A study published in early March by a team of Australian researchers establishes a strong link between Topamax and congenital birth defects. The study was conducted by the Department of Medicine and Neurosciences at the Royal Melbourne Hospital and by the University of Melbourne.
In their study, the Australian research team discovered a link between exposure to Topamax in the womb and the development of hypospadias and problems with proper brain development. Topamax has been firmly connected to the birth defects known as oral clefts, such as cleft lips and cleft palates. The Australian study makes mention of neither Topamax cleft lip nor Topamax cleft palate.
Still, this research illustrates that there appears to be more birth defects caused by Topamax, which is even more reason to be cautious when prescribing or taking the anti-epileptic drug during pregnancy.
The Australian researchers concluded that further research is necessary into the organ specific birth defects caused by Topamax exposure.
Topamax was approved by the U.S. Food and Drug Administration (FDA) in 1996. It was not until 2011 that the FDA released a safety announcement about Topamax. The release stated that new information indicated a firm connection between Topamax and congenital birth defects, especially oral clefts.
Furthermore, the FDA mentioned data collected in a study conducted by the North American Anti-epileptic Drug (AED) Pregnancy Registry that establishes a strong link between the development of oral clefts and exposure to Topamax in the womb during the first trimester of pregnancy. The likelihood of children developing oral clefts if exposed to Topamax in the womb was found to be 1.4 percent, whereas children who were not exposed to Topamax were only .07 percent likely to develop an oral cleft, according to data collected by the North American AED Pregnancy Registry study.
Following information released from the North American AED Pregnancy Registry study and others, the FDA re-classified Topamax as a Pregnancy Category D drug, signifying that human data exists showing a link between exposure to Topamax and the development of congenital birth defects.
If you or someone you love ingested Topamax while pregnant resulting in a baby born with one or more birth defects, you and your loved one may be eligible to receive compensation for your and your baby’s pain, suffering, and loss.
Contact a Topamax lawyer at Carey Danis & Lowe today for a free consultation about your case, and for assistance in filing a Topamax lawsuit. A Topamax lawyer can be reached by calling 800.721.2519 or by submitting a legal claim form.References: Pharmaceutical litigation, Topamax