Last Updated on July 31st, 2019
Accutane is sometimes almost a miracle drug for cystic acne, but this potent drug can cause significant side effects1. Accutane is usually a drug of last resort for acne, used only when all other treatments fail. Many people who use Accutane, however, fail to realize the potential for serious complications in treatment.
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Every case of common acne begins with an event known as retention hyperkeratosis. For reasons that researchers do not yet understand, the linings of a pore in the skin start to produce cells at an unusually fast rate. They begin to tighten the pore so that sebum cannot drain.
After a few days to a few weeks, these additional cells in the lining of the pore are shed so that younger cells beneath them can come to the surface. They form a clump in the pore that blocks the flow of oil and traps acne bacteria. The immune system attacks the bacteria4 with inflammation and makes the pore even tighter so that a whitehead or blackhead forms, or the lining of the pore begins to break down, causing a pimple.
Sometimes there is also hyperkeratosis of the skin surrounding the pore. Skin can grow over the pore, trapping sebum and acne bacteria inside. The immune system continues attacking the bacteria, destroying more and more healthy skin tissue until a cyst or a nodule forms under the skin.
Accutane reverses this process5 by making hyperkeratosis less “hyper.” It reduces the production of an enzyme called telomerase, which repairs cellular DNA. Without the action of telomerase, cells die more quickly and can be flushed out of pores and off the skin. It also activates a gene that codes proteins to make neutrophil gelatinase-associated lipocalin, an enzyme that breaks down the “glue” that holds clumps of dead skin cells together inside pores and on the skin. Pores begin to open from the inside out, spilling their contents on the skin. The chemical changes induced by Accutane are temporary, but clearing of the skin may be permanent.
Accutane is found under a variety of trade names. In the United States, the drug formerly known as Accutane has been marketed by Hoffman-La Roche as Roaccutane since July of 2009. In other countries, the same drug is sold as Acnotin, Amnesteem, Claravis, Clarus, Decutan, Isohexal, Isosupra, Isotane, Isotret, Isotroin, Izoteik, Oratane, Ruatine, and Sortret. There also is a lotion made with the same drug marketed as Isotrex and a combination of Accutane and erythromycin sold as Isotrexin.
Accutane is a very effective treatment for cystic acne6 that can and often does cause serious side effects. Because the drug breaks down the “glue” that holds skin cells together, it often causes itchy peeling of the skin. Oral Accutane causes dryness of the skin and mucous membranes. Dry skin can cause dandruff and rashes. Dry mucous membranes can lead to nose bleeds and, in women, vaginal yeast infections.
The US Food and Drug Administration7 warns that the drug may cause the premature closing of the ends of long bones, stopping further growth. The long bones in the upper body may continue growing until age 18, and the long bones in the lower body may still be growing as late as age 23. Use of Accutane may stop further growth.
Users of Accutane who are prone to rosacea may have breakouts (even if they have never had rosacea before). There can be hair loss, eye irritation, permanent thinning of the skin, easy bruising, elevated liver enzymes, back pain, and high blood sugar levels. In rare cases, use of Accutane can result in loss of night vision, depression, formation of calcified cysts in muscle tissue, cataracts, increased blood pressure in the brain (cranial hypertension), and erectile dysfunction in men. Some of these side effects may become permanent. There also seems to be an increased risk of suicide associated with the drug. But the most serious side effects of the drug do not occur in its users.
The risk of birth defects caused by the use of Accutane is real9. Birth defects caused by Accutane are most likely to affect the frontal lobes of the brain. A child who is exposed to Accutane through the mother’s bloodstream in the first trimester of pregnancy10 may be challenged with severe learning disabilities. There have been cases in which an anencephalic (brain-less) child was born to a woman using the drug, although most of the time the use of the drug in early pregnancy results in spontaneous or intentional abortion.
In the United States, a peculiar system called iPLEDGE has been developed to prevent the use of Accutane by women who could become pregnant. The iPLEDGE system is non-discriminatory11. Women who have passed menopause are required to be enrolled in the system if they are to be given Accutane. And just in case some man might get pregnant, males who are given prescriptions for Accutane are required to be registered with the system, too.
There is a 7-day window for anyone getting a first prescription for the drug. If a prescription is not picked up in those seven days, the physician must re-enroll them in the system. Patients are only allowed to get refills for Accutane as long as their physicians update iPLEDGE information every 30 days. Women are only allowed to use Accutane as long as they agree to use not just one but two different forms of contraception, and women’s prescriptions for Accutane begin on the second or third day of their menstrual periods, when there is no risk that they might be fertile.
There are also restrictions on the use of Accutane in Canada, Australia, Colombia, Mexico, and Brazil. About 200 babies worldwide were born with birth defects before Accutane was regulated. Roughly 1 in 10 pregnancies of women who were taking Accutane results in the birth of a baby with serious developmental challenges12.
As dreadful as the side effects of Accutane can be13, most of the the worst side effects of the drug are very rare14. However:
The remedy for all of these side effects is to avoid additional irritation and to moisturize. The corners of the mouth and the skin of the face should be treated with moisturizer and sunscreen daily. It also helps to avoid using lip balm or lip gloss that has flavors or fragrances and to avoid use of toothpaste and mouthwash that contain the ingredient sodium lauryl sulfate (SLS), since these can also irritate the corners of the mouth. People who wear contact lenses, in particular, may benefit from using liquid tears several times a day to keep the eyelids moist.
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