FDA wants more studies of antiseizure drug

A warning of teratogenicity, or abnormal development, isn’t enough for one antiseizure medication: the Food and Drug Administration’s (FDA) Pediatric Advisory Committee is recommending requesting more studies.

The antiseizure drug divalproex sodium (Depakote), made by Abbott Laboratories, has been linked to two cases of type 1 diabetes mellitus and three cases of developmental delay within a one-year period ending this March. FDA also found 10 additional claims of developmental delay over the years, according to Drug Industry Daily. The drug’s label already indicates teratogenicity, but the committee would like more study into the matter.

The Pediatric Advisory Committee is currently looking into the adverse-event reports of a dozen different drugs, including Solvay Pharmaceutical’s testosterone gel (Androgel), which it has already concluded needed more label copy to explain its risks to children.

Other drugs under the FDA committee’s eye include treatments for asthma, glaucoma, psoriasis, hypertension, hepatitis B, tonsillitis, nasal allergies, and certain types of cancer.

By: Jeff Ryan
Contemporary Pediatrics