Fetal Risk

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How To Use Site?

Dear Health Care Professionals,

Fetalrisk.com is a medical website containing information about pregnancy risk categories of medicinal products of human use and herbal medicinal products.

Fetalrisk.com website gives you information about most commonly known and used three pregnancy risk classification systems in the world. These three systems are:

1. "USA Classification System" created by US Food and Drug Administration/FDA,

2. "Australia Classification System" created by Australian Drug Evaluation Committee/ADEC and revised by Australian Advisory Committee on Prescription Medicines/ACPM in 2011.

3. "German Classification System" created by the German health authority and located in ROTE LISTE which is the official pharmacopoeia of Germany.

Pregnancy risk categories of the drugs are classified as "A, B, C, D, X" in the US system; "A, B1, B2, B3, C, D, X" in the Australian system; and "Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8, Group 9, Group 10 and Group 11" in Germany system.

FDA has eliminated the use of pregnancy risk category in the package leaflet of the new licensed products by a decision taken at the beginning of December 2014. This decision will be implemented from June 30, 2015. Therefore, the United States "A, B, C, D and X" pregnancy risk categories on the website are the categories of the old classification system.

When you search any drug substance using the search box located on the home page of our website, the pregnancy risk categories based on three different countries and description of the drugs containing the drug substance will appear at the same time. In this way, it is intended to achieve a current, reliable and approved risk and safety information for the drug which is considered to be used during pregnancy. On our website, pregnancy risk category information of approximately 7500 different drug substances belonging to the most common prescribed drugs for the purpose of diagnose, treatment and prevention in routine clinical practice is located.

While searching drug substance on our website, description of statements next to the drug substance is shown below:

"Informal / Expert Opinion"
This drug is not available in the United States or has not been evaluated and officially categorized by the FDA. This category is given informally by experts based on by various analyzes and experience, not by FDA.

"Informal / Manufacturer Company"
This drug is not available in the United States or has not been evaluated and officially categorized by the FDA. This category is given informally by manufacturer developing, producing or marketing this drug based on by various analyzes and experience, not by FDA.

“CIP”
Contraindicated In Pregnancy.

“CIP / Rote Liste®”
This drug is contraindicated in pregnancy according to the ROTE LISTE which is the official pharmacopoeia of Germany.

“CIP / Manufacturer Company”
This drug is contraindicated in pregnancy according to manufacturer developing, producing or marketing this drug.

“CIP / Expert Opinion”
This drug is contraindicated in pregnancy according to "Expert Opinion" based on various scientific analysis or clinical experience.

"The numbers in brackets (1-11)"
As drug substance in German classification system can be located in more than one category, such drug substances are indicated separately and each category of Rote Liste by numbers in brackets.

“Herbal”
This drug has herbal origin. In order to avoid the potential failure and the confusion in the name of herbal origin drug substance, only Latin scientific name or names in the medical literature are used; not different regional names of these herbs in our country.

“FDA-USA”
It is a statement specified for drug use in pregnancy in the package leaflet of licensed drugs in the United States. This statement has been created as a result of the evaluations by the US Food and Drug Administration (FDA). The statements in accordance with the new decision taken by the FDA in 2014 are used in this drug.

“EMA-EUROPA”
It is a statement specified for drug use in pregnancy in the package leaflet of licensed drugs in the countries of the European Union. This statement has been created as a result of the evaluations by the European Medicines Agency (EMA).

“JAPAN”
It is a statement specified for drug use in pregnancy in the package leaflet of licensed drugs in Japan. This statement has been created as a result of the evaluations by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).