Reported Adverse Drug Reaction Cases
Statins contraindicated in pregnancy
The Australian Drug Evaluation Committee (ADEC) has recently changed the pregnancy classification of the statins (atorvastatin, Lipitor; fluvastatin, Lescol, Vastin; pravastatin, Pravachol; simvastatin, Lipex, Simvar, Zocor) from category C to category D (see box). The statins were already contraindicated in pregnancy and the change follows publication of a series of cases of fetal malformation including effects on the central nervous system and limb abnormalities associated with first trimester exposure to a statin.1 Cholesterol and other steroids are essential to fetal development including the formation of cell membranes, and the adverse effects of statin exposure during pregnancy may not be reversible.
Women contemplating pregnancy should not be taking a statin, and women becoming pregnant while taking a statin should discontinue it immediately.
Category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
Australian Adverse Drug Reactions Bulletin
Volume 24, Number 1, February 2005