Accutane and Pregnancy
From Pharmacy Drug Guide
The FDA approved Accutane in 1982 to treat severe acne that does not improve with other therapies, including antibiotics. Since there have been adverse effects reported with Accutane and pregnancy, women are strongly warned against taking Accutane while pregnant or breastfeeding. Accutane side effects can include birth defects, miscarriage, fetal death and premature birth. Women who plan to become pregnant must stop taking Accutane at least a month before conceiving and not begin taking Accutane again until a month after giving birth. Breastfeeding mothers also must not take Accutane.[1] [2]
Accutane was developed and manufactured by Roche Pharmaceuticals and it has been available in generic form since 2002. The generic form of the medicine isotretinoin is available in the United States and elsewhere, manufactured and distributed by Barr Laboratories, Genpharm/Mylan Pharmaceuticals, and Ranbaxy Laboratories.[3]
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| Brand name for | Isotretinoin |
|---|---|
| Used for | Treating severe nodular acne |
| Pregnancy Risk Factor | X |
| Label instructions | Take Accutane exactly as prescribed; do not chew or suck on the tablet. Swallow it whole with a full glass of water. |
| Warnings | Prescribers, pharmacies and patients must be registered with the iPLEDGE program to prevent pregnancy while taking isotretinoin[4] |
| Disclaimer | The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician. |
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Accutane and Pregnancy Category X
Specialists are so concerned about the effects of Accutane or isotretinoin in pregnant women that everyone who prescribes, supplies, or takes the drug must sign the iPLEDGE, a commitment to preventing pregnancy while the medication is used.[4] Even men and women who are not of childbearing age may be asked to sign the iPLEDGE. Because the effects of Accutane or the generic form, isotretinoin, are so serious, women must agree to use two forms of birth control before, during, and immediately after this therapy. Even sexually abstinent women must use an additional form of birth control during Accutane treatment.[5] The risk of fetal malformations is not dependent on dose or on the length of time Accutane is taken; a single pill can cause serious effects on a developing fetus.[2]
About Drug Side Effects
Accutane and Breastfeeding
Women taking Accutane must not breastfeed their infants for at least a month after stopping the drug.[5] Researchers don't know for sure if Accutane passes from the mother to the infant by breast milk, but it seems likely. Since Accutane is used to treat a non-life-threatening condition, acne, mothers are advised to postpone the therapy until after the baby is weaned.[2]
Also See: Accutane Lawsuit, Accutane Side Effects, Birth Control Pills, Birth Control Recall, Drugs and Pregnancy
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References
- ↑ http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s061MedG
- ↑ 2.0 2.1 2.2 https://www.ipledgeprogram.com/Documents/Roche%20Accutane%20Package%20InsertI.pdf
- ↑ http://www.rocheusa.com/portal/synergy/static/file/synergy/alfproxy/download/1414-cd2ddc12b4d211deadd62f6357bc6b3c/
- ↑ 4.0 4.1 https://www.ipledgeprogram.com/default.aspx
- ↑ 5.0 5.1 http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000532/
