From the FDA Drug Label
Pregnancy: Cefixime should be used during pregnancy only if clearly needed. The use of Cefixime in pregnancy is allowed, but only if clearly needed, according to the FDA drug label 1.
- The label does not specify any particular trimester, including the fifth month.
- However, it is essential to weigh the benefits and risks before administering Cefixime to a pregnant woman.
- A conservative clinical decision would be to use Cefixime in a 5-month pregnant woman only if clearly needed, and under the guidance of a healthcare professional.
From the Research
Cefixime can be used during pregnancy, including at 5 months, when the potential benefits outweigh the risks, as it is classified as FDA pregnancy category B, meaning animal studies have not shown harm to the fetus, though adequate human studies are limited. The typical adult dose is 400 mg daily, either as a single dose or divided into two 200 mg doses, with treatment duration depending on the infection being treated (usually 7-14 days) 2. While cefixime is generally considered safe in pregnancy, it should only be prescribed by a healthcare provider who can evaluate your specific condition and medical history.
Key Considerations
- The antibiotic works by inhibiting bacterial cell wall synthesis, and is effective against many common infections including urinary tract infections and certain respiratory infections.
- Common side effects may include diarrhea, abdominal pain, and nausea.
- Always complete the full course of antibiotics as prescribed, even if symptoms improve before finishing the medication.
- It is essential to note that the provided evidence primarily discusses the risks associated with macrolide antibiotics during pregnancy, rather than cefixime specifically 3, 4, 5.
- However, given the lack of direct evidence on cefixime in the provided studies, the decision to use cefixime during pregnancy should be based on the general principles of antibiotic use in pregnancy, weighing the potential benefits against the risks.
Evidence Review
- A study published in 2020 found an association between macrolide antibiotics prescribing during pregnancy and major malformations, specifically cardiovascular malformations 5.
- Another study from 2019 found that macrolide use during pregnancy was associated with an increased risk of miscarriage, cerebral palsy, and epilepsy compared to alternative antibiotics 4.
- However, these studies do not directly address the safety of cefixime during pregnancy, and therefore, the decision to use cefixime should be made on a case-by-case basis, considering the potential benefits and risks.
Clinical Decision
- In the absence of direct evidence on cefixime, the clinical decision to use cefixime during pregnancy should prioritize the potential benefits and risks, and alternative antibiotics should be considered if possible.
- The healthcare provider should evaluate the specific condition and medical history of the patient to make an informed decision.
- It is crucial to monitor the patient for any potential side effects and adjust the treatment plan as necessary.