
Clarithromycin is an antibiotic used to treat common infections such as respiratory tract infections, skin infections, and helicobacter pylori infections. While it is considered relatively safe for use during pregnancy, there are some potential risks associated with its use. Animal studies have shown that clarithromycin can induce fetal loss in rabbits and monkeys when used in very low and high dosages, respectively. Additionally, a study found a doubling in the frequency of miscarriages among women using clarithromycin in early pregnancy. However, most studies of women who took macrolides provide no evidence of a link with birth defects in the baby, and the majority of studies also provide no evidence of a link with miscarriage. Overall, clarithromycin is generally considered safe during pregnancy, but it is important to consult with a healthcare provider to weigh the benefits and risks.
Characteristics | Values |
---|---|
Safety during pregnancy | Not recommended for use during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. |
Pregnancy category | AU TGA: B3, US FDA: C |
Miscarriage risk | Increased hazard of miscarriage but no increased prevalence of having offspring with malformations. |
Congenital malformations | No evidence of a link with birth defects in the baby. |
Antibiotic type | Macrolide |
Alternative antibiotics | Erythromycin, penicillin, amoxicillin |
What You'll Learn
Clarithromycin and miscarriage
Clarithromycin is an antibiotic used to treat common infections, including respiratory tract infections, skin infections, and helicobacter pylori infections. It is not recommended for use during pregnancy as it has been associated with fetal loss in animal studies and a doubling of miscarriages in pregnant women.
A nationwide cohort study in Denmark found that women who redeemed a prescription for clarithromycin in the first trimester had a 1.56 times higher risk of miscarriage compared to those who did not take the drug. This translates to a 10% miscarriage rate among women taking clarithromycin, compared to an 8.3% rate in the unexposed group.
The study also investigated whether there was an association between clarithromycin use and major congenital malformations. Among the 401 women exposed to clarithromycin in the first trimester, nine children (3.6%) were diagnosed with a major malformation, compared to 24,808 (3.5%) among children born to unexposed mothers. The study concluded that there was no significant difference in the number of major malformations between the two groups.
Animal studies have shown that clarithromycin can induce fetal loss in rabbits and monkeys when used in very low and high dosages, respectively. However, there is limited knowledge regarding the risk of congenital malformations in women exposed to clarithromycin during pregnancy.
Overall, while clarithromycin has been linked to an increased risk of miscarriage, there is no clear evidence of an association with major congenital malformations. However, further research is needed to fully understand the effects of clarithromycin on pregnancy outcomes.
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Clarithromycin and malformations
Clarithromycin is an antibiotic used to treat common infections, including respiratory tract infections, skin infections, and helicobacter pylori infections. It is a macrolide antibiotic, which is a group of antibiotics used to treat a wide range of infections.
There have been concerns about the safety of using clarithromycin during pregnancy due to its association with fetal loss in animal studies and an increased risk of miscarriage in pregnant women. To investigate this further, a nationwide cohort study was conducted in Denmark, including all women with a known conception between 1997 and 2007. The study aimed to determine the risk of miscarriages and major malformations among users of clarithromycin compared to non-users.
The results of the study showed that out of 931,504 pregnancies, 401 women redeemed a prescription for clarithromycin in the first trimester. Of these, 40 (10.0%) experienced a miscarriage, and among the live births, nine (3.6%) had offspring with malformations. The hazard ratio (HR) of miscarriage after exposure to clarithromycin was 1.56 (95% CI: 1.14-2.13). However, there was no increased prevalence of having offspring with malformations after exposure to clarithromycin (OR = 1.03, 95% CI: 0.52-2.00).
The study concluded that there was an increased hazard of miscarriage associated with clarithromycin use in early pregnancy but no increased prevalence of having offspring with malformations. These findings align with previous studies in animals and humans. However, the study also highlights the need for further research to explore the possible effects of treatment indication on the associations found.
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Clarithromycin alternatives during pregnancy
While clarithromycin can be taken during pregnancy, it is not recommended unless there are no alternatives and the benefit outweighs the risk to the foetus. This is because animal studies have shown that clarithromycin can induce fetal loss in rabbits and monkeys when used in very low and high dosages, respectively. Additionally, a study on pregnant women showed a doubling of the number of miscarriages in those exposed to clarithromycin in early pregnancy compared to a control group.
If you are pregnant and have been prescribed clarithromycin, it is important to discuss alternatives with your doctor. Erythromycin is the most commonly prescribed macrolide during pregnancy and is considered safe. Other types of antibiotics can also be used during pregnancy, depending on the type of infection being treated and your medical history.
It is important to remember that treating infections during pregnancy is crucial for the health of both mother and baby. Always consult your doctor or midwife if you have any concerns about the medicines you are offered during pregnancy.
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Clarithromycin and breastfeeding
Clarithromycin can be taken while breastfeeding. It passes into breast milk in very small amounts and is unlikely to cause side effects in babies. However, there have been some cases of mild upset stomach and drowsiness in babies whose mothers were taking the medication.
If your baby is healthy, your doctor will likely approve you taking clarithromycin while breastfeeding. However, if your baby is not feeding as well as usual, has a rash, is unusually sleepy, has an upset stomach or oral thrush, or if you have any other concerns, talk to your doctor, pharmacist, or midwife.
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Clarithromycin and animal studies
Animal studies have shown that clarithromycin can induce fetal loss in rabbits and monkeys when used in very low dosages and high dosages, respectively. In rabbits, an intravenous dose 17 times lower than the maximum proposed human dose was found to increase fetal loss. In monkeys, clarithromycin plasma levels three times the human serum level resulted in embryonic loss.
Animal reproduction studies have also shown that clarithromycin has adverse effects on pregnancy outcomes and/or embryofetal development, including a low incidence of cardiovascular anomalies, variable incidence of cleft palate, delayed fetal growth, and spontaneous abortions. These adverse effects were observed at doses that produced plasma levels 2 to 17 times the human serum levels achieved using the maximum recommended human dose.
The US FDA has classified clarithromycin as a Pregnancy Category C drug, indicating that animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans. However, the potential benefits of the drug may still warrant its use in pregnant women despite the potential risks.
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Frequently asked questions
Clarithromycin is a category C drug, which means it has been shown to have negative effects in animal studies, but there is limited data on its effects in humans. It is not recommended for use during pregnancy unless there are no alternatives and the benefits outweigh the risks.
Animal studies have shown evidence of adverse effects on pregnancy outcomes and/or embryofetal development, including cardiovascular anomalies, cleft palate, delayed fetal growth, and spontaneous abortions. However, there is limited data on the effects of clarithromycin in humans, and further research is needed.
Yes, other types of antibiotics can be used during pregnancy. Erythromycin is the most commonly prescribed macrolide during pregnancy and is generally considered safe. Penicillin is another alternative that is often used unless there is a confirmed allergy.