FDA Pregnancy Risk Categories Prior to 2015. In 1979, the FDA established five letter risk categories - A, B, C, D or X - to indicate the potential of a drug to cause birth defects if used during pregnancy. The categories were determined by assessing the reliability of documentation and the risk to benefit ratio.
| Drug name | FDA pregnancy risk classification by trimester (1st/2nd/3rd) | Drug class |
|---|---|---|
| Acetaminophen (Tylenol) | B/B/B | Non-narcotic analgesic/antipyretic |
| Aspirin | D/D/D | Salicylate analgesic/antipyretic |
| Ibuprofen (Advil, Motrin) | B/B/D | NSAID analgesic |
| Ketoprofen (Orudis) | B/B/D | NSAID analgesic |
What are the categories of pregnancy?
- Med ART Studios
- Ovia Health
- Mobile Dimension LLC.
- Preglife
- Philips Consumer Lifestyle B.V
- BabyCenter, L.L.C.
- HelloBaby, Inc.
- Flo Health, Inc. ● the Asianparent Group
- WebMD LLC
- Totali Inc.
What are the pregnancy risk categories?
- Pregnancy Testing
- Contraception
- Infertility
What are pregnancy safety categories?
- birth defects
- unwanted pharmacological effects around the time of birth, which may or may not be reversible
- problems in later life
What are the categories of drugs in pregnancy?
Pregnancy (Labor & Delivery) Lactation (Nursing Mothers) Females & Males of Reproductive Potential; The old pregnancy drug categories until 2016. Category A: Adequate studies inpregnant women have not demonstrated a risk to the fetus in the first trimester, and there is no evidence of risk in later trimesters. The possibility of fetal harm ...
What are FDA pregnancy risk categories?
In 1979, the FDA established five letter risk categories - A, B, C, D or X - to indicate the potential of a drug to cause birth defects if used during pregnancy.
What is FDA Category B pregnancy?
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.
What is FDA category C pregnancy?
C. Animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies of humans. The benefits from the use of the drug in pregnant women might be acceptable despite its potential risks.
What are Category D drugs in pregnancy?
Category D: There is positive evidence of potential fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (i.e. life-threatening condition to mother).
What are Category D drugs?
Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
What is a Class B medication?
Class B. Class B drugs are considered by Parliament to be less harmful than Class A drugs and include amphetamines, barbiturates, cannabis and dihydrocodeine. Certain Class B drugs are reclassified to Class A if they have been prepared for injection. These include amphetamines, dihydrocodeine and codeine.
What are different schedules of drugs as per the D and C Act?
Schedule T: Contains various regulations and requirements for manufacture of Ayurvedic, Siddha and Unani products. Schedule U: Contains various regulations and requirements for record keeping. Schedule W: Contains Generic Drugs List. Schedule Y: Contains requirement and guidelines for clinical trials.
What pregnancy category is Zofran?
The FDA has classified Zofran as a “Pregnancy Category B” drug, meaning that it has not been the subject of any well-controlled studies to determine the effects Zofran may have during pregnancy. However, the FDA has approved “Pregnancy Category A” drug called Diclegis to safely treat morning sickness in pregnant women.May 28, 2019
What is a pregnancy exposure registry?
Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. Information about the existence of any pregnancy registries in drug labeling has been recommended but not required until now.
What is the nursing mother section?
The Nursing mothers subsection was renamed, the Lactation subsection (8.2), and provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.
Category A
Adequate and well-controlled 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.
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.
Food Safety
Pregnancy makes it harder for your body to fight off illness caused by food. Some foods are not safe for you and your baby. Check out these food safety tips.
Breast Pumps and Breastfeeding
The FDA has general tips on how to safely use a breast pump and store breast milk. Talk to your healthcare provider for other breastfeeding tips.
Other Helpful Tips for New Moms
There is a lot you need to know about the medicines and other products you use for your baby. FDA has free videos and brochures to help you talk to your healthcare provider about what is best for you and your baby.
What is the FDA Office of Women's Health?
The FDA Office of Women's Health offers resources to help women and healthcare providers get informed about medicines and other products used during pregnancy. Use the Pregnancy Social Media Toolkit to inform pregnant women in your network about medication safety.
What is a pregnancy exposure registry?
Pregnancy Exposure Registries are research studies that get information from women who take prescription medicines or get a vaccine during pregnancy. Pregnancy registries help women and their doctors learn more about how medicines can be safely used during pregnancy.
How to help other pregnant women?
Help other pregnant women by sharing your experiences with medicines. You will not be asked to take any new medicines. You will provide information about your health and your baby's health. FDA does not run pregnancy registries, but it keeps a list of registries. See if there is a registry for your medicine.
How does folic acid help with pregnancy?
Folic acid helps to prevent birth defects of the baby’s brain or spine. Ask about how much folic acid you should take before you become pregnant and through the first part of your pregnancy. 2. Read the Label.
How to report a problem with a prescription?
Report Problems. First, tell your healthcare provider about any problems you have with your medicine. Also , tell FDA about any serious problems you have after taking a medicine. Call 1-800-FDA-1088 to get a reporting form sent to you by mail. Report problems online .
What are the new drug labels?
The prescription drug labels are changing. The new labels will replace the old A, B, C, D and X categories with more helpful information about a medicine's risks. The labels will also have more information on whether the medicine gets into breast milk and how it can possibly affect the baby.
Is it safe to take pain medicine while pregnant?
Not all medicines are safe to take when you are pregnant. Even headache or pain medicine may not be safe during certain times in your pregnancy. Here are tips to help you learn more about how prescription and over-the-counter medicines might affect you and your baby. Ask Questions.
Criticism
- In 2015 the FDA replaced the former pregnancy risk letter categories (see below) on prescription and biological drug labeling with new information to make them more meaningful to both patients and healthcare providers. The FDA received comments that the old five-letter system left patient…
Administration
- Prescription drugs submitted for FDA approval after June 30, 2015 will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001 will be phased in gradually. Medications approved prior to June 29, 2001 are not subject to the PLLR rule; however, the pregnancy letter category must be removed by June 29, 2018. For generic drugs, if …
Risks
- The Pregnancy subsection will provide information about dosing and potential risks to the developing fetus and registry information that collects and maintains data on how pregnant women are affected when they use the drug or biological product. Information in drug labeling about the existence of any pregnancy registries has been previously recommended but not requi…
Treatment
- The Lactation subsection will replace the Nursing Mothers subsection of the old label. Information will include drugs that should not be used during breastfeeding, known human or animal data regarding active metabolites in milk, as well as clinical effects on the infant. Other information may include pharmacokinetic data like metabolism or excretion, a risk and benefit s…
Prevention
- In the subsection entitled Females and Males of Reproductive Potential, relevant information on pregnancy testing or birth control before, during or after drug therapy, and a medications effect on fertility or pregnancy loss will be provided when available.
History
- The FDA has received requests to improve the decades-old content and format of pregnancy prescription drug labeling since 1992. According to the Drug Information Division at the FDA, they obtained input from many affected groups and held public hearings, advisory committee meetings, and focus groups to assess the changes. In 2008, the FDA issued the proposed rule a…
Society and culture
- Examples of drugs approved since June 30th, 2015 showing various new pregnancy and lactation subsections in their labels:
Side effects
- 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. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but po…