Thomas Guttuso Jr., MD, hopes to expand on a pilot study showing that the anti-seizure drug gabapentin mitigates against extreme morning sickness.
Finding a Potential Treatment for Severe Morning Sickness
Published January 22, 2013 This content is archived.
Story by Alexandra Edelblute
Pregnant women with hyperemesis gravidarum—the rare and debilitating morning sickness that afflicted Kate Middleton—notably benefit from the anti-seizure drug gabapentin, according to a small pilot study conducted by Thomas Guttuso Jr., MD.
“After two weeks of gabapentin therapy, the seven women in the study experienced an average 80 percent reduction in their nausea and a 94 percent reduction in their vomiting,” says Guttuso, assistant professor of neurology.
Small Study Yields Significant Results
Between 2008 and 2009, Guttuso ran an open-label pilot study to evaluate the safety, tolerability and effectiveness of gabapentin for hyperemesis gravidarum.
Women with the condition often retch every 15 to 30 minutes and experience severe dehydration from persistent nausea and vomiting, he explains.
Although the seven study participants had not seen any improvement with other anti-emetic medications, they dramatically improved with gabapentin.
“Within two hours of taking the first pill, most of the patients were feeling much better, and several were able to start eating and drinking again,” Guttuso says.
“It was really exciting to see how quickly the women responded.”
On average, the participants needed to take gabapentin until about halfway through their pregnancies, according to Guttuso’s findings, published in Early Human Development.
Questioning Gabapentin’s Safety in Pregnancy
In 2011 the Food and Drug Administration placed Guttuso’s pilot study on clinical hold when congenital defects were found in two of the study participants’ babies.
He was allowed to resume his research in 2012 after the FDA reviewed data from pregnancy registries reporting that infants with prenatal gabapentin exposure had about the same rate of congenital defects as the general population.
Larger Study Needed
Guttuso hopes to continue his research in a placebo-controlled study with a larger pool of patients and enrolling sites at UB and the University of Rochester. He plans to submit a grant proposal to the National Institutes of Health.
“This is a study that really needs to be done because currently there are no effective treatments,” he says.
Fifteen percent of women with the condition have abortions out of desperation for relief, he notes.
“I think a lot of people don't appreciate just how sick and disabled these women can be.”
Studying Other Roles for Anti-Seizure Drug
Guttuso previously studied gabapentin in cancer patients receiving chemotherapy.
He wanted to study the drug’s effect on hyperemesis gravidarum when he observed marked improvements in chemotherapy-induced nausea and vomiting in patients who had failed treatment with conventional anti-emetics.
His interest in gabapentin was initially sparked when he accidentally discovered that it appeared to successfully treat hot flashes in postmenopausal women.