Study finds Epilepsy Drug Harmful to Pregnant Women

In a recent study, detailed here in the LA Times, doctors in the UK found that women taking Topiramate, sold in the US by Johnson and Johnson under the name, Topomax, can lead to serious birth defects if the users are pregnant when taking the drug. Topiimate is a common drug used to control seizures and often given to those who suffer from migraines. Of the 203 women tested, it was found that chances for a birth defect was increased by 14-fold.

Of the 203 pregnancies in the test, there were two still births, five induced abortions, and 18 pregnancies that ended in spontaneous abortions. Of the 178 babies born, there were also 16 infants who suffered from major birth defects.

Doctors current suggestions for users was to stop taking the drug if the use is for treating migraines, but continue to use the drug if epilepsy is the reason for use, as seizures be harmful to the fetus.

New Law Could Affect Perscription Labeling for Pregnant Women

In a recent article at ABC News, they shed light on the FDA’s proposal to change the labeling of drugs in order to provide more information on the effects on pregnant and nursing women.

This new law would require two extra categories on the drug label: pregnancy effects and lactation effects. The pregnancy category would detail the health effects of that drug on the baby, and the lactation category would give the effects on the milk produced by the mother. However, on average, a pregnant woman takes three to five medications a day, so this could interfere with their current medication schedules.

Doctors were in favor of the decision, as they would become more educated on the effects, as well as be able to help expecting mothers with their questions on the medication they are taking.

"As a pediatrician, I frequently am asked about the safety of various medications by mothers and mothers to be," said Dr. Phil Fischer, medical director at the Mayo Clinic's Mayo Eugenio Litta Children's Hospital in Rochester, Minn. "The new FDA rules should help ensure that understandable information is readily available to physicians and to patients and families."