Topamax Warning: The Risk of Birth Defects
Having medicated with epilepsy drug topiramate, known by the brand Topamax, while pregnant poses the dangers of oral cleft birth defects, namely cleft lip and cleft palate. This is according to a new warning the FDA has issued.
Appearing in a new drug registry data, the risk of oral birth defects is up to sixteen times higher in women under topiramate medication, or its generic equivalents while being pregnant.
Topiramate is a drug approved by the FDA as treatment for seizures following epilepsy and is also used to prevent migraines. In other cases, it is used on an off-label basis as treatment for obesity, bipolar disorder, and alcoholism.
According to Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, “Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age.” He also stated “Alternative medications that have a lower risk of birth defects should be considered.”
It can be cited from the North American Antiepileptic Drug (AED) Pregnancy Registry that the FDA found 1.4% of infants exposed to topiramate during pregnancy has developed cleft lip or cleft palate. The data is compared with 0.38-0.55% of infants exposed to epilepsy drugs other than topiramate. The risk is even much lower in infants of mothers who did not take epilepsy drugs during pregnancy, registered at 0.07%.
The European drug registries reported the same results.
Following this new information, the FDA requires a stronger warning on topiramate label. In fact, the warning for pregnancy category has been updated from category C to a category D risk. It indicates that there is positive evidence of fetal risk based on human data.
Cleft lip and cleft palate are birth defects that develop as parts of the lip or palate fail to fuse together within the first trimester of conception. The severity of the defects ranges from a small notch at the lip to a groove that runs towards the roof of the mouth and nose. The condition leads to problems with eating, talking, and ear infections.
Researchers state that corrective surgery for most children with cleft lip or cleft palate can be an effective remedy.
Still, the FDA cautions pregnant women and women of childbearing age to discuss other treatment options with their doctor before taking topiramate, declaring their pregnancy or intention to get pregnant. However, individuals under topiramate medication should not cease medicating with it unless they are advised by their doctor.
Be well-informed and get the latest facts on Topamax birth defect lawsuit and know your legal rights if you suffer alarming side effects.
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