Topiramate medications have been associated with major health complications for several years, among them is Topamax, which can cause birth defects. In March of 2011, the FDA moved the drug from pregnancy category C to pregnancy category D, citing studies which show positive evidence of cleft lip and cleft palate abnormalities. Medications in pregnancy category D have displayed a causal link to fetal malformation and are only prescribed to pregnant women in rare situations.

Topiramate is prescribed for many different conditions. These include epilepsy, migraines, Lennox-Gastaut Syndrome and bipolar disorder. It is often used off-label to produce weight loss and curtail binge eating. Medical studies are reviewing its efficacy in treating post traumatic stress disorder and infantile spasms. Doctors aren’t sure exactly how the substance helps migraines or produces anti-epileptic effects. Researchers have found that topiramate is effective at blocking certain sodium channels, functioning as an antagonist for some glutamate receptors and inhibiting the carbonic anhydrase enzyme. While these can help explain the drug’s efficacy, they do not provide a formal link.

Previous investigations have also reviewed its use for treating alcoholism and methamphetamine addiction. There are many other off-label uses for the drug, most of them for helping to manage psychiatric disorders. However, topiramate is not officially approved for use in this way. In May 2010, the drug’s manufacturer, Ortho-McNeil, was fined by the FDA after it promoted topiramate for use in people with mental problems. Many Topamax associated birth defects have been linked to off-label usage of the medication.

The FDA has tracked the usage of Topamax and the birth defects the drug can cause. It was first approved in 1996, though animal studies had shown some fetal abnormalities in the presence of topiramate. In 2008, a study by several United Kingdom neurologists was published in Neurology, a peer-reviewed neurology journal. After reviewing the UK epilepsy and pregnancy register, the researchers found an increased risk of cleft lip and cleft palate in women who had taken topiramate during the first trimester of pregnancy. Of the 178 live births that were reviewed, 16 children were born with major congenital malformation. The most common deformity was cleft lip or palate, which was 11 times more likely to occur in children whose mothers had taken the medication. Among other Topamax related birth defects was hypospadias, which occurred in four births. This abnormality concerns improper formation of the urethra in male children. The urethra in these children terminates on the underside of the penis instead of the front, causing major cosmetic and functional problems.

Most children who are born with cleft lip or palate will require major cosmetic surgery to restore proper function to the mouth. Without it, a child will have trouble eating and talking, and will be more likely to suffer from ear infections. The FDA believes around 32 million topiramate prescriptions were filled between January 2007 and December 2010. The substance was approved in 2012 for weight loss, so it is still possible to receive the drug. However, any woman who has had a child with Topamax associated birth defects should consider speaking to a drug injury lawyer. Many women have already received restitution for their child’s suffering, and these experts can help a victim work through the legal process.