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Topamax label updated


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The U.S. Food and Drug Administration announced in January 2014 that there was something amiss about topiramate, which has been marketed as the antiepileptic Topamax.

The FDA reported that the following information would be added to the drug’s warnings and precautions: “Visual field defects have been reported in patients receiving topiramate independent of elevated intraocular pressure. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug.”

As ominous as that reads, it is not all there is to know about Topamax.

Although the FDA approved Topamax in 1996, it was not until 2011 that North American and U.K. epileptic pregnancy registries inspired the FDA to inform “the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy.”

Topamax’s prescribing information reads, “If you take Topamax during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.”

Women who used Topamax during pregnancy and whose children were born with cleft lip and cleft palate could have averted the risk if they had known about it. The manufacturer of the drug, Janssen Pharmaceuticals, was responsible for knowing about the increased risks and for ensuring that patients and their health care professionals knew about them, plaintiffs may assert in a Topamax lawsuit.

Topamax victims deserve compensation for the treatment that they did not deserve. They also deserve the peace of mind that accompanies seeing justice served.

Offering a free consultation to one who requests one either through the website or toll-free, the experienced attorneys at Reich & Binstock proudly fight hard for victims such as these. Reich & Binstock’s attorneys have 30 years of experience and a proven track record at trying pharmaceutical injury cases.

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