This latest announcement by the FDA (see below) is particularly worrisome, as it demonstrates the teratogenic side effects of Topamax and the generic versions of this commonly utilized drug.
The U.S. Food and Drug Administration (FDA) issued a warning about Topamax (topiramate), an anticonvulsant medication which is used in the prevention of migraine headaches and epileptic seizures. New medical study shows that Topamax and its generic versions increases the rate of cleft lip and cleft palate deformities if taken by women who are pregnant.
Cleft lip and cleft palate deformities are holes in the roof of the mouth that result from improper fusing of the lip and the palate during fetal development during pregnancy. The mouth birth defects can cause problems with eating and talking if not treated with surgery.
Product labeling for Topamax cautions about the risk of birth defects associated with the medication, but the warning label will now be revised to include stronger language that there is "positive evidence of human fetal risk based on human data."
Cleft lip and palate is very treatable; however, the kind of treatment depends on the type and severity of the cleft.
Most children with a form of clefting are monitored by a cleft palate team or craniofacial team through young adulthood. Treatment procedures can vary between craniofacial teams. For example, some teams wait on jaw correction until the child is aged 10 to 12 (argument: growth is less influential as deciduous teeth are replaced by permanent teeth, thus saving the child from repeated corrective surgeries), while other teams correct the jaw earlier (argument: less speech therapy is needed than at a later age when speech therapy becomes harder).
Still prevention is better than the cure, so best avoid the use of Topamax during pregnancy or if cannot, then use contraceptive devices.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.