Study title and authors:
Central Nervous System and Limb Anomalies in Case Reports of First-Trimester Statin Exposure
Robin J. Edison, M.D., M.P.H. Maximilian Muenke, M.D.
National Institutes of Health Bethesda, MD 20892-1852
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This paper can be accessed at: http://www.nejm.org/doi/pdf/10.1056/NEJM200404083501524
The paper reviewed 52 cases of first-trimester statin exposure
reported to the Food and Drug
Administration (FDA).
The review found:
(a) Among these cases, there were 20 reports of malformation, including 5 severe defects of the central nervous system (2 of which were holoprosencephaly) and 5 unilateral limb deficiencies.
(b) One patient had both of these malformations. The two simvastatin-exposed cases of limb deficiency were complex lower-limb anomalies including both long-bone shortening and aplasia or hypoplasia of the foot structures. The infant in one of these cases and a lovastatin-exposed infant also had rare forms of the VACTERL association (i.e., three or more of the following findings: vertebral, anal, cardiac, tracheal, esophageal, renal, and limb defects).
(c) It is thought that only a small proportion of statin adverse events are reported to the FDA.
(d) There would be no expected cases of most of the malformations listed in the paper; yet three rare anomalies are each observed twice.
Dr Edison concludes that these findings support the need for controlled studies evaluating the potential birth defects effects of statin drugs.
More information on this subject: Books reported to the Food and Drug Administration (FDA). The review found:
(a) Among these cases, there were 20 reports of malformation, including 5 severe defects of the central nervous system (2 of which were holoprosencephaly) and 5 unilateral limb deficiencies.
(b) One patient had both of these malformations. The two simvastatin-exposed cases of limb deficiency were complex lower-limb anomalies including both long-bone shortening and aplasia or hypoplasia of the foot structures. The infant in one of these cases and a lovastatin-exposed infant also had rare forms of the VACTERL association (i.e., three or more of the following findings: vertebral, anal, cardiac, tracheal, esophageal, renal, and limb defects).
(c) It is thought that only a small proportion of statin adverse events are reported to the FDA.
(d) There would be no expected cases of most of the malformations listed in the paper; yet three rare anomalies are each observed twice.
Dr Edison concludes that these findings support the need for controlled studies evaluating the potential birth defects effects of statin drugs.
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