New England Journal of Medicine Alert on Statins

The April 8, 2004 issue of The New England Journal of Medicine contains a letter-to-the-editor from two physicians at the National Institutes of Health entitled, “Central Nervous System and Limb Anomalies in Case Reports of First-Trimester Statin Exposure.”  This letter raises an alert about statins, a class of prescription drugs used for lowering cholesterol.  The generic names of these drugs include atorvastatin, simvastatin, and lovastatin. Statins are being prescribed more and more commonly because more Americans are overweight and have elevated cholesterol levels, a major risk factor for cardiovascular disease.  This means that more women of childbearing age are taking these drugs and – because at least half of all pregnancies in the United States are unplanned – more women in the early months of pregnancy are inadvertently exposing their fetuses to statins.  This is a great concern to the March of Dimes.

There are already animal data showing that statins can cause birth defects when used in early pregnancy.  However, there is currently no mechanism in place by which the effects or levels of safety in pregnancy of statins or most other new drugs on the market can be studied.  The number of births after first-trimester exposure to these drugs is unknown.  The March of Dimes is working with the U.S. Centers for Disease Control and Prevention, the Food and Drug Administration, and our partners in the health professions to set up a monitoring system to collect information on the effects of new drugs on pregnancy.  Such a system would be similar to the registries or retrospective studies conducted by the California Birth Defects Monitoring Program or the Slone Epidemiology Center at Boston University.