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Tigecycline Pregnancy and Breastfeeding Warnings

Tigecycline is also known as: Tygacil

Medically reviewed on July 14, 2016

Tigecycline Pregnancy Warnings

Animal studies have revealed evidence of fetal harm. Fetal weight reductions and increased incidence of skeletal anomalies (delayed bone ossification) were observed at exposures 5 times and equal to the daily human dose based on AUC in rats and rabbits, respectively; increased incidence of fetal loss was found at maternotoxic doses in rabbits (exposure equal to human dose). Tigecycline crossed the placenta and was found in fetal tissues (including bony structures). There are no controlled data in human pregnancy.

Use of this drug during tooth development (second half of pregnancy) may cause permanent yellow-gray-brown discoloration of the teeth.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: D
-According to at least 1 manufacturer: Not assigned.

Risk summary: This drug may cause fetal harm.

Comments:
-This drug should not be used during tooth development unless other drugs contraindicated or unlikely to be effective.
-Women who become pregnant during therapy should be advised of the potential hazard to the fetus.

See references

Tigecycline Breastfeeding Warnings

Caution is recommended.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

References for pregnancy information

  1. Slover CM, Rodvold KA, Danziger LH "Tigecycline: a novel broad-spectrum antimicrobial." Ann Pharmacother 41 (2007): 965-72
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Tygacil (tigecycline)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Tygacil (tigecycline)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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