Topamax birth defects (part 1)

April 25, 2011 @ 04:56 PM -- by

As a Texas Topamax birth defects lawyer, I am following the drug and its various problems closely. Topamax, which is made by Ortho-McNeil Janseen Pharmacueticals Inc., has been used to treat many issues. Topamax (which is generically called "topiramate") treats epilepsy in both children and adults. The drug was originally marketed as an anticonvulsant. Topamax is also used to treat children with Lennox-Gastaut syndrome, which is a disorder that causes seizures and developmental delay. Topamax has been approved by the United States Food and Drug Administration (FDA) for the prevention of migraines. Psychiatrists have used Topamax and its generic to treat bipolar disorder, as well as to augment psychotrophics. However, one review in 2006 found insufficient evidence for the drug’s use with bipolar illness. Topamax has also been investigated for use in treating obesity and alcoholism and obesity. The drug has also been used in clinical trials to treat posttraumatic stress disorder, which seems to be on the rise.

However, on March 4, 2011, the U.S. FDA placed a safety warning after a study showed that Topamax greatly increases the risk of birth defect to newborns. In this study, it was shown that the incidence of newborn children with oral clefts more than doubled in mothers who were simply exposed to the drug while they were pregnant. Moreover, a baby born to a mother who took Topamax while pregnant is an amazing eleven times more likely to be born with cleft lip and/or cleft palate. A baby born to a mother who took Topamax while pregnant is also sixteen times more likely to be born with hypospadias, which is a male genitalia malformation. This birth defect, which mainly affects males, causes the opening of the urethra to be on the underside, rather than at the end, of the penis.

Interestingly, the U.S. FDA knew about the birth defect risk three years earlier. Topamax birth defects lawyers are aware that, in the July 2008 issue of Neurology, researchers reported that "(e)xposure to the antiepileptic medicine Topamax in the first trimester of pregnancy carried a higher-than-usual rate of congenital malformations."

In the study titled, "Topiramate in pregnancy — Preliminary experience from the UK Epilepsy and Pregnancy Register", researchers found that 13 out of 178 patients (17.4%) taking Topamax gave birth to children with some type of malformation. Also 16 of the 178 births resulted in oral clefts, hypospadias or some other problematic malformations.

There was also a Topamax study in 2006 in the medical journal Epilepsia. This study, titled "Pregnancy Outcomes in Topiramate-treated women" indicated that 9 of the 78 pregnant women which were studied had babies with oral clefts or some other kind of birth defect.

These studies helped the FDA to determine that the warning on the drug was inadequate. Because the warnings were so weak, many mothers did not know that they could have been exposing their child to the risk of Topamax birth defects. This March 4, 2011 FDA requirement made the manufacturers of the generic topiramate (Topamax) to greatly strengthen warnings for the medication because of the data which linked Topamax to the aforementioned birth defects (cleft lip, cleft palate, and Hypospadias).

Call Texas Topamax birth defects attorney Scott Nelson if you need help with a Topamax birth defects case.