects, including this statement: “These defects can begin early in pregnancy, even before you know you are pregnant.”

That crucial information slipped through the pre-market checks. Medical scientists are still not universally convinced that they know everything that they need to know about the link between birth defects and taking Topamax. For instance, researchers at the Department of Medicine and Neurosciences at the Royal Melbourne Hospital and the University of Melbourne examined the associations between certain fetal malformations and in-utero antiepileptic drug exposure. More than 1,700 fetuses were involved in the study. The broader use of Topamax was a concern.

Writing for a piece accepted in March for the journal Acta Neurologica Scandinavica, the authors found, “More extensive data are desirable, particularly in relation to topiramate, which is being used increasingly as a migraine prophylactic in women of childbearing potential.”

As this space reported April 1, researchers concluded from their study that there were “statistically significant associations” between “topiramate exposure” and birth defects affecting the brain and urethra. Women unwittingly took the increased risks of giving birth to a child with such congenital defects.

A law firm with a proven track record in trying pharmaceutical injury cases is an asset to those congenital victims of Topamax who are entitled to compensation. The Topamax attorneys at Reich & Binstock want to help. For a free consultation, one may call the law firm toll-free at 1-866-LAW-2400 or request free up-front legal advice online through the firm’s website, www.reichandbinstock.com.