Statins and Pregnancy

By Karen Kuehn Howell, Ph.D.

The United States Food and Drug Administration have classified cholesterol-lowering drugs, or statins, as pregnancy category X, which means these drugs are not supposed to be taken by pregnant women. Recently, some birth defects specialists are concerned about the possibility of cholesterol-lowering drugs becoming available over-the-counter to a wide range of women of child bearing age.

According to researchers with the March of Dimes, there is a hypothesized link between the use of statins during pregnancy and a set of birth defects. Although it is extremely unlikely that a doctor would prescribe a statin to a pregnant patient, a woman might unknowingly become pregnant while taking a statin.

Though it is not known whether any birth defects in babies born to women who took statins were caused by the drugs, a study published last month in the American Journal of Medical Genetics raises the possibility. The researchers looked for patterns of defects that might suggest a link to statin use. Of the 70 reports that contained enough information to assess, there were 22 cases of babies born with anatomical defects. Among those 22 cases, there were extremely rare defects consistent with those seen in experimental animals with low cholesterol and in humans with a genetic mutation that prevents proper use of cholesterol.

Researchers note, however, that determining whether statins cause birth defects will be difficult. Relatively few women take statins during pregnancy, although as the March of Dimes notes, increasing maternal ages and widespread public recognition of statins may increase the likelihood of pregnancy and statin use.
It will be some time before researchers will be able to provide a meaningful analysis of the risks of statins in pregnancy. Until then, all pregnant women are urged to avoid the use of cholesterol-lowering drugs such as statins.

The Maternal Substance Abuse and Child Development Project is funded in part by the Georgia Department of Human Resources Division of Public Health.

The Maternal Substance Abuse and Child Development Study is under the direction of Claire D. Coles Ph.D., with the Department of Psychiatry and Behavioral Science, Emory University School of Medicine. For more information, please contact: Claire D. Coles: ccoles@emory.edu Karen K. Howell: khowell@emory.edu