In studies on Anzemet and pregnancy, the medication did not cause any problems when it was given in high doses to pregnant rats. However, animals do not always respond to drugs the same way that humans do. Anzemet should only be given to pregnant women if the benefits outweigh any possible risks to the unborn child. In addition, the medicine is not recommended for long-term use.
Anzemet and Pregnancy: An Overview
Anzemet® (dolasetron mesylate) is a prescription nausea and vomiting medication. It is approved to be used temporarily or intermittently for nausea and vomiting due to surgery or chemotherapy. It is not approved to treat nausea and vomiting related to pregnancy. While Anzemet appears to be safe for temporary or short-term use in pregnancy, it is not recommended for long-term use.
Anzemet and Pregnancy Categories B
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. Pregnancy Category B is given to medicines that have not been studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
Anzemet has been studied at high doses in pregnant rats without causing any problems. However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
Anzemet should not be used to treat nausea and vomiting associated with pregnancy. Anzemet has never been studied for long-term use. It is not known if Anzemet has any long-term side effects, and it not known if the drug is safe when used in such a manner.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Anzemet [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC;2013 September.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed July 24, 2007.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 7th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2005.
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