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MEDICINES DURING PREGNANCY

When prescribing a medicine to a pregnant woman, not only should be considered potential adverse effects that can cause directly to the patient, but also to the fetus

unfortunately not always it is possible to have a complete information about the undesirable effects of each and every one of the medications, both for the mother and the unborn child, as there are limits that must not be exceeded in clinical trials, so that in many cases it is not possible to predict the consequences of the administration of a particular drug.

This means that one should always act under the principle of maximum prudence, taking into account the uncertainty caused by scarce medical knowledge available about the use of medications during pregnancy.

 

MEANING OF CATEGORIES

Category A

Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Specialties Listings     

These pages contain lists of authorized medicines in various countries listed below:

[ Australia ] [ Brazil ] [ Canada ] [ France ] [ Germany ] [ India ] [ Italy ] [ Japan ] [ Korea ] [ Mexico ] [ Puerto Rico ] [ Spain ] [ Turkey ] [ United Kingdom ] [ U.S.A. ]

Given the nature of the pharmaceutical market, some specialties may not be sold, have been suspended or had its name changed or ended, so that in no case can take decisions based on the information contained in the page. MEDIZZINE not responsible for any damages arising from the information provided, which may be incomplete or outdated.

Temporarily may be not available trade names of certain active ingredients.

WARNING ABOUT THE CONTENTS
This page provides information to clarify some basic questions about the use of drugs in relation to driving. It is not exhaustive and, therefore, does not expose all of the available information and does not replace the information that you can provide your doctor, who must ultimately address to answer your questions.