Topamax: Now a Pregnancy Class D Drug
The FDA reclassified Topamax as a Pregnancy Class D drug because of the risk of cleft lips and cleft palates in children born to women using
Topamax. Before March 4, 2011,
Topamax was classified only as a Pregnancy Category C drug.
The FDA Classifies Drugs Based on Their Risk of Causing Birth Defects
To identify which drugs may pose risks for babies born to pregnant women, the FDA assigns all approved drugs to Pregnancy Categories based on data obtained from animal studies, clinical studies, or experience. There are five Pregnancy Categories for drugs: Category A, B, C, D, and X, with A being the least harmful and X being the worst:
- Category A: Adequate and well-controlled (AWC) studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters).
- Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no AWC studies in humans, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. OR animal studies have not been conducted and there are no AWC studies in humans.
- Category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no AWC studies in humans, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. OR animal studies have not been conducted and there are no AWC in humans.
- Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, BUT the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective).
- Category X: Studies in animals or humans have demonstrated fetal abnormalities OR there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, AND the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).
As these definitions demonstrate, changing
Topamax from a Category C to a Category D pregnancy drug was significant: it basically means that the risk of birth defects is only outweighed if
Topamax is needed to keep the patient from dying. That might be true for extreme forms of epilepsy. However, that would NEVER be a justification for using
Topamax as a treatment for migraine headaches, one of the FDA-approved uses of
Topamax, since there are numerous other drugs for migraines that do not come with the
Topamax risk of cleft lips and cleft palates.
You May Learn More About Topamax and its Side Effects HERE.
Topamax Birth Defect Lawsuits
If your child was born with a birth defect such as a cleft lip, cleft palate, or spinal bifida after the mother used Topamax shortly before or during her pregnancy, the child and parents may have a legal claim against the manufacturer of Topamax. Consider contacting the Topamax attorneys at DeCarli Law for a free, no-obligation telephone consultation.