Acne Medication Side Effects

Isotretinoin (INN) (pronounced /ˌaɪsoʊtrɨˈtɪnɵʊɨn/ ) is a medication used for the treatment of severe acne. It was first developed to be used as a chemotherapy medication for the treatment of brain cancer, pancreatic cancer and more. It is still used in the treatment of these cancers to this day because of its ability to kill rapidly dividing cells. The effects of the medication are systemic and non-selective. In some cases, it is used to treat Harlequin type ichthyosis, a usually lethal skin deformation in which sufferers develop armor plated-like skin and usually die soon after birth. It is a retinoid, meaning it derives from vitamin A and is found in small quantities naturally in the body. Oral isotretinoin is marketed under various trade names, most commonly Roaccutane (Hoffman-La Roche; simply Accutane before July 2009), Amnesteem (Mylan), Claravis (Barr), Clarus (PremPharm), Decutan (Actavis), Isotane (Pacific Pharmaceuticals), Izotek (BlauFarma), Oratane (Genepharm Australasia), ISOTRET (Liva Healthcare Ltd.) or Sotret (Ranbaxy), while topical isotretinoin is most commonly marketed under the trade names Isotrex or Isotrexin (Stiefel).

History

An early, effective treatment of acne first used during the 1930s was high doses of the fat-soluble vitamin A (retinoic acid). At these dosage levels (sometimes 500,000 IU per day), sebum production is notably reduced, thwarting acne, but overly dry hair is a negative side effect, and such high doses can lead to vitamin A toxicity. Use of animal-based vitamin A at nutritive levels (where the upper limit dosage is 10,000 IU daily), taken over the course of a year, has also been shown to reduce acne. One positive side effect is that patients tend to be healthier, as present diets often do not include enough fat-soluble vitamin A.

Building on the discovery that vitamin A can reduce sebum production at toxic dosages, the retinoic acid derivative isotretinoin (13- cis -retinoic acid) was developed and released in 1982 by Hoffmann-La Roche. The advantage of the synthetic compound is an overall better success at treating acne. When compared to toxic dosages of Vitamin A, the side effects are reduced.

Dosage requirements of isotretinoin have been disputed. Due to a 1984 study funded by Roche, relatively high dosages of isotretinoin became mainstream in treatment in the United States. Lower dosages were found to be effective in treatment by independent research (see dosage section of this article) in countries outside the U.S., where the funding was through socialized medicine.

From the time of its introduction, the drug was known to have teratogenic potential, and pregnancies with the drug were strongly discouraged. When they occurred, they were found to have approximately 30% rates of congenital malformation, versus a 3-5% baseline risk. Beginning in 1998, prescriptions of the drug came under scrutiny, as fewer than half of prescribers were testing for pregnancy, usually relying on less sensitive urine tests. On the grounds that pregnancies by women taking the drug had been underreported by the manufacturer between 1982 and 2000, and that once generic manufacturers entered the market risk management was no longer centralized, the FDA instituted restrictions on prescribing and dispensing the drug, first with the "System to Manage Accutane Related Teratogenicity" (SMART) in 2000, and subsequently the iPLEDGE program in 2006. A retrospective cohort study recently found that pregnancy rates were quite high during the period (1 per 30 women per year), and 84% of pregnancies were ended by induced abortion.

In February 2002, Roche's patents for isotretinoin expired and there are now many other companies selling cheaper generic versions of the drug. On June 29, 2009 Roche Pharmaceuticals, the original creator and distributor of isotretinoin, officially discontinued both the manufacture and distribution of their Accutane brand in the United States due to what the company described as business reasons related to low market share (below 5 percent) coupled with the high cost of defending personal-injury lawsuits brought by some patients prescribed the drug. Generic isotretinoin will remain available in the United States through various manufacturers. Roche USA continues to defend Accutane and claims to have treated over 13 million patients since its introduction in 1982. F. Hoffmann-La Roche Ltd. apparently will continue to manufacture and distribute Roaccutane outside of America.

Isotretinoin is available over the internet from countries where it can be dispensed without a prescription. This presents a dilemma for acne sufferers residing in countries with highly regulated medical and pharmaceutical industries (FD&C Act), as private importation might violate existing statutes.

Pharmacodynamics

Isotretinoin's exact mechanism of action is unknown. Recent research suggests that the drug may amplify production of the antimicrobial protein neutrophil-gelatinase associated lipocalin in the skin, thereby reducing sebum production. Generally, it is thought that similar to other retinoids, the drug alters DNA transcription. The drug decreases the size and sebum output of the sebaceous glands. It also stabilizes keratinization, makes the cells that are sloughed off into the sebaceous glands less sticky, and therefore inhibits the formation of comedones. Isotretinoin's combined impact on several of acne's contributory factors distinguishes isotretinoin from alternative remedies such as antibiotics and accounts for its greater efficacy in severe, nodulocystic cases.

New studies have linked retinoids and other similar chemotherapy agents to telomere shortening, causing many to believe that telomere shortening is accutane's mechanism of action. Telomere shortening leads to an increase in the rate of cell death within the body, which could possibly explain why accutane causes side-effects such as pre-epiphyseal closure, depression, and others.

The effect on sebum production is temporary. However, remission of the disease can be "complete and prolonged."

Pharmacokinetics

Isotretinoin, when administered orally, is best absorbed when taken after a high fat meal, as it has a high level of lipophilicity. In a crossover study, it was found that the peak plasma concentration more than doubled when taken after a high fat meal versus a fasted condition. Isotretinoin is primarily (99.9%) bound to plasma proteins, mostly albumin. At least three metabolites have been detected in human plasma after oral administration of isotretinoin. These are 4-oxo-isotretinoin, retinoic acid and 4-oxo-retinoic acid. Isotretinoin also oxidizes, irreversibly, to 4-oxo-isotretinoin. The metabolites of isotretinoin are excreted through both urine and feces. The mean elimination half-life is 21 hours, with a standard deviation from this mean of 8.2 hours.

Clinical use

Except in the most severe cases, isotretinoin is used only after other acne treatments fail to produce results. Treatment of acne usually begins with topical medications (e.g. benzoyl peroxide, adapalene, etc), followed by oral antibiotics (or a combination) and finally isotretinoin therapy. This is because other treatments, while less effective than isotretinoin, are thought to be associated with fewer adverse effects and lower cost. The higher cost is due to the medical supervision required in taking a toxic dosage. The cost of the medicine is also a factor (example: taking 5, 10, or even 20 mg daily is far less expensive than taking 80 mg daily).

Indications

Isotretinoin is indicated for the treatment of severe cystic acne vulgaris. Many dermatologists also support its use for treatment of lesser degrees of acne that prove resistant to other treatments, or that produce physical or psychological scarring.

It is also effective for hidradenitis suppurativa and some cases of severe acne rosacea. It can also be used to help treat harlequin ichthyosis, and is used in xeroderma pigmentosum cases to relieve keratoses. Isotretinoin has been used to treat the extremely rare condition Fibrodysplasia Ossificans Progressiva. It is also used for treatment of neuroblastoma, a form of brain cancer.

Prescribing restrictions

In the United Kingdom, this drug may only be prescribed by, or under the supervision of, a consultant dermatologist. Because severe, cystic acne has the potential to cause permanent scarring over a short period, restrictions on isotretinoin's more immediate availability have proved contentious. Similar restrictions are common in most Australian states – in New South Wales and Victoria, for instance, the prescriber must be a Fellow of the Australasian College of Dermatologists (FACD). In New Zealand, isotretinoin can be prescribed by any doctor but is subsidised only if prescribed by a vocationally registered general practitioner or dermatologist.

Since 1 March 2006, the dispensing of isotretinoin in the United States has been controlled by a FDA-mandated website called iPLEDGE – dermatologists are required to register their patients before prescribing and pharmacists are required to check the website before dispensing the drug. The prescription may not be dispensed until both parties have complied. A physician may not prescri

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