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Telithromycin Pregnancy and Breastfeeding Warnings

Telithromycin is also known as: Ketek, Ketek Pak

Telithromycin Pregnancy Warnings

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

US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity, but delayed fetal maturation was observed at maternally toxic doses. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Telithromycin Breastfeeding Warnings

LactMed: Use of this drug is not a reason to discontinue breastfeeding if it is required by the mother; alternate therapy may be preferred, especially if the nursing infant is premature or younger than 1 month.
-UK: Use is not recommended.
-US: Caution is recommended.

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

Comments:
-The effects in the nursing infant are unknown; according to some experts, the nursing infant should be monitored for possible effects on the gastrointestinal tract (e.g., diarrhea, vomiting, candidiasis [thrush, diaper rash]).

See references

References for pregnancy information

  1. "Product Information. Ketek (telithromycin)." Aventis Pharmaceuticals, Bridgewater, NJ.
  2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  3. "Product Information. Ketek (telithromycin)." Aventis Pharmaceuticals, Bridgewater, NJ.

Further information

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

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