Isotretinoin For Acne
Isotretinoin is an oral medication that is prescribed to patients when all other acne treatments, including oral antibiotics, topical medications and oral contraceptives, have failed. The American Academy of Dermatology (AAD) points out that isotretinoin is the most effective treatment for severe acne. Originally marketed under the trade name, Accutane, this medication has had a controversial history with the U.S. Food & Drug Administration (FDA) since it was approved for use in the early 1980s.
The AAD states that isotretinoin is an aggressive medication typically prescribed for severe cases of acne--lesions that present as deep cysts or nodules accompanied by inflammation that have the potential to severely scar the skin. Oral isotretinoin, which is derived from vitamin A, fights all of the factors that lead to acne: excess sebum, clogged pores, bacteria and inflammation. The medication is taken daily for 16 to 20 weeks. Patients who take isotretinoin may notice full resolution of acne that can last for up to several years. For many, however, only one course of isotretinoin is enough to resolve severe acne.
The FDA first cleared isotretinoin, which was patented under the brand name Accutane by Roche Holding AG, in 1982 to treat acne that was unresponsive to other types of more conventional therapies. Since that time, isotretinoin has posed one of the FDA's most serious challenges, as several side-effects have since been discovered that warranted further research and stringent regulation of the drug. This resulted in additional warning labels and patient education programs. In the early 2000s, the FDA formed a risk management program for ongoing study of isotretinoin use. This resulted is iPLEDGE, a mandatory patient program designed to reduce fetal exposure to isotretinoin. Additionally, in 2007, the FDA applied a warning label to isotretinoin indicating that use of the drug could cause severe depression and suicidal thoughts in some patients.
Drugs.com notes that isotretinoin is usually taken twice daily, along with a meal and a full glass of water or milk to avoid possible stomach upset. It's important not to crush the capsules or let them dissolve in your mouth. Alcohol should be avoided while taking isotretinoin. Drugs.com and the AAD state that during the early stages of treatment, acne may become worse before it gets better. After treatment ceases, patients typically go through a 2-month period to assess the effectiveness of isotretinoin. If acne doesn't respond, a dermatologist might recommend another course of therapy or advise a longer rest period, especially for younger patients who are still growing.
Side Effects and Dangers
Although isotretinoin can ultimately resolve the most stubborn case of severe acne, it comes with a legion of potential side effects, says the Mayo Clinic. Milder side effects patients can expect include extremely dry skin, eyes and oral and nasal mucosa; temporarily thinning hair (during treatment); nosebleeds; headaches; and joint pain. More serious side effects can include blurry or decreased night vision, bloody stool/diarrhea, nausea and vomiting and changes in mood and behavior. Isotretinoin contraindicates many medications and may not be appropriate for those with certain medical disorders, such as diabetes. The AAD states, however, that one of the most profound dangers of isotretinoin use is that it causes birth defects in developing fetuses.
Isotretinoin and Women
Isotretinoin cannot be taken by pregnant patients or those who intend to get pregnant. Therefore, the FDA requires isotretinoin to be distributed to female patients of child-bearing age with extreme caution. Women must take use two forms of birth control while taking the drug, as well as undergo pregnancy testing before, during and after treatment. Females must also sign up for the FDA's iPLEDGE monitoring program in order to receive isotretinoin.
Bloomberg.com reported in June 2009 that Roche intended to pull Accutane from the shelves. The company cited financial losses due to competition from Accutane's less-expensive, generic competitors, as well as the high costs related to personal injury lawsuits filed by patients who took Accutane before the full extent of its potential side-effects had been determined. Isotretinoin continues to be sold under the brand names Amnesteem, Claravis and Sotret.
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