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Isotretinoin Pregnancy and Breastfeeding Warnings

Isotretinoin is also known as: Absorica, Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane

Medically reviewed on June 11, 2018

Isotretinoin Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: X

Comments:
-Female patients of reproductive potential should be tested for pregnancy before receiving a prescription for this drug.
-Any suspected fetal exposure during or 1 month after isotretinoin therapy must be reported at once to the FDA via the MedWatch number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the Internet (www.ipledgeprogram.com), and patients should be referred to a healthcare provider specialized or experienced in teratology.
-Effective contraception (at least 2 reliable forms) is required during therapy and for 1 month after the last dose; local protocol should be consulted regarding contraception timing.

Severe birth defects have occurred after exposure to this drug in any dose and over any duration, even for short periods of time. There are no accurate means to determine whether an exposed fetus is affected.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Isotretinoin Breastfeeding Warnings

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-This drug is highly lipophilic, and may be expressed into breastmilk.
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Accutane (isotretinoin)." Roche Laboratories, Nutley, NJ.

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. "Product Information. Accutane (isotretinoin)." Roche Laboratories, Nutley, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. 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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