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Topamax Warnings

The Food and Drug Administration issued a Topamax birth defects warning in March 2011 after researchers found that the drug could increase the risk of side effects such as cleft lips and cleft palates when taken during pregnancy. According to the FDA’s warning about Topamax, women who used the drug during the first trimester of pregnancy were 21 times more likely to give birth to a child with these conditions—known collectively as oral cleft defects.

As a result of these findings, the FDA strengthened the warning label that accompanied Topamax. The agency upgraded the drug to its Pregnancy Category D, meaning that there was strong evidence that using Topamax during pregnancy could cause birth defects.

Topamax may also increase the risk of other congenital birth defects, including spina bifida, heart and lung defects such as persistent pulmonary hypertension of the newborn (PPHN), craniofacial defects, neural tube defects, limb malformations or genital malformations such as hypospadias.

If further evidence emerges about the link between Topamax and birth defects, the FDA could decide to further strengthen the drug’s warning label. The FDA’s next and strongest category—Pregnancy Category X—means that the drug should never be taken by pregnant women due to the risk of side effects. The FDA could also decide to issue a Topamax recall, although no plans for either measure have been announced so far.

If you or a loved one took Topamax while pregnant and gave birth to a child with a cleft lip, cleft palate or other congenital birth defects, you may qualify to file a lawsuit. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling 1-866-275-4454, or by filling out the free case evaluation form located on this page.

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