Accutane has been available through prescription as a treatment for severe acne since 1983. It is currently available in about 80 countries.
It is expensive. The drug costs from $500 to $600 for a standard first treatment of about 16 weeks. Most drug plans cover the drug - they will usually place some limits on coverage.
In 1995, 71.8 per cent of all Accutane prescriptions were issued by dermatologists. General practitioners issued 25.1 per cent of Accutane prescriptions. By last year, prescriptions issued by dermatologists accounted for 60 per cent of the total. General practitioners issued 35 per cent of all Accutane prescriptions. (Source: IMS Health, CompuScript 2000)
Accutane has now been linked with a long list of serious side effects which are frequent, varied and at times severe.
According to the manufacturer of Accutane, some patients, while taking the drug or soon after stopping, have become depressed or developed other serious mental problems. Signs of these problems include feelings of sadness, irritability, unusual tiredness, trouble concentrating and loss of appetite. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives and other people have ended their own lives.
Known side effects of Accutane:
* dryness of the skin, lips, mouth and lining of the nose
* facial or body rash, flaking of the skin, itching, peeling of the palms and soles
* increased sensitivity to the sun
* inflammation of the lips, mild nose bleed
* bleeding and inflammation of the gums
* aches and pains in the joints
* increased fatigue
* decreased night vision
People on Accutane are also warned to avoid excessive exposure to the sun and not to use vitamin preparations or health food supplements that contain vitamin A. Patients are also advised to avoid waxing for 5-6 months after taking Accutane - because of the risk of scarring.
Accutane rules tightened
More than 1,300 psychiatric side effects and as many as 66 suicides have been reported since Accutane arrived on the market. The numbers prompted the Food and Drug Administration to take another look at Accutane.
The FDA has changed its rules regarding the drug so that doctors must now get patients to sign a consent form. The form is produced by Accutane's maker, Roche Pharmaceuticals. It says the patient understands all the risks associated with Accutane, including depression and suicide. Pharmacists must also hand out a detailed warning brochure from the FDA, called a Medguide. Accutane is one of just three drugs in the United States that has ever been required to come with a Medguide.
A brochure put out by Accutane's maker, designed for patients, still makes no mention of the reports of depression or suicide, although it cautions those who feel depressed or suicidal to contact their doctor.