ISOTRETINOIN

    Isotretinoin is a prescription medication used to treat a severe form of acne that has not been helped by other treatments.  The drug usually clears the skin of affected individuals for prolonged periods.  Brands of isotretinoin include Accutane, Amnesteem, Claravis, and Sotret.  Isotretinoin is a member of a family of drugs called retinoids, which are related to vitamin A. When taken during pregnancy, isotretinoin and other retinoids can cause miscarriage or very serious birth defects. Safer acne treatments for women of childbearing age include topical or oral medications including erythromycin, clindamycin, or benzoyl peroxide, antibacterial agents that dry the skin.

 

   For more information concerning isotretinonin and the iPLEDGE program, please visit their site at:

 

https://www.ipledgeprogram.com/

 

    A mandatory risk management program called iPLEDGE was instated in 2005 by the FDA and isotretinoin manufacturers. This program aims to assure that no pregnant woman starts taking isotretinoin, and no woman taking isotretinoin becomes pregnant. Besides causing birth defects, isotretinoin can seriously alter mental health.[2]

 

Risks of using isotretinoin during pregnancy involve a high incidence of birth defects.  Taking even a small amount of the drug for a short period can cause:

    * Hydrocephaly (enlargement of the fluid-filled spaces in the brain)

    * Microcephaly (small head and brain)

    * Mental retardation

    * Ear and eye abnormalities

    * Cleft lip/palate and other facial abnormalities

    * Heart defects

    * heightened risk of miscarriage or premature birth

Isotretinoin can cause these birth defects in the early weeks after conception, even before a woman knows she is pregnant. Even babies without obvious malformations may have mental retardation or learning disabilities.

 

Things to avoid while using isotretinoin:

* Breastfeeding should be avoided for at least 1 month after stopping use.  It is not known whether it could harm the baby.

   * Women or men using isotretinoin should avoid giving blood while taking the drug and for one month afterward.  The drug might cause birth defects if a 

         pregnant women receives the blood.

   * Women should avoid using herbal preparations, such as St. John’s wort because it may cause birth control pills to work less effectively.[1]

 

 

OTHER RETINOIDS

    Topical retinoids also are used to treat acne.  These medications have not been proven safe for use during pregnancy. Small amounts of these drugs may be absorbed through the skin into the bloodstream, and should be avoided during pregnancy.  All oral retinoids pose a risk of birth defects and should be avoided during pregnancy.    

 

    Soriatane (acitretin) is a retinoid that is used to treat severe psoriasis, a chronic disfiguring skin disease. This can also cause serious birth defects, including craniofacial and heart defects, spina bifida and limb defects. This drug remains in the body for a prolonged period and should not be used by women planning to become pregnant within three years after stopping the drug. 

 

    Tegison (etretinate)stays in the body for an espcially prolonged period. Some doctors recommend that women avoid pregnancy indefinitely after taking Tegison.  Women who take Soriatane should not drink alcoholic beverages while taking the drug or for two months afterward. This combination causes the body to turn Soriatane into etretinate (the active ingredient in Tegison), which may remain in the body for many years after treatment ends.

 

    Other retinoids used to treat certain cancers of the blood also pose a risk of birth defects. These include Vesanoid (tretinoin), used to treat acute promyelocytic leukemia, and Targretin (bexarotene), used to treat a form of T-cell lymphoma.

 

    Vitamin A is necessary for normal fetal growth and development, but too much may cause birth defects. Women taking more than twice the FDA’s current Daily Value (DV) of vitamin A in the first two months of pregnancy had more than double the risk of having a baby with birth defects. While under 25,000 IU probably does not cause birth defects, but the lowest dose that can cause birth defects is unknown.[1]

 

 

                                                    - Preamture Birth

                                                    - Microcephaly

                                                    - Hydrocephaly

                                                    - Cleft lip and cleft palate

                                                    - Down's syndrome

 

 

REFERENCES:

    [1]    March of Dimes. (2005).  Quick Reference Fact Sheets: Accutaine and Other Retinoids.  Retrieved October 1, 2007, from    

                http://www.marchofdimes.com/professionals/14332_1168.asp

    [2]    U.S. Food & Drug Administration. (2005). FDA Announces Strengthened Risk Management Program to Enhance Safe Use of Isotretinoin (Accutane) for        

                Treating Severe Acne. Retrieved September 28, 2007, from http://www.fda.gov/bbs/topics/NEWS/2005/NEW01218.html

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