Is Lotrel Safe During Pregnancy?
For people who are pregnant, Lotrel®
hydrochloride and amlodipine
besylate) is not recommended. This is because during pregnancy, Lotrel can lead to temporary or permanent problems, including death, in the unborn child.
Lotrel and Pregnancy Category D
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Lotrel is considered to be a pregnancy Category D medicine by the FDA. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in studies. However, a pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that its benefits outweigh the possible risks to the unborn child.
What Is the Risk of Using Lotrel During Pregnancy?
Prior to 2006, there was a common belief among healthcare providers that problems with Lotrel and pregnancy were generally seen when the drug was taken during the second or third trimester
of pregnancy. However, that changed when a study by researchers at Vanderbilt University was published in the June 2006 edition of the New England Journal of Medicine
. This study showed that there may, in fact, be an increased risk to the fetus if it is exposed to medicines like Lotrel during the first trimester
Some of the complications seen with fetuses or newborns exposed to Lotrel during pregnancy include:
- Low blood pressure (hypotension)
- Developmental problems with the nervous system
- Developmental problems with the cardiovascular system (this includes the heart and/or blood vessels)
- Developmental problems with the lungs
- Kidney failure
- Deformities of the head and face