Frågedatum: 29.10.1999
RELIS database ; id.nr. 16106, DRUGLINE
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A woman pregnant at week 7 has been treated with Lipitor (atorvastatin) during the pregnancy. Is th



Fråga: A woman pregnant at week 7 has been treated with Lipitor (atorvastatin) during the pregnancy. Is there any indication for abortion?

Sammanfattning: Based on animal data, limited human experience and some reported cases of malformations, the use of HMG-CoA reductase inhibitors is recommended to be avoided during pregnancy. However, the exposure to these drugs cannot be considered as an indication for abortion. No documentation concerning specifically the compound atorvastatin has been found in the literature. The case should be followed up and the outcome of the pregnancy reported.

Svar: Atorvastatin is an HMG-CoA reductase inhibitor used in the treatment of hyperlipidemia. Atorvastatin is in FASS classified in group D with respect to use during pregnancy (1), ie a drug that in man has given or can be expected to give an increased risk of malformations or other forms of damage to the fetus.<br><br>A literature search has revealed no information about the use of atorvastatin during pregnancy. With respect to other HMG-CoA reductase inhibitor, infants with malformations following in utero exposure to lovastatin have been described in published and unpublished reports, but the causal-relationship between the drug and the effects cannot be determined (2). Exposure to simvastatin during early pregnancy appears not to present a significant risk to the fetus (3). However, because the interruption of cholesterol-lowering therapy during pregnancy should have limited effect on the long term treatment of hyperlipidemia, it is recommended that HMG-CoA reductase inhibitors should not be used during pregnancy (3).<br><br>Outcome data from 28 pregnancies where the mother was exposed to HMG-CoA reductase inhibitors during the first trimester are available at the Swedish malformation register (4). None of these was related to the use of atorvastatin. Among these, there were in total four cases of malformations including two different types of cardiac malformations, one case of polydactylia, and one case of Downs syndrome. According to professor Bengt Källen there is thus no evidence of an increased risk of malformations and that an early exposure to HMG-CoA reductase inhibitors is not an indication for abortion.<div id="referenser" style="display:none;">1 FASS 1999, page 764-765 (The Swedish catalogue of approved medical products)<br>2 Briggs GB, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 5th ed. Baltimore: Williams & Wilkins; 1998. p. 630-632<br>3 Briggs GB, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 5th ed. Baltimore: Williams & Wilkins; 1998. p. 966-968<br>4 Personal communication with professor Bengt Källen, Department of Embryology, University of Lund, Sweden</div>

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