In animal studies on Avastin and pregnancy, the drug increased the risk of miscarriages, birth defects, and low fetal weight. As a result, the FDA considers the drug to be a pregnancy Category C medication. However, since animals and humans can respond to drugs differently, if you are taking Avastin and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation.
Avastin and Pregnancy: An Overview
Avastin® (bevacizumab) is a prescription medication approved to treat various types of cancer. It may not be safe for use during pregnancy, although the full risks are not known at this time. Animal studies have suggested that Avastin may cause problems when used in pregnant women.
In late 2010, the United States Food and Drug Administration (FDA) recommended that Avastin's breast cancer approval be removed. Studies have not shown the drug to increase survival in people with breast cancer, and there is not sufficient benefit to outweigh the risks.
This action does not affect Avastin's approval for other uses. Healthcare providers may still use Avastin to treat breast cancer, although they will be doing so in an "off-label" fashion.
Avastin and Pregnancy Category C
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to rabbits, Avastin increased the risk of miscarriages, birth defects, and low fetal weight. The drug works by inhibiting the growth of new blood vessels. New blood vessel growth is extremely important for fetal development, and Avastin likely causes problems during pregnancy by inhibiting this blood vessel growth.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
If you are pregnant or are thinking of becoming pregnant while taking Avastin, let your healthcare provider know. He or she will consider both the benefits and risks of taking the drug during pregnancy before making a recommendation in your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Avastin [package insert]. San Francisco (CA): Genentech, Inc.;2013 January.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA begins process to remove breast cancer indication from Avastin label (12/16/2010). FDA Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm237172.htm. Accessed March 15, 2011.
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