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The Food and Drug Administration lists antibiotics in categories based on safety for use during pregnancy. It has established five categories to indicate the evidence and the potential of a drug to cause birth defects if used during pregnancy. The categories are determined by the reliability of documentation and the risk to benefit ratio. They do not take into account any risks from pharmaceutical agents or their metabolites in breast milk.
The categories are: The categories are A, B, C, D and X.
CATEGORY DEFINITION COMMENTS A Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities. Drugs that fall under category A have had several well-controlled studies that found no harmful effects or increase in birth defects. These drugs have all had studies conducted in pregnant woman with positive results. Very few drugs fall into this category. Prenatal vitamins receive a category A rating. B Animal studies have revealed no evidence of harm to the fetus, however 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. Drugs assigned a category B rating are not likely to pose a threat to the fetus from the evidence in animal studies, but no well-controlled studies have been performed in pregnant women. However, a drug may also receive a category B rating if animal studies have shown evidence of fetus damage but the same drug tested on pregnant women posed no threat. CAnimal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. Or, no animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
A category C rating is given to drugs that have been shown to be harmful in animal studies but no studies have been conducted on pregnant humans. Drugs may also receive a category C rating if the drug was not studied in animals and there isn't enough evidence from studies in pregnant humans. This implies that the drug may or may not be safe to take.
D Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.Drugs receive a category D rating when the drugs have been tested in well-controlled or observational (not controlled) studies, which resulted in harm to the unborn baby. In some cases these drugs may still be given if the benefits to the mother outweigh the risks to the baby (for example, cancer treatment).
XStudies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.
A Category X rating is assigned to drugs that should never be used during pregnancy, as there are no benefits that would exceed the potential risk.Using Antibiotics During Pregnancy
According to doctors and researchers, a few guidelines should be followed before prescribing an antibiotic to a pregnant patient. These include:
Only use antibiotics if no other treatment option will suffice.
Avoid prescribing antibiotics during the first trimester when possible.
Choose a safe medication (typically an older antibiotic tested on pregnant women).
Choose single prescriptions over polypharmacy when possible.
Dose at the lowest possible amount proven effective.
Advise patients not to use over the counter medications during antibiotic treatment.
Antibiotics Generally Considered Safe for Use During Pregnancy
Some of the common infections during pregnancy that require antibiotic treatment include urinary tract infection, bladder infection, pyelonephritis and appendicitis. This is not a complete list of infections that require antibiotic treatment.
If your physician prescribes an antibiotic for use during pregnancy, it is extremely likely that the drug falls into either Category A or Category B on the FDA list of approved drugs for use during pregnancy. Some of the antibiotics that may be prescribed safely during pregnancy include:
Amoxicillin
Ampicillin
Clindamycin
Erythromycin
Penicillin
Gentamicin
Ampicillin-Sulbactam
Cefoxitin
Cefotetan
Cefazolin
Clinical Information and New Antibiotics
There is very little clinical information on the effect of new antibiotics on pregnancy and fetal complication risk. Decades ago, pregnant women were allowed to participate in drug testing so older antibiotics are typically the first prescribed by obstetricians. However, in some cases, despite the lack of formula testing during pregnancy, obstetricians are faced with a risks versus benefits case. If the benefits of prescribing an antibiotic during pregnancy outweigh the potential risks, the antibiotic in question is chosen.
There are several antibiotics safely prescribed during pregnancy. If you have an infection and your obstetrician has prescribed an antibiotic, talk with your doctor about the possible risks of taking the medication. In some cases, as is the case with urinary tract infections, leaving the infection untreated poses a risk to the pregnancy and unborn fetus.
Medicine and Pregnancy
https://www.fda.gov/forconsumers/byaudience/forwomen/ucm118567.htm
En Español, In Chinese, In French, In French Creole
Are you pregnant and taking medicines? You are not alone. Many women need to take medicines when they are pregnant. There are about six million pregnancies in the U.S. each year, and 50% of pregnant women say that they take at least one medicine. Some women take medicines for health problems, like diabetes, morning sickness or high blood pressure that can start or get worse when a woman is pregnant. Others take medicines before they realize they are pregnant.
Pregnancy can be an exciting time. However, this time can also make you feel uneasy if you are not sure how your medicines will affect your baby. 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 four (4) tips to help you talk to your healthcare provider about how prescription and over-the-counter medicines might affect you and your baby.
Bonus Tip: Help spread the word about pregnancy safety.
1. Ask Questions.
Always talk to your healthcare provider before you take any medicines, herbs, or vitamins. Don't stop taking your medicines until your healthcare provider says that it is OK.
Use these questions to help you talk to your doctor, nurse, or pharmacist:
Will I need to change my medicines if I want to get pregnant? Before you get pregnant, work with your healthcare provider to make a plan to help you safely use your medicines.
How might this medicine affect my baby? Ask about the benefits and risks for you and your baby.
What medicines and herbs should I avoid? Some drugs can harm your baby during different stages of your pregnancy. At these times, your healthcare provider may have you take something else.
Will I need to take more or less of my medicine? Your heart and kidneys work harder when you are pregnant. This makes medicines pass through your body faster than usual.
Can I keep taking this medicine when I start breastfeeding? Some drugs can get into your breast milk and affect your baby.
What kind of vitamins should I take? Ask about special vitamins for pregnant women called pre-natal vitamins.
Pre-Natal Vitamins
Some dietary supplements may have too much or too little of the vitamins that you need. Talk to your healthcare provider about what kind of pre-natal vitamins you should take.
What is folic acid? 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
Check the drug label and other information you get with your medicine to learn about the possible risks for women who are pregnant or breastfeeding. The labeling tells you what is known about how the drugs might affect pregnant women. Your healthcare provider can help you decide if you should take the medicine.
Find information on a specific drug
New Prescription Drug Information
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.
3. Be Smart Online.
Ask your doctor, nurse, or pharmacist about the information you get online. Some websites say that drugs are safe to take during pregnancy, but you should check with your healthcare provider first. Every woman's body is different. It may not be safe for you.
Do not trust that a product is safe just because it says 'natural'.
Check with your healthcare provider before you use a product that you heard about in a chat room or group.
Online Resources
4. 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 to Report to FDA
You should report problems like serious side effects, product quality problems and product use errors. Report problems with these products:
human drugs
medical devices
blood products and other biologics (except vaccines)
medical foods
Learn more about reporting problems to FDA.
Sign Up for a Pregnancy Registry
Pregnancy Exposure Registries are research studies that get information from women who take prescription medicines or vaccines during pregnancy. Pregnancy registries help women and their doctors learn more about how medicines can be safely used during pregnancy.
Help other pregnant women. Share 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.
Pregnancy Social Media Toolkit
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. The toolkit includes resources for pregnant women and health professionals, including sample social media messages and blog posts.
Download and Share: Social Media Toolkit (PDF 166KB)
To Learn More
- Get Information about a Specific Drug
- Use of Codeine and Tramadol Products in Breastfeeding Women - Questions and Answers
- Pregnant? Breastfeeding? Better Drug Information Is Coming
- Registries Help Inform Medication Use in Pregnancy
- Pregnancy: A Time for Special Caution
- MotherToBaby - Provides counseling to patients and health care professionals about medicines used during pregnancy and breastfeeding.
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