During pregnancy, women have to be careful about what kinds of medications they take. While many are safe, some are not and working with health care providers is crucial to a successful pregnancy.
Both prescription and OTC drugs are rated for safety during pregnancy as some can pass through the placenta to the baby. While a substance might be safe for an adult, the parameters are different for a baby in utero. Some medications cannot be discontinued during pregnancy, however. Women who have epilepsy and take prescription drugs to control seizures, cannot just stop taking these drugs. It's a balancing act of managing seizures and protecting the fetus.
A common anti-epileptic drug topiramate has been prescribed for more than ten years to treat epilepsy. It's also been used to treat bipolar disorder and chronic migraines. It's been approved for weight-loss as well; however, patients who are pregnant would not be given the drug for that reason. While it's been studied and deemed safe to take during pregnancy, recent research has shown that it increases a woman's risk for having a child born with an oral cleft, usually a cleft lip, although cleft palate has been seen as well.
Doses of topiramate are highest when being given for control of epilepsy. At these amounts, there was a two to five-fold increase in the odds of having a child with a cleft lip. The study was conducted by investigators at Brigham and Women's Hospital and the Harvard T. H. Chan School of Public Health, in Boston and Cambridge, respectively. The results of their study were published in the journal of the American Academy of Neurology.
Last author Elisabetta Patorno, MD, DrPH, works on clinical research at the BWH Division of Pharmacoepidemiology & Pharmacoeconomics. She stated, "Our results suggest that the increased risk of oral clefts is most pronounced in women taking higher doses of topiramate to treat epilepsy. Low doses of topiramate may also increase the risk of oral clefts but to a lesser extent. We hope that this work gives important information to women and their clinicians as they determine the best course of treatment and options available to individuals."
The research came from leveraging big data from Medicaid archives. More than 1 million live births nationwide were tracked from the years 2000-2010. Oral cleft risk, including cleft lip and cleft palate were analyzed in three groups: Infants born to women who had taken topiramate in the first trimester of pregnancy, infants born to women who had taken lamotrigine, a drug that is unrelated to topiramate and prescribed for both bipolar disorder and epilepsy and a third group who had not used any medication for epilepsy, migraines or mental illness.
The normal incidence of babies born with oral clefts is one out of every 1,000 births. Among infants born to mothers who had taken a low dose (100mg per day) of topiramate, the risk was calculated at 2.1 births per 1,000. When calculating risk for women who took a higher dose of 200 mg, the risk went up to a whopping 12.3 per 1,000 births. While the medication is necessary for women who have epilepsy, dosing is important to consider.