Adverse Events is a heath-tech start-up so new, they barely exist. Despite that, they’re getting some major results. This week they announced that they found from their early analysis – of the FDA’s own data – that two epilepsy drugs may be more dangerous in pregnancy than their FDA labeling might suggest. They used the FDA’s adverse event reporting data to compare the adverse events of commonly prescribed epilepsy drugs in pregnancy. What they found was that the FDA’s own labeling wasn’t consistent with their data.
Currently, the FDA classifies drugs used during pregnancy as being anywhere on a scale of safety from class A (“no known risk”), through levels of increasing risk labelled B, C, D, and then one final class X (“danger – do not use”). Specifically, Adverse Events found that two drugs, Lamictal and Keppra, which are Class C, may be “as dangerous to a fetus as drugs currently listed” in a more risky category (D).
In fact, Adverse Events’ analysis showed that an average birth defect rate comparison between the two groups, C and D, revealed no meaningful differences between the two. This scrappy little start-up’s analysis of the FDA’s own data may indicate that the FDA’s current categorization of pregnancy risks for epilepsy drugs may need revision. Or may be subject to bias.