Women taking Topamax during pregnancy are over 20 times more likely to give birth to babies with birth defects
Recently, the U.S. Food and Drug Administration (FDA) issued a warning concerning the anti-epileptic and migraine drug, Topamax. The FDA stated that Topamax side effects include birth defects in infants born to mothers taking the drug during their first three months of pregnancy. Incidences of the development of cleft lips and palates occurred at a much higher rate with women taking the anti-convulsant than those taking either another anti-convulsant drug, or no drug at all.
The Topamax birth defect warning came after the latest data showed that pregnant women taking Topamax were over 20 times more likely to have babies with oral cleft deformities, either a cleft palate or cleft lip.
During the first trimester of pregnancy, many women do not realize that they are pregnant, and therefore, continue to take Topamax as prescribed by their doctor. Unfortunately, it is during this first trimester of pregnancy that the oral cleft develops. Topamax birth defects are not limited to just oral cleft deformities, but also other defects such as spina bifida, limb malformations, genital birth defects, and craniofacial defects, among others.
FDA ELEVATED ELEVATED FROM “PREGNANCY CATEGORY C” TO
A MORE DANGEROUS “PREGNANCY CATEGORY D”
Besides the warning about Topamax birth defects, the FDA also moved the drug to its Pregnancy Category D. This means the drug has shown proven risk of causing birth defects, based on human studies.
The FDA urged all women of childbearing age to consider other medication options if they must be treated for epilepsy. The doctor must decide if the risks involved with treating a pregnant woman with Topamax outweigh the risks of a mother inclined to epileptic seizures that have been unmanageable with other drugs. If a woman becomes pregnant and is taking Topamax, she should inform her doctor immediately.
It is important to note, as well, that two subsidiaries of Johnson & Johnson had to pay $81.5 million in criminal fines for illegally promoting Topamax for uses for which it did not have federal approval. In spite of the FDA’s warnings, the companies have not announced any Topamax recall programs.
Any mother who took Topamax during pregnancy and had a baby with birth defects should contact an attorney immediately to see if she may be entitled to compensation of any sort. The attorneys at Kogan & Associates have successfully pursued similar cases and have the experience to help you navigate through the legal system. Give us a call or fill out our contact form and let us hear about your situation.
If you took Topamax during your pregnancy, contact us immediately to discuss your possibilities.
If you have taken Topamax during pregnancy and your baby was born with birth defects, there is a strong possibility that this was caused by Topamax. Contact Kogan & Associates today to find out if you may be entitled to significant financial compensation.