Isotretinoin (Accutane®)

Oral Retinoid
Compare To Other Treatments

Pregnancy

Isotretinoin MUST NEVER BE USED during pregnancy because it can cause serious harm to an unborn baby, including severe birth defects, miscarriages, or premature births. If you are pregnant or planning to become pregnant and are considering isotretinoin, tell your doctor right away.

Women who could become pregnant must follow strict rules before starting isotretinoin, including taking two negative pregnancy tests and enrolling in the iPLEDGE™ program to ensure safety.

If a woman becomes pregnant while taking isotretinoin, the medicine must be stopped immediately, and she should see a gynecologist to discuss the risks to the baby.

Isotretinoin should only be used if absolutely necessary, with careful planning to avoid pregnancy during treatment.

Breastfeeding

There is no data on the presence of isotretinoin in either animal or human milk, the effects on the breastfed infant, or the effects on milk production. However, because of the potential for serious adverse reactions in nursing infants from isotretinoin, breastfeeding is not recommended during treatment with isotretinoin, and for at least 8 days after the last dose of isotretinoin.

Females and Males of Reproductive Potential

  • Pregnancy Testing
    Isotretinoin should only be prescribed to patients who are confirmed not to be pregnant. Patients who can become pregnant must provide two negative urine or blood pregnancy tests before the first isotretinoin prescription. These tests must be conducted at least 19 days apart.
  • Contraception
    Patients who can become pregnant must use 2 forms of contraception simultaneously, at least 1 of which must be a primary form, for at least 1 month prior to initiation of isotretinoin therapy, during isotretinoin therapy, and for 1 month after discontinuing isotretinoin therapy. Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) are an inadequate method of contraception during isotretinoin therapy.
  • Infertility in Females
    Current data show that isotretinoin treatment can reduce female fertility after 6 months, but the values returned to normal 12 months after the end of treatment. Although the results suggest that possible degenerative effects of isotretinoin on ovaries may be reversible, the study has important limitations, including a small sample size, lack of a control group, and lack of generalizability.
  • Infertility in Males
    Available studies showed no significant effects of isotretinoin on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.
References
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  2. Uptodate.com. (2024). Isotretinoin. [online] Available at: https://www.uptodate.com/contents/oral-isotretinoin-therapy-for-acne-vulgaris [Accessed 14 Sept 2024].
  3. Epocrates.com. (2024). Isotretinoin. [online] Available at: https://online.epocrates.com/drugs/34510/isotretinoin/Monograph. [Accessed 14 Sept. 2024].
  4. DailyMed.nlm.nih.gov. (2024). Isotretinoin capsule, liquid filled [online] Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1edbb8-ac0e-4563-9c2a-94385ce055e3 [Accessed 14 Sept. 2024]
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