Advicor and Pregnancy

There are some potential dangers involved with taking Advicor, and pregnancy risks are a serious issue. This drug, which is a pregnancy Category X medicine, can potentially cause harm to a fetus. Therefore, if you become pregnant while taking Advicor, be sure to talk to your healthcare provider -- use of the drug is not recommended.

Pregnancy and Advicor: An Overview

Advicor® (niacin extended-release/lovastatin) is a pregnancy Category X medicine, meaning that the medicine could potentially cause harm to your unborn child. Therefore, this drug is not recommended in women who are pregnant. If you are pregnant or thinking about becoming pregnant, talk to your healthcare provider right away.
 

Advicor and Pregnancy Category X

The U.
 S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when specific medicines are taken during pregnancy. Category X is given to medicines that show problems to the fetus in animal studies or in humans that have taken the medicine while pregnant. The use of a Category X medicine during pregnancy is not recommended.
 
Advicor contains two different medications: extended-release niacin (Niaspan®) and lovastatin (Mevacor®). Advicor received a pregnancy Category X rating due to the lovastatin component. Giving lovastatin to pregnant mice and rats produced skeletal malformations, but only at extremely high dosages. Other problems seen in rats included :
 
  • Decreased survival in the newborns
  • Slow weight gain in the newborns
  • Delayed development in the newborns.
 
There have been occasional reports of problems such as miscarriages or birth defects in humans that take statins (such as lovastatin), but it does not appear that statins actually increase the risks of such problems (a certain number of miscarriages and birth defects will occur during pregnancies, even if no medications are taken).
  
(Advicor and Pregnancy Continued: Page 2)
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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