Anapafseos 5 . Agios Nikolaos
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. C
Animal 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).
Studies, 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:
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
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.