Acne is a combined hormonal (androgen) and bacterial disorder.Androgens stimulate sebaceous glands to produce larger amounts of sebum.The increased amount of sebum can result in hyperkeratinization of the lining of the follicle which may cause plugging.

Accutane improves nodular acne in association with a reduction in sebum secreation, reduction in sebaceous gland size, and an inhibition of sebaceous gland differentiation. It is known that isotretinoin exerts antiproliferative and antiandrogenic effects on sebaceous glands and can reduce lipid synthesis in sebocytes.There is reason to believe that acne may be a disease of reduced retinoid signaling that leads to localized vitamin A deficiency in the sebaceous follicle. 

The exact mechanism by which Accutane works is not known.

My Opinion

Roche Pharmaceuticals states that, “because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.”Nodular acne, a type of acne vulgaris, extends into deeper layers of the skin and may cause tissue destruction that results in 

My Opinion Continued

scarring. Nodular acne is a severe form of acne and may be very painful.

I suspect, with the prolific cosmetic desires of acne patients in the U.S., that Accutane®is over-prescribed for less severe types of acne vulgaris.I fear that too many 12 – 17 year-olds, for whom it is very natural to have pimples, take Accutane because our culture tells them that a person should not have any pimples.

Nutritional Concerns 

It has been shown that Accutane can decrease the calcium levels in the body and it could be beneficial to take supplemental calcium during the course of therapy.A daily dosage of 1000 mg is within the common range of supplementation and is generally considered safe.

Sources

Marieb, Elaine N.Human Anatomy and Physiology,Fifth Edition.Benjamin Cummings 1999

Journal of the American Academy of Dermatology. Volume 45 • Number 5 • November 2001. 

The New England Journal of Medicine.Volume 313:837-841October 3, 1985 “Number 14 Retinoic acid embryopathy”

http://www.rocheusa.com/products/accutane/Copyright ©  2002-2003 Hoffmann-La Roche Inc. “Complete Product Information”

Dave Gates January 30, 2003
 

Manufactured by Roche Pharmaceuticals

An Oral Acne Medication

The active ingredient in Accutane® is Isotretinoin (13-cis-retinoic acid) (synthetically produced)

Isotretinoin’s generic name is retinoic acid (which is naturally occurring)

Other trade names of Isotretinoin:Roaccutane®

Vitamin A-deficient animals manifest altered skin keratinization, therefore retinoids have been topically and systemically administered for the treatment of disorders of keratinization including acne.

Cost:For a 40 mg 2 times per day (a typical dose) Accutane costs $400 - $500 per month.That could be about $1900 for one course of Accutane (12 –15 weeks).

Isotretinoin and vitamin A (a.k.a. retinol) are known as retinoids.Retinoids have critically important effects on numerous fundamental biologic processes including vision, reproduction, embryogenesis, carcinogenesis, growth, and differentiation.And as a result many of Accutane’s side effects are associated with these biologic processes.

Side Effects

There is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time.

Accutane may cause depression, psychosis, and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.

Accutane has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.Symptoms are papilledema, headache, nausea and vomiting, and visual disturbances.

Acute pancreatitis, Cardiovascular consequences, Impaired hearing, Clinical hepatitis, inflammatory bowel disease, Visual problems, and increased sensitivity to UV rays or sunlight and contact lensesare other side effects. Wax epilation and skin resurfacing procedures (such as dermabrasion and laser) should be avoided during, and at least six months thereafter, due to the possibility of delayed healing or exuberant granulation of tissue with crusting and scarring. 

There is some evidence that long-term, high-dose, or multiple courses of therapy with Accutane have more of an effect than a single course of therapy on the musculoskeletal system.Studies have shown that use of Accutane can decrease bone density.Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been seen in the Accutane population.Hyperostosis is also possible.(16% of patients in a clinical trial developed musculoskeletal symptoms.)About 29% of pediatric patients developed back pain, it was severe in 13.5% of them.

Birth Defects

In order to be prescribed Accutane a woman must have two negative pregnancy tests, must be using two forms of contraceptives, must not be breast feeding, and must sign an Informed Consent/Patient Agreement form.

Roche has an 800-number for their own Pregnancy Prevention Program Specialists whom you should call if you become pregnant while taking Accutane®.They will offer advice, including abortion advice.

A study, published by The New England Journal of Medicine, investigated 154 human pregnancies with fetal exposure to isotretinoin.The outcomes were 95 elective abortions, 26 infants without major malformations, 12 spontaneous abortions, and 21 malformed infants. 

Studies have indicated that there are no long-term birth-defect risks from taking Accutane.Children that have been conceived one month after Accutane therapy has ceased have been born with no more birth defects than the general population.

Drug Interactions

Patients should not use St. John’s Wort because of possible interaction with it and hormonal contraceptives.

They should not take vitamin A, which may worsen side effects of Accutane and cause addictive toxic effects.

They should not take tetracyclines, micro-dosed progesterone (a form a birth control that may not be effective while using Accutane), Phenytoin (a drug that has decreased-bone-density side effects), or systemic corticosteroids (know to cause osteoporosis).

Accutane is a serious drug.

To prescribe Accutane, a doctor must read and sign Roche’s System to Manage Accutane Related Teratogenicity (SMART) Guide to Best Practice, which is a document that explains the risks of this drug to pregnant women.Once the doctor has signed and mailed this form in she will obtain a supply of yellow self-adhesive Accutane Qualification Stickers, without which Accutane will not be prescribed.

A script with the sticker must be filled within 7 days of when the script was written.No refills will be dispensed without a new, written script.Only 30 days worth of Accutane will be dispensed at one time.Law requires that an Accutane Medication Guide is given each time the drug is dispensed.

The Positives

Although Accutane has many very dangerous side effectsit is a very successful acne treatment andmany people who have used the drug are very happy with the results.