Accutane (its generic name is isotretinoin) is a drug derived from vitamin A, and is taken orally. It essentially stops the oil production in your sebaceous glands (the oil-producing structures of the skin) and literally shrinks these glands to the size of a baby's. This prevents sebum (oil) from clogging the hair follicle, mixing with dead skin cells, rupturing the follicle wall, and creating pimples or cysts. Normal oil production resumes when treatment is completed and the sebaceous glands slowly begin to grow larger again, but never (or at least rarely) as large as they were before treatment.

"Because of its relatively rapid onset of action and its high efficacy with reducing more than 90% of the most severe inflammatory lesions, Accutane has a role as an effective treatment in patients with severe acne that is recalcitrant to other therapies" (Source: Journal of the American Academy of Dermatology, November 2001, Supplemental, pages 188-194).

In a large percentage of patients who complete a four- to six-month treatment with Accutane, acne is no longer considered to be clinically significant. In other words, for all intents and purposes, their acne is cured! As the Food and Drug Administration stated, "Considered the biggest breakthrough in acne drug treatment over the last 20 years, Accutane is the only drug that has the potential to clear severe acne permanently after one course of treatment" (Source: FDA Consumer magazine, March-April 2001, http://www.fda.gov). Does this mean if you take it you'll never break out again? You may once in a while, but an occasional pimple here and there is hardly anyone's definition of acne. Especially anyone who, on a daily basis, had numerous breakouts, lots of blackheads, and oily skin.

The remaining percentage of patients who take Accutane do experience recurrences. For this group, when the breakouts return, typically three to six months after treatment, they are often milder and easier to treat, and can on occasion be cured with a second or third treatment of Accutane. Of course, there is a percentage that receives no benefit from taking Accutane, no matter how many treatments they take.

By the way, dosage and duration depend on the severity of the patient's acne, but treatments generally last 16 weeks. If a second treatment is necessary, an 8-week rest period is required between treatments. Interestingly, acne continues to improve even after the course of treatment is completed, although doctors do not know exactly why.

"[Accutane] is the treatment of choice for severe nodulocystic acne. It represents the sole agent that effectively addresses all of the pathophysiological factors in the production of acne" (Source: Seminars in Cutaneous Medical Surgery, September 2001, pages 162-165).

So what's the catch with this "miracle" drug and why don't doctors prescribe it to everyone? Accutane is controversial for many reasons, but principally because of its most insidious side effect: It has been proven to cause severe birth defects in nearly 90% of the babies born to women who were pregnant while taking it. Before physicians knew about this alarming hazard, when it was first prescribed in France back in the 1970s before enough research had been conducted to establish its safety, more than 800 babies out of 1,000 births were born seriously deformed. The only way to avoid this risk is to abstain from sex during treatment or, according to the information provided with every prescription, to use a minimum of two forms of birth control. If you are taking a birth-control pill, you still need to use a condom or diaphragm. You will need to discuss with your physician how long to continue using the extra birth-control precautions after you are done taking Accutane.

If you aren't pregnant, are there still risks? Absolutely. Commonly reported, although temporary, side effects of Accutane include dry skin and lips, mild nosebleeds, hair loss, aches and pains, itching, rash, fragile skin, increased sensitivity to the sun, headaches (mild to severe), and peeling palms and hands.

A study in the Journal of Cutaneous Medical Surgery (April 2000, pages 66-70) followed 124 people through their course of treatment with Accutane. "The majority of patients experienced persistent dryness of lips. Dry eyes affected 40% of patients; this continued throughout treatment in 25%. Contact lens wearers were more likely to develop conjunctivitis. Lower back pain was reported early in about 30% of patients and fewer than 10% of patients would develop it later in the course of treatment. Joint pain was noted in 16.5% of patients at the first visit and there was little change with ongoing treatment. Hair loss was experienced in a small percentage but was rarely noted on more than one occasion. Headaches occurred in less than 10% and were occasionally severe, but most often intermittent and recorded at a single visit. Depression occurred in 4% of patients and tended to persist throughout the treatment. All these patients completed the full course of treatment." The study concluded "patients treated with [Accutane] experienced a predictable series of side effects. Some occurred fleetingly, but several persisted for the duration of treatment."

More serious, although much less common, side effects include severe headaches, nausea, vomiting, blurred vision, changes in mood, depression, severe stomach pain, diarrhea, decreased night vision, bowel problems, persistent dryness of eyes, calcium deposits in tendons (the significance of this is unknown), an increase in cholesterol levels, and yellowing of the skin.

Understandably, many people, doctors included, are scared off by these side effects, above and beyond the risk to pregnant women. That's why dermatologists recommend Accutane only to patients with chronic acne (large, recurring cysts or blemishes that can permanently distort the shape and appearance of the skin), or sometimes to people with less-severe acne that has not responded successfully to other forms of treatment. Many doctors won't prescribe Accutane at all.

Although the high risk of birth defects and the other side effects should be taken seriously, it seems a shame that Accutane has been kept away from many acne patients. It is the most effective, short-term drug for acne available today. All other acne treatments require ongoing, tenacious adherence to the program and they don't offer a cure. The public is largely misinformed about Accutane's potential dangers as well as its potential benefit. Many doctors believe that if it weren't for the proven risk of birth defects, Accutane would be prescribed almost as frequently as antibiotics. Not surprisingly, it is prescribed much more frequently to men.

Paula Begoun