Federal drug regulators have issued a disturbing new warning for women who are pregnant or plan to become pregnant. Research shows that the popular migraine medication Topamax seriously raises the risk of birth defects such as a cleft lip or cleft palate, especially when taken during the first trimester of pregnancy.
New drug registry data shows that the risk of oral birth defects is up to 16 times higher among women who take Topamax or its generic equivalent during pregnancy. Other genital deformities and fetal or skeletal malformations are also more likely to occur.
Topamax is used to prevent severe migraine headaches and treat seizures associated with epilepsy. It is also used on an off-label basis to treat other conditions such as obesity, bi-polar disorder, and alcoholism.
In response to the dramatically increased risk of Topamax-associated birth defects among moms-to-be, federal drug regulators announced that the drug will carry a stronger warning label. They also recommend that health care professionals prescribe alternative medications that have a lower risk of birth defects.
Cleft lip and cleft palate typically occur during the first trimester of pregnancy, when the lip or palate does not fuse correctly. For women who already used Topamax during pregnancy, the new warning may be too late. Additionally, because many women are unaware that they are pregnant for at least a portion of their first trimester, pregnant mothers may still be unknowingly exposed to the risk. Our Chicago medical malpractice lawyers at Pintas & Mullins Law Firm are investigating the unusually high rate of birth defects associated with Topamax and urge women who were harmed by this dangerous medication to step forward.
If you believe you may have a case, please call our firm at (800) 774-7120. Your initial consultation is free.