SummaryOral Isotretinoin is a member of the retinoid class of acne medications. Retinoids can help improve acne symptoms by decreasing the amount of sebum "oil" that is produced by the sebaceous glands.
Overall, Isotretinoin is rated as a Good treatment for acne. Users report that, Isotretinoin is Mostly Effective for improving symptoms and that this medication tends to have Significant side effects.
How it Works: Isotretinoin inhibits the activity of the sebaceous glands and decreases the production of sebum. Excess sebum production can lead to clogged pores the growth of acne-causing bacteria.
When is this medication used? Oral isotretinoin is usually reserved for the treatment of moderate to severe acne symptoms (Acne Types: 3-4). Isotretinoin may also be used to treat non-typical acne (eg. Acne Fulminans).
Official Name: Isotretinoin.
Popular Brand Names: Accutane, Amnesteem, Isotane, Sotret, Oratane and Roaccutane.
Oral Isotretinoin and Acne Treatment
Isotretinoin therapy can permanently decrease the size and activity of the sebaceous glands, remedying one of the primary causes of acne vulgaris. While the exact biological mechanism of isotretinoin is poorly understood, isotretinoin therapy appears to decrease the number of actively proliferating sebocytes at the base of the sebaceous glands. Isotretinoin may also lead to changes in the composition of the sebum produced by the sebaceous glands, although this is effect is not well studied.
Ultimately, the decrease in sebum production leads to a decrease in the amount of nutrients available for the growth of bacteria, such as Propionibacterium acnes, which use sebum as a source of nutrition. Since bacteria are a primary cause of the inflammation associated with severe acne, this decrease in the population of bacteria can greatly improve symptoms in people with inflammatory acne.
A decrease in the amount of sebum can also decrease the formation follicular plugs (clogged pores) that further contribute to the development of acne symptoms. Isotretinoin may also increase cellular turnover in the epidermis and prevent hyperkeratinization of the follicle. While sebum levels usually return to near-normal levels after completion of the treatment, acne relief often persists for an extended period, and is permanent for many patients. This lasting effect is likely due to fundamental physiological changes in the sebaceous glands, sebum and the physiology of the hair follicle itself.
For many people, isotretinoin treatment yields wonderful results and clear skin for the first time in years, but as with any medication, it is critical to understand how the drug works, and the potential side effects and contraindications before beginning a treatment plan. In cases of severe acne, dermatologists may also prescribe topical or oral antibiotics in order to further suppress bacterial growth and accelerate the resolution of acne symptoms.
Oral Isotretinoin Patient Reviews
Isotretinoin is often very effective at treating severe acne. However, there are also several potential side effects associated with this medication. Patient reviews are widely distributed between positive and negative. This variation reflects how acne patients view the balance between the costs and benefits of isotretinoin therapy.
Reviewers from The Science of Acne have rated oral isotretinoin as generally effective, but with moderate to severe side effects. For a complete breakdown of how this medication ranks click on the ranking “gauge” or click here.
If you have used oral isotretinoin (Accutane) as a treatment for acne, please rate your personal experience with this medication.
Isotretinoin Availability and Cost
Isotretinoin became available in generic form in 2003 and is now produced under numerous names by a wide range of generic pharmaceutical companies. In 2010, Roche (the manufacturer of brand name Accutane) withdrew the product in several countries, citing competition from generics and the cost of ongoing litigation. While Accutane is widely available as a generic, it is still relatively expensive.
If possible, isotretinoin should be obtained with the consultation and oversight of a qualified medical professional. Most physicians and dermatologists are familiar with this medication. However, many doctors are unwilling or unable to prescribe isotretinoin to patients. This reluctance stems from both the potential for complications, and also the exposure to legal liability in countries like the United States. Some doctors may be unable to prescribe isotretinoin because of restrictions related to their malpractice insurance.
In addition to the restrictions, many countries require supplemental testing and monitoring during the use of isotretinoin. Because of the high risk of severe birth defects if isotretinoin is taken by pregnant women (or women who become pregnant during treatment), many medical guidelines suggest that physician’s verify that a woman is not pregnant prior to beginning treatment, and that women are using two independent forms of birth control during treatment.
The ongoing monitoring and testing, combined with the cost of the medication itself, can make isotretinoin treatment very expensive. Even with decent insurance coverage, the total cost of isotretinoin therapy is likely to exceed $1,000 (USD).
Isotretinoin Dosage Information
Isotretinoin is often prescribed at a dose of .5-1 mg/kg/day, which works out to about 40-60 mg/day for most individuals. Lower dosages, 20-40 mg/day, have also been shown to be effective. While both the low dosage and high dosage regimens are effective at clearing acne, most research has suggested that it is the cumulative amount of isotretinoin administered that matters the most when it comes to long term control of acne symptoms. Generally speaking, a normal course of isotretinoin treatment will include a cumulative intake of roughly 10,000 mg of isotretinoin.
The severity of the side effects associated with isotretinoin treatment are directly related to the dosage amounts. While the general consensus is that it is better to administer relatively high dosages for a shorter period of time, there is also research indicating that low dosages regimens are also effective, but have fewer side effects.
Isotretinoin is chemically similar to vitamin A, a fat soluble (lipophilic) vitamin. Because of this, isotretinoin is also lipophilic and is absorbed more efficiently by the body when taken with a high fat meal. Patients are also advised to avoid vitamin A supplements during isotretinoin therapy because this increases the risk of hepatotoxicity (liver problems).
Side Effects of Isotretinoin Therapy
Isotretinoin (Accutane) is perceived by many people as a highly toxic and dangerous medication. Isotretinoin is a powerful medication that can have adverse effects. However, although certainly are side effects to isotretinoin therapy, some of this negative perception is not based on solid epidemiological data.
If you have used oral isotretinoin (Accutane) as a treatment for acne, please rate your personal experience with this medication.
Because isotretinoin affects many different types of cells throughout the body, it has a wide range of potential side effects. The majority of the most common side effects (eg. dry skin) are fairly mild, although serious side effects can also occur. Below is a summary of the most common and/or serious potential complications.
For more in-depth information about potential side effects of oral isotretinoin therapy, refer to the physician’s insert for isotretinoin family antibiotics, or consult a medical professional. For more information about contraindications in general, refer to Avoiding Negative Drug Interactions.
Isotretinoin and Pregnancy
The single most serious side effect of accutane treatment is it’s impact on the development of a fetus. Isotretinoin disrupts the carefully balanced processes of cellular differentiation and dorsal-ventral patterning that are critical in the development of an embryo. This is true not only in humans, but in most (if not all) animals. Even small amounts of isotretinoin can cause severe birth defects and/or death of the fetus. It is therefore absolutely necessary to avoid taking isotretinoin while pregnant, or becoming pregnant while on accutane.
In the United States, the law dictates that all women must be on two forms of birth control while undergoing isotretinoin treatment. Largely because of the risk of serious birth defects, acne patients are required to enroll in a program called iPLEDGE prior to treatment, the primary role of which is to prevent pregnancy during isotretinoin treatment.
While no data suggests that a male taking isotretinoin can induce birth defects in a female partner, it is advisable to avoid any unprotected sex while undergoing isotretinoin therapy.
Dry Skin and Hair
Dry skin and hair are the most common side effect of isotretinoin therapy, affecting nearly every patient. The extent of the dryness mainly depends on the dosage of isotretinoin, and symptoms can range from mild to severe. These symptoms are caused by the large decrease in sebum production that occurs as a result of isotretinoin therapy. While excess sebum is one of the causes of acne, sebum is also an important part of the natural mechanism that keeps your skin and hair properly hydrated and protected. This can lead to chapped lips, brittle hair, cracking of mucus membranes (e.g. nasal passages) and very dry skin.
Most people find that they need to frequently apply moisturizer and chapstick to pretect their delicate skin. Non-oil based moisturizers (eg. Cetaphil) are usually more effective than common hand lotions. Make sure to check that the moisturizing products are non-comedogenic. Isotretinoin also increases sensitivity to the sun and magnifies the severity of sunburns.
Isotretinoin has been implicated in over 60 suicides over the last two decades. However, the actual relationship between isotretinoin treatment and a complicated, multi-factorial condition like depression is questionable. One of the main complicating factors is the relationship between acne vulgaris, depression and suicide. As anyone who has suffered with acne knows, it is hard to imagine many things more psychologically painful than having to face a social situation, or even one’s self in the mirror, when experiencing a bad outbreak.
Sociological and psychological research clearly supports the connection between acne vulgaris and depression. The more severe the acne symptoms, the higher the risk of a patient experiencing symptoms of low-self esteem and depression. However, the connection between isotretinoin therapy and depression is highly controversial. There has been some research that indicates a connection, but other research indicates that there is no connection.
In animal studies, mice being administered high doses of isotretinoin did show some signs of depression. Subsequent analysis of the brains of these mice showed changes in the distribution of brain activity during treatment. However, similar experiments in rats showed no major changes. Mice and rats are obviously not humans (and are not even closely related to humans), so it is difficult to extrapolate this type of research to human behavior. Therefore, the relationship between isotretinoin and depression remains poorly defined. To be on the safe side however, patients and physicians are generally advised to be aware of any behavioral and psychological changes that may occur during treatment and to consult a professional if the onset of depressive symptoms is suspected.
There are currently several lawsuits being pursued against the pharmaceutical company Roche alleging that treatment with accutane caused ulcerative colitis, a severe form of irritable bowl syndrome (IBS). While the direct connection between isotretinoin and ulcerative colitis is questionable (and largely anecdotal), it should be noted that at least two juries have awarded damages to the plaintiffs in these type of cases.
It is certainly possible that isotretinoin therapy contributes to the development of ulcerative colitis, although there are obviously other causes as well (because lots of people who never used isotretinoin also have ulcerative colitis. The main difficulty in assigning blame is that ulcerative colitis is a generic name for a symptom, and does not necessarily imply a particular cause. For example, both bacterial infection and auto-immune disorders have also been implicated as the cause of ulcerative colitis.
Joint Pain and Muscle Fatigue
Pain in the joints and muscles is a commonly reported side effect of isotretinoin therapy. Many patients also report chronic fatigue and lethargy during treatment. Isotretinoin may temporarily decrease athletic performance and slow healing times, although these side effects are not well studied.
Additional Side Effects of Oral Isotretinoin Therapy
Patients may develop an increase in blood cholesterol and triglycerides. In many cases, frequent blood tests are done to monitor the levels of these molecules in the blood. Rarely, isotretinoin can cause brain swelling (intracranial hypertension), which produces nausea, vomiting, headache, and changes in vision. Isotretinoin is contraindicated with tetracycline family antibiotics, which may exacerbate problems with brain swelling. Isotretinoin is also contraindicated in nursing mothers. A complete discussion of potential side effects can be found in the Package Insert for isotretinoin.
Isotretinoin (Accutane) is a powerful anti-acne drug that is usually reserved for patients with moderate and severe acne that have not responded well to other treatments. Isotretinoin is one the most effective (and controversial) treatments for acne vulgaris. It is one of the few treatments that offers the possibility of a permanent relief from acne vulgaris symptoms. For some acne patients, isotretinoin can lead to life changing improvements in their acne. However, the effectiveness of isotretinoin is counter-balanced by the potential for negative side effects with isotretinoin therapy.
Isotretinoin is a part of a family of naturally occurring molecules called retinoic acids. Retinoic acids play a central role in controlling the growth and differentiation of cells. Their are many different types of retinoic acids, and this diverse group of molecules has unique effects on a range of different types of cells.
Isotretinoin (and the natural metabolites that are created in the body) effect the growth of the sebaceous glands, which produce sebum. Isotretinoin also affects many other biological processes that are unrelated to acne – a feature which leads to many potential side effects.
Additional Names for Oral Isotretinoin: 13-cis-Retinoic Acid, Accuran, Accure, Accutin, Acnecutan, Acnemin, Acnetane, Acnotin, Aknenormin, Aknetrent, Atretin, Ciscutan, Claravis, Clarus, Contracné, Curacne, Curacné, Curakne, Curatane, Decutan, Dercutane, Farmacne, Inotrin, Isoacne, Isocural, Isohexal, Isotret, Isotretinoina, Isotretinoine, Isotrétinoïne, Isotretinoinum, Isotroin, Izotek, Lurantal, Nimegen, Piplex, Procuta, Roaccutan, Roacnetan, Roacutan, Sotret, Tretinac, Tretinak, Tretinex and Zoretanin.
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References and Sources
PDR Staff Writers. 2011. 2011 Physicians’ Desk Reference (Library/Hospital Version) (Physicians’ Desk Reference (Pdr))
Icon Group Staff Writers. 2009. Isotretinoin: Webster’s Timeline History, 1896 – 2007
Habif. 2009. Clinical Dermatology
Goodheart. 2006. Acne For Dummies
Bremner. 2011. The Goose That Laid The Golden Egg: Accutane – the truth that had to be told
Isotretinoin @ PubMed Health – The National Institute of Health (US) offers basic comprehensive information about most common medications.
Isotretinoin @ Wikipedia – Wikipedia is an excellent resource for learning about how medications work.
Isotretinoin Package Insert – The physician’s insert for a medication contains nearly all of the relevant information, including indications, dosage information and background data.
Isotretinoin @ WebMD – More information on this medication and it’s use. Includes user reviews.
Isotretinoin @ Acne.org – Includes many user reviews.
Scientific Research Articles
Coates, et al. 2005. Efficacy of oral isotretinoin in the control of skin and nasal colonization by antibiotic-resistant propionibacteria in patients with acne.
Ertam, et al. 2006. Is it necessary to have routine blood tests in patients treated with isotretinoin?
Ghaffarpour, et al. 2006. Oral isotretinoin for acne, adjusting treatment according to patient’s response.
Prokop, et al. 1999. Isotretinoin: possible component cause of inflammatory bowel disease.
Bruno, et al. 1984. Adverse effects of isotretinoin therapy.
Bankar, et al. 2006. Ulcerative colitis probably associated with isotretinoin.
Bernstein, et al. 2009. Isotretinoin is not associated with inflammatory bowel disease: a population-based case–control study.
Crockett, et al. 2010. Isotretinoin Use and the Risk of Inflammatory Bowel Disease: A Case–Control Study.
Reddy, et al. 2006. Possible association between isotretinoin and inflammatory bowel disease.
Crockett, et al. 2009. A causal association between isotretinoin and inflammatory bowel disease has yet to be established.
Magin, et al. 2005. Isotretinoin, depression and suicide: a review of the evidence.
Wysowski, et al. 2001. An analysis of reports of depression and suicide in patients treated with isotretinoin.
Rubinow, et al. 1987. Reduced anxiety and depression in cystic acne patients after successful treatment with oral isotretinoin.
Jacobs, et al. 2001. Suicide, depression, and isotretinoin: is there a causal link?
Marqueling, et al. 2007. Depression and suicidal behavior in acne patients treated with isotretinoin: a systematic review.
Wolkenstein, et al. 2010. Isotretinoin, Depression, and the Media.
Kaymak, et al. 2009. Comparison of depression, anxiety and life quality in acne vulgaris patients who were treated with either isotretinoin or topical agents.
Uhlenhake, et al. 2010. Acne vulgaris and depression: a retrospective examination.
Rademaker, et al. 2010. Adverse effects of isotretinoin: A retrospective review of 1743 patients started on isotretinoin.
Kontaxakis, et al. 2009. Isotretinoin and psychopathology: a review.
Ghalamkarpour, et al. 2006. Isotretinoin in treatment of acne: its efficacy, side effects, and recurrence rate of disease.
Kaymak, et al. 2006. Incidence of depression related to isotretinoin treatment in 100 acne vulgaris patients.
Schroeder, et al. 2007. All-trans-retinoic acid and 13-cis-retinoic acid: Pharmacokinetics and biological activity in different cell culture models of human keratinocytes.
Dreno, et al. 2006. An expert view on the treatment of acne with systemic antibiotics and/or oral isotretinoin in the light of the new European recommendations.
Wysowski, et al. 2002. Use of isotretinoin (Accutane) in the United States: Rapid increase from 1992 through 2000.
Rigopoulos, et al. 2010. The role of isotretinoin in acne therapy: Why not as first-line therapy? Facts and controversies.
Dhir, et al. 2008. Oral isotretinoin is as effective as a combination of oral isotretinoin and topical anti-acne agents in nodulocystic acne.
Nelson, et al. 2006. 13-cis-retinoic acid induces apoptosis and cell cycle arrest in human SEB-1 sebocytes.
Plewig, et al. 2004. Low dose isotretinoin combined with tretinoin is effective to correct abnormalities in acne.
Ellis, et al. 2001. Uses and complications of isotretinoin therapy.
Ng, et al. 1999. Treatment outcome of acne vulgaris with oral isotretinoin in 89 patients.
Quereux, et al. 2006. Prospective study of risk factors of relapse after treatment of acne with oral isotretinoin.
Akman, et al. 2007. Treatment of acne vulgaris with intermittent and conventional isotretinoin: a randomized, controlled multicenter study.
Borghi, et al. 2011. Low-cumulative dose isotretinoin treatment in mild-to-moderate acne: Efficacy in achieving stable remission.
Lee, et al. 2011. Effectiveness of conventional, low-dose and intermittent oral isotretinoin in the treatment of acne: A randomized, controlled comparative study.
Al-Mutairi, et al. 2005. Isotretinoin in acne vulgaris: a prospective analysis of 160 cases from Kuwait.
Amichai, et al. 2006. Low-dose isotretinoin in the treatment of acne vulgaris.