Is tigecycline safe during pregnancy?
The safety of tigecycline, a broad-spectrum antibiotic, during pregnancy has been a concern due to its potential to cross the placenta and affect fetal development [1]. Tigecycline belongs to the glycylcycline class of antibiotics, which are structurally related to the tetracyclines.
Contraindications and warnings
The manufacturer of tigecycline, Pfizer, recommends avoiding its use in pregnant women, especially during the first and third trimesters, due to the potential risk of inhibiting bone growth and causing tooth discoloration in the fetus [2]. The FDA pregnancy category for tigecycline is C, indicating that animal studies have shown adverse effects on the fetus, but human studies are lacking, or studies in humans have not demonstrated a risk [3].
Animal studies and risk assessments
Studies in rats and rabbits have shown that tigecycline can cross the placenta and accumulate in the fetus, leading to developmental toxicity, including skeletal abnormalities and fetal death [4]. A study on pregnant rats also found that tigecycline exposure during organogenesis led to increased rates of skeletal anomalies, including bone deformities and craniofacial defects [5].
Clinical considerations and monitoring
If tigecycline is prescribed to a pregnant woman, healthcare providers should carefully weigh the potential benefits against the potential risks. Patients should be informed of the potential risks and monitored for any signs of fetal toxicity, such as changes in fetal movement, swelling, or preterm labor. Regular ultrasound examinations can help detect any potential fetal abnormalities [6].
Alternatives and precautions
In cases where tigecycline is contraindicated, alternative antibiotics, such as ampicillin-sulbactam, gentamicin, or fluoroquinolones, may be considered for the treatment of infections during pregnancy [7]. However, the choice of alternative antibiotics should be made on a case-by-case basis, taking into account the severity of the infection and the potential risks associated with each option.
[1]
https://www.drugpatentwatch.com/drug/tigecycline-2020/
[2]
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s006lbl.pdf
[3]
https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/FeatureArticlesUCM279129
[4]
https://www.ncbi.nlm.nih.gov/pubmed/15351445
[5]
https://www.ncbi.nlm.nih.gov/pubmed/18311158
[6]
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4341516/
[7]
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4211919/
https://www.drugpatentwatch.com/