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Statin Drug Birth Defects

The U.S. National Institutes of Health found that the use of Statins during the first trimester of pregnancy is linked to severe CNS (central nervous system), birth defects and deformed limbs. The New England Journal of Medicine says that 20 of 52 babies exposed to Statins inside their mother's wombs were born with malformed limbs. Up to 5 percent of the prescriptions for statin medications in a recent sample were for women in their childbearing years.

"We can't tell whether the defects were caused by the use of Statin medications, but other birth defect studies suggest that these are the kinds of problems that occur if the embryo does not get enough cholesterol in early pregnancy to develop normally," according to Dr. Maximilian Muenke, senior investigator and chief of the medical genetics branch at the National Human Genome Research Institute in Bethesda, Md.

Tracing the cause of birth defects in mothers taking statins proves challenging, as women don't understand the need to report early-pregnancy Statin exposure. Twenty babies were born malformed, five of those had serious central nervous system defects, and five had malformed limbs. One baby had both, according to Muenke. There were rare birth defects called holoprosencephaly, caused when the developing brain fails to divide into two hemispheres. "These are such very rare birth defects that one would not expect to find the number we found in a population this small," Muenke said.

Dr. Nancy Green, medical director for the March of Dimes said, "Statins are very good for general health. But there's a lot we don't know about their safety in pregnancy because there is no national system for monitoring the safety of drugs during pregnancy. About half of all pregnancies are unplanned, so exposure to dangerous statin drugs can happen before a woman even knows she's pregnant."