MIGRAINE DRUG POSES AN ORAL CLEFT RISK
MIGRAINE DRUG POSES AN ORAL CLEFT RISK Dental hygienists should keep an eye on medical histories for an important red flag that may emerge in the records of female patients in their childbearing years. The U.S. Food and Drug Administration
MIGRAINE DRUG POSES AN ORAL CLEFT RISK
Dental hygienists should keep an eye on medical histories for an important red flag that may emerge in the records of female patients in their childbearing years. The U.S. Food and Drug Administration (FDA) has issued a warning about the potential for oral clefts in children born to women who take Topamax (topiramate) during their first trimester of pregnancy. Topamax is a drug prescribed most frequently to treat migraine headaches, but is also used to treat epilepsy, bipolar disorder, and to offset weight gain triggered by antidepressants.
The FDA issued a statement earlier this month to neurology, obstetrics and gynecology health care workers that advised Topamax is now classified in Pregnancy Category D—a move that indicates the drug is connected to positive evidence of human fetal risk. The new classification acknowledges that the risk of using Topamax may be acceptable, however, due to the potential benefits to pregnant women who use the drug.
Practitioners should also be aware topiramate can reduce the effectiveness of birth control pills; therefore, women who take the drug and do not wish to become pregnant should discuss how to optimize birth control with their health care professional. “Alternative medications that have a lower risk of birth defects should be considered,” notes Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA moved Topamax to the higher risk classification after data released by the North American Antiepileptic Drug Pregnancy Registry demonstrated the risk of oral clefts in a developing fetus escalates when the drug is taken during the first trimester of pregnancy. It is not uncommon for some women to be unaware they are pregnant during the first trimester. The FDA emphasizes that women who take topiramate should not stop taking the drug even if they become pregnant without first consulting a health care professional.
Source: U.S. Food and Drug Administration
