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Isotretinoin

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Isotretinoin is a prescription drug used for the treatment of severe acne. Isotretinoin belongs to a family of drugs called retinoids. Similar medications include tretinoin (Retin-A) and alitretinoin (Panretin). Isotretinoin is a very effective treatment for acne but carries a significant risk of birth defects. The drug is also being studied for use as a possible chemotherapeutic agent for several different types of cancer.

Contents

Other Names

  • 13-cis retinoic acid

Uses

Accutane is specifically indicated for the treatment of severe recalcitrant (not responsive to treatment) nodular acne (acne presenting with many nodules that are >5mm in diameter).

How Isotretinoin is Taken

Isotretinoin is marketed as 10 mg, 20 mg and 40 mg soft gelatin capsules for oral use. The recommended dose for Accutane is 0.5-1.0 mg/kg per day given in two divided doses for 15-20 weeks.

Accutane is always to be taken with food and a full glass of water. The drug needs to be protected from sunlight.

How Isotretinoin Works

The exact mechanism of action of isotretinoin is not understood. However, isotretinoin is known to inhibit sebaceous gland function and keratinization of the skin.

How the Body Affects Accutane

Due to its high fat solubility, absorption of isotretinoin is maximized when taken with a high-fat meal (therefore, Accutane should always be taken with food).

The body metabolizes isotretinoin into three active metabolites via the liver enzymes CYP2C8, CYP2C9, CYP3A4, and CYP2B6. All three of these metabolites possess retinoid activity that is more potent than that of the parent isotretinoin.

The metabolites of isotretinoin are ultimately excreted in the feces and urine in relatively equal amounts (total of 65% to 83%).

Side Effects

The most common side effects observed with the use of isotretinoin are:

  • Conjunctivitis ("pinkeye")
  • Dry or fragile skin
  • Dry or cracked lips
  • Dry mouth
  • Dry nose
  • Itching
  • Joint pains
  • Nosebleed
  • Decreased night vision
  • Scarring with cosmetic procedures (waxing, dermabrasion or laser procedures)
  • Skin reactions to sunlight and ultraviolet light

More serious side effects include:

  • Headaches, nausea, vomiting or blurred vision
  • Depression or changes in mood, such as feelings of sadness or irritability
  • Unusual tiredness or lack of appetite
  • Severe stomach pain, diarrhea or bleeding from the rectum
  • Very dry eyes
  • A yellow color to the skin or eyes (jaundice)

A doctor may advise discontinuing the medication if these side effects occur.

Risks

Complications

An unborn baby could develop severe birth defects if the mother becomes pregnant while taking isotretinoin. There is also an increased risk of spontaneous abortion and premature birth with use of the drug. The ipledge program is a web-based risk management program designed to eliminate exposure to isotretinoin to a fetus by restricting the distribution of the drug. The patient must use two forms of birth control, be counselled about the risk of birth defects with isotretinoin, and take a pregnancy test before starting the medication. Patients are generally given a one-month supply of isotretinoin at a time and required to take a pregnancy test and be re-counseled about the risks of pregnancy before receiving a new prescription.

Interactions

The following drugs are known to interact with isotretinoin:

Effectiveness

Isotretinoin is capable of producing long-term remission in the majority of acne patients. A study showed that two-thirds of patients taking isotretinoin at a dose of 0.5 to 1 mg/kg/day remained acne-free ten years after treatment. Of those who relapsed, 16% required a course of antibiotics and 23% required additional treatment with isotretinoin. The relapse rate appeared to be related to the cumulative dose of isotretinoin. [1]

History

  • Accutane is marketed by Roche Pharmaceuticals.
  • FDA approval was granted in 1982.
  • The ipledge program was started in 2005.

Controversy

There is some debate over whether or not isotretinoin causes adverse psychiatric effects. These effects have been listed as depression, psychosis, mood swings, violent behavior, suicide, and suicide attempts. A Medline review showed that despite anecdotal and epidemiologic studies, a lack of concrete data exists to back up these claims. [2] A more recent article reports a causal relationship between isotretinoin and depression. [3]

Research

Recent discoveries

A recent study looked at recognizing predictive factors for a flare-up of acne at the onset of isotretinoin treatment in an effort to prevent flares and associated scarring. [4]

The use of oral isotretinoin has also been studied and may be effective at improving the effects of photoaging of the skin. [5] [6]

Future research

There are a number of ongoing studies regarding the use of isotretinoin for treatment of various cancers. These include:

  • Using isotretinoin in combination with Vitamin E to prevent lung cancer in smokers. The vitamin E may mitigate the side effects of the isotretinoin. [7]
  • The safety and efficacy of treating cervical tumors in HIV positive women with isotretinoin. [8]
  • Using isotretinoin in combination with MS-275 (a chemotherapeutic agent) in treating patients with solid tumors or lymphoma. [9]
  • The use of isotretinoin in the prevention of skin cancer. [10]

More studies are ongoing or recently completed regarding the role of isotretinoin (usually in combination with other drugs) in the treatment of:

Clinical Trials

A list of clinical trials is available at here: Isotretinoin clinical trials.

References

  1. ↑ Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris--10 years later: a safe and successful treatment. Br J Dermatol. 1993 Sep;129(3):292-6. Abstract
  2. ↑ Strahan JE, Raimer S. Isotretinoin and the controversy of psychiatric adverse effects. Int J Dermatol. 2006 Jul;45(7):789-99. Abstract
  3. ↑ Azoulay L, Blais L, Koren G, LeLorier J, Berárd A. Isotretinoin and the risk of depression in patients with acne vulgaris: a case-crossover study. J Clin Psychiatry. 2008 Apr;69(4):526-32. Abstract
  4. ↑ Demircay Z, Kus S, Sur H. Predictive factors for acne flare during isotretinoin treatment. Eur J Dermatol.2008 Jun 23;18(4):452-456. (Epub ahead of print) Abstract
  5. ↑ Kalil CL, Fachinello FZ, Lamb FM, Comunello LN. Use of oral isotretinoin in photoaging therapy. Skinmed 2008 Jan-Feb;7(1):10-4. Abstract
  6. ↑ Hernandez-Perez E, Khawaja HA, Alvarez TY. Oral isotretinoin as part of the treatment of cutaneous aging. Dermatol Surg. 2000 Jul;26(7):649-52. Abstract
  7. ↑ ClinicalTrials.gov web site. Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer.
  8. ↑ ClinicalTrials.gov web site. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors.
  9. ↑ Clinicaltrials.gov web site. MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas.
  10. ↑ ClinicalTrials.gov web site. Isotretinoin in Preventing Skin Cancer

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