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Accutane)
Structure of Isotretinoin (13-cis-retinoic acid)
Isotretinoin is a very effective drug used for the treatment of acne. It is a retinoid, meaning it is derived from Vitamin A and is found naturally in the body, produced by the liver in small quantities. Isotretinoin is sold under many brand names, including Accutane and Roaccutane by Roche. It is also marketed as Accure, Oratane, and Isohexal by other companies.
History
Approved in 1982 by the FDA for use in the treatment of severe cystic acne that had not responded to other treatment. Isotretinoin was originally marketed as Accutane (or Roaccutane outside the USA) by Roche. Although originally indicated for severe cystic acne, today it is prescribed much more liberally.
Effects
Isotretinoin noticeably reduces the production of sebum and shrinks the sebaceous glands. It stabilises keratinization and prevents comedones from forming. The exact mechanism of action is unknown, however it is known that it alters DNA transcription.
Indications for treatment
Isotretinoin is indicated for treatment for a number of dermatological conditions, most commonly acne. It is generally not used as a first-line treatment due to the potential side effects. Antibiotics (such as the tetracyclines) are usually prescribed before isotretinoin.
Severe forms of acne (conglobata, fulminans and nodulocystic) as well as acne that scars can be successfully treated with isotretinoin.
Acne that has not responded to other treatment will usually respond to isotretinoin. Dysmorphobic patients may also be prescribed isotretinoin.
Dosage
The dose of isotretinoin a patient receives is dependant on their weight and the severity of the condition. Generally it is prescribed from between .5mg/kg/day to 2mg/kg/day, for example a 70kg (155 pounds) person would take from between 35mg to 140mg per day dependant on the severity of their condition.
It should also be noted that some studies have associated remission of the condition with the total dose taken. It is generally advisable to take a dose of greater than 125mg/kg over the entire treatment period to see maximum benefit.
Side Effects
Teratogenicity
Isotretinoin is a teratogen, it is highly likely that if taken during pregnancy that it will cause birth defects. These defects include severe brain and heart defects and mental retardations.
In the U.S. more than 2,000 women have become pregnant while taking the drug between 1982 and 2003, with most pregnancies ending in abortion. About 160 babies with birth defects were born. Doctors normally require two separate methods of birth control for sexually active women taking Accutane and until one month after terminating the drug.
Depression
Many studies have emerged linking isotretinoin to depression. The accutane label includes the following warning:
Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts,
suicide, and aggressive and/or violent behaviors.
Other Side Effects
Dry and cracked lips, Dry skin, Dry nostrils, Dry eyes, Dry genitals and anal mucosa, Fragile skin, Eczema, Hair loss, Nail changes, Muscle aches, Tiredness, Eye problems, Hypertriglyceridaemia, colitis and tinnitus.
Controversy
Isotretinoin has been surrounded in controversy since it's inception. It was seen by some as being rushed through the approval phase in the FDA (taking much less time than the average for approval).
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