What Do The FDA’s Pregnancy Categories Mean for Topamax?

We already told you that the U.S. Food and Drug Administration (FDA) changed Topamax’s pregnancy category from category C to category D. Topamax users may want to know what this means, and more broadly, where these categories fit within the entire system. Fortunately, the University of Washington maintains a list of the categories, which we will provide for you.

• Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
• Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
• Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• 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 potential benefits may warrant use of the drug in pregnant women despite potential risks.
• Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

So, as a category D drug, Topamax is now low on the list, and the only thing keeping it from being re-designated a category X drug is studies showing that the drug provides no benefit to outweigh the Topamax side effects. This could happen should additional research reveal a stronger correlation between Topamax and birth defects, and if so, it may trigger a Topamax recall.

In the meantime, in 2008 the FDA began considering completely revising its pregnancy category system. The new rule would do away with the category A-X format that currently exists and supplant it with:

[A] summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling would also include relevant clinical information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation.

The thinking behind the proposed rule is to create “consistent format” for providing information to women and physicians.

The Topamax lawyers of the Rottenstein Law Group have no opinion on the proposed rule change, but knowing that the FDA thinks Topamax warrants the second most dangerous pregnancy category makes us pause. If you took Topamax and gave birth to a baby with birth defects such as cleft lip or palate, you may be eligible for the amount of compensation relative to the harm you suffered. Contact us for a free consultation by clicking on this link or by completing our contact form to the right.