Directory of Drugs: Captopril - Capoten
FDA ALERT [06/2006]: Blood pressure medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) may be associated with increased risk of birth defects if taken during early pregnancy (first three months, or first trimester).
On June 8, 2006, the New England Journal of Medicine published an article reporting a study that showed babies whose mothers had taken an ACE inhibitor during the first three months of pregnancy had an increased risk of birth defects. The number of birth defects was small, and the study has not been repeated.
Before this study, it was known that ACE inhibitors can harm an unborn baby when taken during the last six months of pregnancy (second and third trimester).
If you are pregnant or planning to become pregnant and take a blood pressure medicine, talk with your healthcare professional. High blood pressure is a condition that needs treatment. Your healthcare professional can advise you on the blood pressure medicine that is best for you and your baby during pregnancy.
What are ACE inhibitors?
ACE inhibitors include: Benazepril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik).
There is a list of prescription ACE Inhibitor medicines available at:
Who Should Not Take ACE inhibitors?
If you are pregnant or planning to become pregnant and take a blood pressure medicine, talk with your healthcare professional. ACE inhibitors can harm or even cause death to an unborn baby (fetus) if taken during the last six months of pregnancy
What are The Risks?
The following are the major potential risks and side
The most common side effects with ACE inhibitors are:
What Should I Tell My Healthcare Professional?
Before you start taking an ACE inhibitor, tell your healthcare professional if you:
If you are already taking an ACE inhibitor, tell your health care professional if you
Can other Medicines or Food Affect ACE inhibitors?
ACE inhibitors and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them with you to show your healthcare professional
Date created: June 7, 2006FDA ALERT [06/2006]: On June 8, 2006, the New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitor) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated (see below for more information about the study). The study also found pregnancies with exposureAccording to ACE inhibitors beyond the first trimester. Per approved labels, ACE are currently inhibitors are labeled as pregnancy category C for the first trimester of pregnancy and have are pregnancy category D during the second and third trimesters. The existing prescribing information recommends discontinuing the ACE inhibitors as soon as possible if a patient becomes pregnant. The FDA does not plan to change the pregnancy categories at this time. However, healthcare professionals should take these findings into consideration with other information about a patient’s medical situation when prescribing ACE inhibitors.
Potential major congenital defects were identified from birth and death certificates and hospitalizations, and then analyzed by reviewers blinded to maternal prescriptions. Of the types of defects identified, half were various cardiac septal defects, and the other half included some defects of the central nervous, urologic, or other systems. The mothers on ACE inhibitors were on average older and more likely to have other chronic conditions than were the mothers not taking any antihypertensive drugs. The investigators restricted their observations to infants whose mothers met study criteria for no diabetes, though the protocol definition might not have excluded all such patients. The study also found pregnancies with exposure to ACE inhibitors beyond the first trimester.
See William O. Cooper, Sonia Hernandez-Diaz, Patrick G. Arbogast, Judith A. Dudley, Shannon Dyer, Patricia S. Gideon, Kathi Hall, and Wayne A. Ray. "Major congenital malformations after first-trimester exposure to ACE inhibitors." New England Journal of Medicine, volume 354 number 23, pages 2443-2451. June 8, 2006. This study was supported in part by the FDA (FDA 221-02-3003).
ACE inhibitors include Benazepril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik).
Date created: June 7, 2006
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