Women taking Topamax, a popular drug used to treat headaches and epilepsy, are more than three times more likely to give birth to a child with birth defects related to a child’s mouth such as: cleft lip or cleft palate compared with women taking other brands of epilepsy drugs. Researchers estimate that infants born to women taking Topamax have a 1.4% chance of a having a birth defect relating to their mouth.
As a result of these safety concerns, the FDA is requiring Johnson & Johnson, the manufacturer of Topomax and to incorporate stronger warnings about use and pregnancy.
In particular, Topamax has been associated with birth defects such as:
- Cleft lip
- Cleft palate
- Heart defects
- Facial deformities
- Deformed limbs
While some of these Topamax birth defects, were known by the medical community for years, the product’s written warnings were inadequate for expectant mother’s to make informed medical decisions. Moreover, there was no warning about Topamax’s reduction in effectiveness in the oral contraceptives taken by women.
A study published in 1996, the same year the FDA approved Topamax for treatment for partial onset seizures, indicates that seizure medications– such as Topamax may substantially increase the likelihood of a woman becoming pregnant while she is on birth control.
The net result of the inadequate Topamax warnings that many women were likely taking Topamax before they knew they were pregnant in the first place. Given the nature of fetal development, it is likely that many of the facial malformations and cleft palates are due to the mother taking Topamax during the vital first trimester when many of these features form.
Rosenfeld Injury Lawyers is examining all aspects of Topamax claims including birth defects. As long-time advocates for injured children, we are prepared to evaluate cases both in terms of the immediate impact to child and family as well as the long-term needs of the children as they endure disabilities for the remainder of their lives.
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