Alexandros Sfakianakis
Anapafseos 5 . Agios Nikolaos
Crete.Greece.72100
2841026182

6948891480

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:

    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

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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.

Medicine and Pregnancy: 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.

www.fda.gov/pregnancyregistries

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

Resources for Health Professionals

Take Time to Care Program

Women's Health Topics

Resources for You

Page Last Updated: 05/19/2017

Rev Obstet Gynecol.

PMCID: PMC2760892

Antibiotics in Pregnancy: Are They Safe?

Errol R Norwitz, MD, PhD^* and James A Greenberg, MD^†

^*Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT

^†Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Division of Gynecology, Faulkner Hospital, and Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA

Author information ▼ Copyright and License information ►

The question of whether to prescribe a course of antibiotics to a pregnant woman is a dilemma faced by obstetrics-gynecology (ob-gyn) care providers on a daily basis. In appropriate circumstances-such as the treatment of asymptomatic bacteriuria to prevent ascending infection and pyelonephritis-related adverse pregnancy outcomes-antibiotic therapy can be both effective and life saving. As with the administration of other medications, the potential benefits need to be weighed against the risk to the fetus. Some antibiotics are known to be teratogenic and should be avoided entirely during pregnancy. These include streptomycin and kanamycin (which may cause hearing loss) and tetracycline (which can lead to weakening, hypoplasia, and discoloration of long bones and teeth). How about other antibiotics? Are they safe? Can they be given with impunity?

A decade ago, a number of well-designed clinical trials¹^,² and systematic reviews³ concluded that broad-spectrum antibiotics can prolong the latency period (interval to delivery) and improve short-term perinatal outcome in pregnancies complicated by preterm premature rupture of membranes (pPROM) prior to 34 weeks of gestation, but not in women with preterm labor and intact membranes. Seven-year follow-up of the fetuses exposed to these antibiotics was recently published.⁴^,⁵ Reassuringly, broad-spectrum antibiotics given to fetuses in the setting of pPROM were not associated with any long-term disadvantage, although it is concerning to note that the short-term benefits in perinatal outcome described in the original report¹ did not appear to persist to age 7.⁴ Even more concerning, however, was the observation that fetuses exposed to broad-spectrum antibiotics in the setting of intact membranes were at significantly higher risk of cerebral palsy at age 7 (erythromycin, odds ratio [OR] 1.93; 95% confidence interval [CI], 1.21–3.09; co-amoxiclav, OR 1.69; 95% CI, 1.07–2.67).⁵ The risk was even higher when both antibiotics were given together (4.55% incidence of cerebral palsy compared with 1.97% for co-amoxiclav alone, 2.29% for erythromycin alone, and 1.63% for placebo).⁵ Exposure to co-amoxiclav was also associated with an increased risk of necrotizing enterocolitis.⁵

The mechanism of injury is not clear. The most likely explanation is an antibiotic-mediated suppression of infection and preterm birth, thereby causing the fetus to remain in a hostile proinflammatory intrauterine environment for a longer period of time. However, a direct injurious effect of the antibiotic itself cannot be excluded. Indeed, 1 reason why a significant association between antibiotics and cerebral palsy was observed with intact membranes but not in the setting of pPROM may have to do with the dose and/or duration of antibiotic exposure. Because the vast majority of women in the preterm labor and intact membrane study did not deliver within 48 hours (89.9%) or 7 days (84.6%) of enrollment, their fetuses were more likely to be exposed to the full 10-day course of antibiotic therapy.² In contrast, 30% to 40% of women in the pPROM study delivered within 48 hours and 55% to 60% within 7 days. As such, these fetuses were exposed to antibiotics for a far shorter period of time.¹ An additional adverse effect of the increased use of broad-spectrum antibiotics in the setting of pPROM is an increase in antibiotic resistance, especially erythromycin-resistant Group B β-hemolytic streptococcus (GBS).

The debate about the efficacy and safety of antibiotics in pregnancy must be seen in a larger context. It highlights the philosophical difference between 2 distinct groups of obgyn care providers: those who believe that everything possible should be offered in a given clinical setting in the hope that something will help (also known as the we don't have all the information we need or the might as well give it, it won't do any harm group) and those who hold out against popular opinion until there is consistent and compelling scientific evidence that an individual course of action is beneficial and has a favorable risk-to-benefit ratio (the so-called therapeutic nihilists). As protagonists of the latter camp, we offer the following suggestions to ob-gyn care providers faced with the dilemma of whether to prescribe a medication to a pregnant woman:

Use medications only if absolutely indicated. For antibiotics, this includes treatment of confirmed infection (urinary tract infection, pyelonephritis, appendicitis, cholecystitis, chorioamnionitis), prevention of ascending infection (asymptomatic bacteriuria), and prevention of early-onset neonatal GBS sepsis.
If possible, avoid initiating therapy during the first trimester. This is the period of fetal structural development and therefore the highest risk for iatrogenic teratogenicity.
Select a safe medication, which often means an older drug with a proven track record in pregnancy. Certain antibiotics (streptomycin, kanamycin, tetracycline) are best avoided entirely in pregnancy because of their teratogenicity.
Wherever possible, single-agent therapy is preferred over polypharmacy. Moreover, narrow-spectrum antibiotics are preferred over those with a broad spectrum for the treatment of established infection and intrapartum GBS chemoprophylaxis. The exception is the use of empiric broad-spectrum antibiotics to prolong latency in the setting of pPROM remote from term (discussed above).
Use the lowest effective dose.
Discourage the use of over-the-counter drugs, which may interfere with the efficacy and/or metabolism of prescription medications.

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References

1. Kenyon SL, Taylor DJ, Tarnow-Mordi W ORACLE Collaborative Group, authors. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group. Lancet. 2001;357:979–988. [PubMed]

2. Kenyon SL, Taylor DJ, Tarnow-Mordi W ORACLE Collaborative Group, authors. Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group. Lancet. 2001;357:989–994. [PubMed]

3. Kenyon S, Boulvain M. Antibiotics for preterm premature rupture of membranes. Cochrane Database Syst Rev. 2000;2 CD001058. [PubMed]

4. Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial. Lancet. 2008;372:1310–1318. [PubMed]

5. Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet. 2008;372:1319–1327. [PubMed]

Articles from Reviews in Obstetrics and Gynecology are provided here courtesy of MedReviews, LLC

Medicine by Alexandros G. Sfakianakis

Alexandros G .Sfakianakis,ENT,Anapafeos 5 Agios Nikolaos Crete 72100 Greece,00302841026182

Παρασκευή 26 Μαΐου 2017

Safe Antibiotics During Pregnancy  : Amoxicillin Ampicillin Clindamycin Erythromycin Penicillin Gentamicin Ampicillin-Sulbactam Cefoxitin Cefotetan Cefazolin

Medicine and Pregnancy