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Non-acne dermatologic indications for systemic isotretinoin

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Initial worsening of acne; xerosis and cheilitis; retinoid dermatitis; epistaxis; staphylococcal infections of the skin, often of the nail folds, to cause paronychia; 13 pyogenic granulomas of the nail folds are often seen on the toes; 17 hypertrophic scarring and keloids - dermabrasion should be delayed after isotretinoin because severe hypertrophic scarring may result; 18,19 hypertrophic scarring has been reported when isotretinoin was administered 2 months after dermabrasion 20 and also spontaneously, without prior surgery, on isotretinoin therapy.

Ocular complications. Dry eyes that can persist indefinitely; 22 blepharoconjunctivitis; keratitis with corneal ulceration is rare; 13 recent use of isotretinoin is a contraindication to laser refractive eye surgery; decreased night vision is a common and potentially dangerous side-effect, making driving a vehicle at night hazardous and is the reason why aviation pilots may not use the drug.

Night blindness can persist indefinitely. Laboratory abnormalities. Liver enzyme disturbance; raised serum lipids especially triglycerides. Central nervous system abnormalities.

Raised intracranial pressure - isotretinoin must not be combined with tetracyclines 23 or vitamin A. Mood disturbance, depression, inability to concentrate and study - this is controversial as large studies do not show an increase in depression and suicide ideation in isotretinoin users.

The British Association of Dermatologists recently reviewed psychiatric side-effects. Musculoskeletal abnormalities. CK-levels may become markedly raised. Decreased bone density does not occur in young people taking regular dosages of isotretinoin, 27 but it has been demonstrated where vitamin D deficiency co-existed. This has not been studied, probably because the rest of the world does not follow this practice.

No data exist on bone density in year-old patients who had previously taken low dosages of isotretinoin for 5 years. Diffuse idiopathic skeletal hyperostosis DISH can occur at higher dosages used for prolonged periods. The spinal ligaments are particularly prone to this complication. No data exist on this effect when low dosages are used for long periods. Premature closure of epiphyses is possible. Gastro-intestinal side-effects. Ulcerative colitis is controversial; some studies 31 found that isotretinoin can cause ulcerative colitis, while others 32 deny it.

The possible association of ulcerative colitis with isotretinoin, resulting in court cases, is a reason for an ethical company withdrawing their isotretinoin from the market in the USA. The GA states that acne is cured when, after treatment is discontinued, no further treatment is required. A cure has been achieved if a recurrence is so mild that the patient does not deem treatment necessary. Problems in interpreting the literature mostly arise here. Differing definitions of a cure result in confusing conclusions from studies and the long-term effects of oral isotretinoin, e.

This is no cure by any standard and created a false impression of the results. The pitfalls of inappropriate use of oral isotretinoin. The pitfalls are largely medicolegal. The oral drug is slightly more effective, but topical retinoids have minimal risk and are therefore the maintenance drug of choice. A hypothetical malpractice court case where a prescribing physician is litigated against for the trauma of any of the complications listed, would be indefensible if the indications and dosing did not match the accepted, published guidelines at the time.

Lawyers would use evidence from the literature and any doubts will be applied in favour of the complainant. That such action would not hold up in court means that the patient's best interests are not taken into account when using oral isotretinoin inappropriately.

The fact that the patients often request, or force, doctors to prescribe it, does not relieve the responsibility to do the evidence-based correct thing. Why some dermatologists use isotretinoin in inappropriate dosing regimens and for the wrong indications. Patient pressure forcing doctors to comply to protect their client base. Teenage patients prefer to swallow a tablet to applying a daily messy cream. The drying effect of topical retinoids, although less than that of systemic retinoids, is often an excuse to use the systemic drug instead.

Many healthcare professionals are not aware of the published guidelines, especially those on topical retinoids and their excellent efficacy. Laziness, convenience. It is less effort to prescribe low-dose systemic isotretinoin, with few obvious side-effects, than a complicated topical retinoid, for which the patient must be educated, and continually motivated to use it.

Complacency about possible litigation. The 'I know best' attitude is rife in South Africa. Why we must adhere to accepted global guidelines on the use of systemic isotretinoin. The main reason is to protect patients against the drug's adverse effects. Some are potentially serious and the more the drug is used, the more likely these events will be encountered.

Healthcare professionals must be protected against litigation for possible negligence when not prescribing the drug according to the guidelines and adverse events occur. Patients who 'force' the doctor to prescribe the drug are often the first to litigate if something goes wrong. We cannot risk losing access to the drug, one of dermatology's most valuable assets, as a result of inappropriate use. The European restrictions prevent some deserving patients from accessing this drug.

The American Gynecological Society lobbied for its ban for years, and such actions should not be given more ammunition through our carelessness. Recommendations on the rational use of systemic isotretinoin. Lower than standard doses of oral isotretinoin should only be prescribed in exceptional cases, after all safer alternatives have been considered and used but failed, or were impractical to use.

It should never be used as primary therapy for moderate degrees of acne. We should follow the world-wide accepted guidelines for which there are very good reasons. Conflict of interest. The author is a member of the Global Alliance for the Improvement of Outcomes in Acne Vulgaris, sponsored in full through an unlimited educational grant from Galderma. This paper has been endorsed by the academic heads of dermatology in South Africa.

Isotretinoin for acne vulgaris - 10 years later: a safe and successful treatment. Br J Dermatol ; 3 Low dose isotretinoin combined with tretinoin is effective to correct abnormalities of acne. J Dtsch Dermatol Ges ;2 1 Effectiveness of conventional, low-dose and intermittent oral isotretinoin in the treatment of acne: a randomized, controlled comparative study. Br J Dermatol ; 6 Schwartz S. Low dose isotretinoin - what does the literature say?

SA Dermatology Review ;11 2 Sinclair W, Jordaan HF. Acne Guidelines update. S Afr Med J ; Management of acne: a report from a global alliance to improve outcomes in acne. J Am Acad Dermatol ;49 1 :S J Am Acad Dermatol ;S A review of the European Directive for prescribing systemic isotretinoin for acne vulgaris.

J Eur Acad Dermatol ; Layton A. The use of isotretinoin in acne. Dermatoendocrinology ;1 3 Vallance P. Drugs and the fetus. BMJ ; Low levels of alitretinoin in seminal fluids after repeated oral doses in healthy men. Clin Exp Dermatol ;36 s2 Treatment of acne with intermittent isotretinoin.

Br J Dermatol ; Ganceviciene R, Zouboulis CC. Isotretinoin: state of the art treatment for acne vulgaris. Exp Rev Dermatol ; Isotretinoin and pregnancy. J Am Acad Dermatol ;10 5 Pt 1 Kuenzli S, Saurat J-H. Dermatology Volume 2. London: Mosby, Minor malformations characteristic of the retinoic acid embryopathy and other birth outcomes in children of women exposed to topical tretinoin during early pregnancy. Am J Med Genet ; 2 Periungual and subungual pyogenic granuloma.

Keywords: Acne, hyperostosis, inflammatory back pain, sacroiliitis, spondyloarthropathy, systemic isotretinoin. Objectives: This study aims to investigate the frequency of musculoskeletal adverse effects in acne vulgaris patients receiving systemic isotretinoin treatment.

Patients and methods: Between January and December , a total of severe acne patients 22 males, females; mean age: Data including age, sex, body mass index BMI , duration of disease, diagnosis, and comorbidities were recorded. Results: The treatment period was mean 8. The dose of isotretinoin was mean 0. Musculoskeletal side effects were seen in 99 Back pain was reported during the treatment period in 78 The diagnosis was mechanical back pain in 31 Creatine kinase elevation was reported in 18

❿  


- Systemic isotretinoin



  Systemic isotretinoin has been used to treat severe acne vulgaris for 20 years. However, isotretinoin also represents a potentially useful choice of drugs. Systemic isotretinoin remains the most efficacious treatment for severe acne as well as many cases of more moderate disease that are unresponsive to other.     ❾-50%}

 

- Systemic isotretinoin



    Initial worsening of acne; xerosis and cheilitis; retinoid dermatitis; epistaxis; staphylococcal infections of the skin, often of the nail folds, to cause paronychia; 13 pyogenic granulomas of the nail folds are often seen on the toes; 17 hypertrophic scarring and keloids - dermabrasion should be delayed after isotretinoin because severe hypertrophic scarring may result; 18,19 hypertrophic scarring has been reported when isotretinoin was administered 2 months after dermabrasion 20 and also spontaneously, without prior surgery, on isotretinoin therapy. J Am Acad Dermatol ;54 4 A written informed consent was obtained from each patient.

Night blindness can persist indefinitely. Laboratory abnormalities. Liver enzyme disturbance; raised serum lipids especially triglycerides. Central nervous system abnormalities. Raised intracranial pressure - isotretinoin must not be combined with tetracyclines 23 or vitamin A. Mood disturbance, depression, inability to concentrate and study - this is controversial as large studies do not show an increase in depression and suicide ideation in isotretinoin users.

The British Association of Dermatologists recently reviewed psychiatric side-effects. Musculoskeletal abnormalities. CK-levels may become markedly raised. Decreased bone density does not occur in young people taking regular dosages of isotretinoin, 27 but it has been demonstrated where vitamin D deficiency co-existed.

This has not been studied, probably because the rest of the world does not follow this practice. No data exist on bone density in year-old patients who had previously taken low dosages of isotretinoin for 5 years. Diffuse idiopathic skeletal hyperostosis DISH can occur at higher dosages used for prolonged periods.

The spinal ligaments are particularly prone to this complication. No data exist on this effect when low dosages are used for long periods. Premature closure of epiphyses is possible. Gastro-intestinal side-effects.

Ulcerative colitis is controversial; some studies 31 found that isotretinoin can cause ulcerative colitis, while others 32 deny it. The possible association of ulcerative colitis with isotretinoin, resulting in court cases, is a reason for an ethical company withdrawing their isotretinoin from the market in the USA.

The GA states that acne is cured when, after treatment is discontinued, no further treatment is required. A cure has been achieved if a recurrence is so mild that the patient does not deem treatment necessary. Problems in interpreting the literature mostly arise here. Differing definitions of a cure result in confusing conclusions from studies and the long-term effects of oral isotretinoin, e. This is no cure by any standard and created a false impression of the results.

The pitfalls of inappropriate use of oral isotretinoin. The pitfalls are largely medicolegal. The oral drug is slightly more effective, but topical retinoids have minimal risk and are therefore the maintenance drug of choice. A hypothetical malpractice court case where a prescribing physician is litigated against for the trauma of any of the complications listed, would be indefensible if the indications and dosing did not match the accepted, published guidelines at the time.

Lawyers would use evidence from the literature and any doubts will be applied in favour of the complainant. That such action would not hold up in court means that the patient's best interests are not taken into account when using oral isotretinoin inappropriately.

The fact that the patients often request, or force, doctors to prescribe it, does not relieve the responsibility to do the evidence-based correct thing. Why some dermatologists use isotretinoin in inappropriate dosing regimens and for the wrong indications. Patient pressure forcing doctors to comply to protect their client base.

Teenage patients prefer to swallow a tablet to applying a daily messy cream. The drying effect of topical retinoids, although less than that of systemic retinoids, is often an excuse to use the systemic drug instead.

Many healthcare professionals are not aware of the published guidelines, especially those on topical retinoids and their excellent efficacy.

Laziness, convenience. It is less effort to prescribe low-dose systemic isotretinoin, with few obvious side-effects, than a complicated topical retinoid, for which the patient must be educated, and continually motivated to use it. Complacency about possible litigation. The 'I know best' attitude is rife in South Africa. Why we must adhere to accepted global guidelines on the use of systemic isotretinoin.

The main reason is to protect patients against the drug's adverse effects. Some are potentially serious and the more the drug is used, the more likely these events will be encountered. Healthcare professionals must be protected against litigation for possible negligence when not prescribing the drug according to the guidelines and adverse events occur.

Patients who 'force' the doctor to prescribe the drug are often the first to litigate if something goes wrong. We cannot risk losing access to the drug, one of dermatology's most valuable assets, as a result of inappropriate use. The European restrictions prevent some deserving patients from accessing this drug. The American Gynecological Society lobbied for its ban for years, and such actions should not be given more ammunition through our carelessness.

Recommendations on the rational use of systemic isotretinoin. Lower than standard doses of oral isotretinoin should only be prescribed in exceptional cases, after all safer alternatives have been considered and used but failed, or were impractical to use.

It should never be used as primary therapy for moderate degrees of acne. We should follow the world-wide accepted guidelines for which there are very good reasons. Conflict of interest. The author is a member of the Global Alliance for the Improvement of Outcomes in Acne Vulgaris, sponsored in full through an unlimited educational grant from Galderma.

This paper has been endorsed by the academic heads of dermatology in South Africa. Isotretinoin for acne vulgaris - 10 years later: a safe and successful treatment. Br J Dermatol ; 3 Low dose isotretinoin combined with tretinoin is effective to correct abnormalities of acne.

J Dtsch Dermatol Ges ;2 1 Effectiveness of conventional, low-dose and intermittent oral isotretinoin in the treatment of acne: a randomized, controlled comparative study.

Br J Dermatol ; 6 Schwartz S. Low dose isotretinoin - what does the literature say? SA Dermatology Review ;11 2 Sinclair W, Jordaan HF. Acne Guidelines update. S Afr Med J ; Management of acne: a report from a global alliance to improve outcomes in acne. J Am Acad Dermatol ;49 1 :S J Am Acad Dermatol ;S A review of the European Directive for prescribing systemic isotretinoin for acne vulgaris. J Eur Acad Dermatol ; Layton A. The use of isotretinoin in acne. Dermatoendocrinology ;1 3 Vallance P.

Drugs and the fetus. BMJ ; Low levels of alitretinoin in seminal fluids after repeated oral doses in healthy men. Clin Exp Dermatol ;36 s2 Treatment of acne with intermittent isotretinoin. Br J Dermatol ; Ganceviciene R, Zouboulis CC. Isotretinoin: state of the art treatment for acne vulgaris. Exp Rev Dermatol ; Isotretinoin and pregnancy. J Am Acad Dermatol ;10 5 Pt 1 Kuenzli S, Saurat J-H.

Dermatology Volume 2. London: Mosby, Minor malformations characteristic of the retinoic acid embryopathy and other birth outcomes in children of women exposed to topical tretinoin during early pregnancy. Am J Med Genet ; 2 Periungual and subungual pyogenic granuloma. Br J Dermatol ; 5 Zachariae H. Delayed wound healing and keloid formation following argon laser treatment or dermabrasion during isotretinoin treatment.

Conclusion: Low back pain is one of the most common musculoskeletal side effects of isotretinoin treatment that usually resolves with dose reduction. The cumulative dose of isotretinoin does not seem to play a role in the development of back pain, but can determine pain severity.

Pain severity is directly correlated with the increasing age. Evaluation of the patients for musculoskeletal side effects during isotretinoin use is important in clinical practice, as it is a common occurrence. Evaluation of musculoskeletal adverse effects in patients on systemic isotretinoin treatment: A cross-sectional study. Arch Rheumatol ;37 2 The study was conducted in accordance with the principles of the Declaration of Helsinki.

A written informed consent was obtained from each patient. Data Sharing Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request. Design, draft of manuscript: E.

Keywords: Acne, hyperostosis, inflammatory back pain, sacroiliitis, spondyloarthropathy, systemic isotretinoin. Objectives: This study aims to investigate the frequency of musculoskeletal adverse effects in acne vulgaris patients receiving systemic isotretinoin treatment.

Patients and methods: Between January and Decembera total of severe acne patients 22 males, females; mean age: Data including age, sex, body mass index BMIduration of disease, diagnosis, and comorbidities were recorded.

Results: The treatment period was mean 8. The dose of isotretinoin was mean 0. Musculoskeletal side effects were seen in 99 Back pain was reported during the treatment period in 78 The diagnosis was mechanical back pain in 31 Creatine kinase elevation was reported in 18 Conclusion: Low back pain is one of the most common musculoskeletal side effects of isotretinoin treatment that usually resolves with dose reduction.

The cumulative dose of isotretinoin does not seem to play a role in the development of back pain, but can determine pain severity. Pain severity is directly correlated with the increasing age. Evaluation of the patients for musculoskeletal side effects during isotretinoin use is important in clinical practice, as it is a common occurrence.

Evaluation of musculoskeletal adverse effects in patients on systemic isotretinoin treatment: A cross-sectional study. Arch Rheumatol ;37 2 The study was conducted in accordance with the principles of the Declaration of Helsinki. A written informed consent was obtained from each patient. Data Sharing Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Design, draft of manuscript: E.

Systemic isotretinoin has been used to treat severe acne vulgaris for 20 years. However, isotretinoin also represents a potentially useful choice of drugs. Systemic isotretinoin remains the most efficacious treatment for severe acne as well as many cases of more moderate disease that are unresponsive to other. Systemic isotretinoin therapy normalizes exaggerated TLRmediated innate immune responses in acne patients. J Invest Dermatol ; Systemic isotretinoin remains the most efficacious treatment for severe acne as well as many cases of more moderate disease that are unresponsive to other. Early and appropriate therapy allows better management of the disease, longer remission, scars risk reduction, and improvement of quality of. A cure has been achieved if a recurrence is so mild that the patient does not deem treatment necessary. Diseases such as psoriasis, pityriasis rubra pilaris, condylomata acuminata, skin cancers, rosacea, hidradenitis suppurativa, granuloma annulare, lupus erythematosus and lichen planus have been shown to respond to the immunomodulatory, anti-inflammatory and antitumor activities of the drug. Alonso PW. Bernestein LJ, Geronemus R. Vallance P. The British Association of Dermatologists recently reviewed psychiatric side-effects.

The rational use of systemic isotretinoin in acne: A call for moderation. Corresponding author. Systemic isotretinoin effectively treats all forms of acne vulgaris.

However, it has many side-effects, some potentially serious, that warrant limiting its use to serious cases of acne. Inappropriate use in large numbers of patients puts prescribers at risk of malpractice litigation should serious side-effects occur where safer alternative treatments were available. Doctors also risk losing access to the drug should authorities limit its use to reduce the occurrence of side-effects. Systemic isotretinoin can be considered to be a 'wonder drug' that has revolutionised the treatment of acne vulgaris, massively improving outcomes in nodulocystic acne.

It is highly effective in all forms and grades of acne vulgaris, even in lower dosages 2,3 though lower dosages rarely cure even minor degrees of the disease. To a lesser degree, lower dosages usually effectively clear the skin, but this is merely symptomatic and may be required indefinitely to maintain the response and prevent relapse.

In South Africa, there is a massive trend towards the universal use of lower dosages of systemic isotretinoin for lesser degrees of acne vulgaris and it is prescribed by dermatologists and general practitioners alike.

This custom is propagated by dermatologists in lectures and literature to general practitioners. Most countries subscribe and contribute to the Global Alliance for the Improvement of Outcomes in the Treatment of Acne Vulgaris GA who analyse all literature concerning acne and provide guidelines for its treatment.

These were accepted by all dermatologists in South Africa and published in Global guidelines on the use of systemic isotretinoin. The GA and South African official indications for the use of isotretinoin are: However, in Europe there are severe restrictions on the use of isotretinoin, as follows: 7 Systemic isotretinoin may not be used as first line of treatment for any grade of acne. For any form of acne, isotretinoin may only be prescribed after failure of a 3-month course of systemic antibiotics combined with topical treatment retinoids or benzoyl peroxide.

It may not be prescribed for acne in children under the age of 12 years. The minimum starting dose is 0. General practitioners may not initiate isotretinoin treatment. The pregnancy prevention programme PPP dictates that monthly pregnancy tests in females should be performed before, during and up to 5 weeks after completion of a course of isotretinoin. A supply of only 30 days of isotretinoin may be dispensed at one time and prescriptions are valid for only 7 days.

Treatment may only start on the third day of a normal menstrual period. Where possible, patients should agree to at least one and preferably two complementary methods of effective contraception including a barrier method before initiating therapy. The clinician has the responsibility for assessing pregnancy tests before further prescriptions. Not all experts agree on these harsh directives 8 and feel that in severe cases, systemic isotretinoin should be used earlier to limit the psychological impact of the disease and scarring.

Similar restrictions apply in the USA concerning pregnancy prevention. All patients, male and female, must enrol in the iPledge programme, a national registry, failing which the patient would not receive the drug.

Women of childbearing age must provide two negative pregnancy tests before their initial prescription, show proof of another negative pregnancy test before each monthly repeat prescription, and use two forms of contraception that must be entered into the registry throughout therapy and for 30 days after treatment.

All patients sign confirmation that they are aware of potential adverse effects including depression and suicidal thoughts. These severe restrictive and controlling measures in Europe and the USA apply to all users of the drug, regardless of the dosage. The accepted standard dosage of a full course of treatment is 0.

These guidelines do not include low-dose oral isotretinoin in the management of acne, but the South African publication of allows for pulse therapy in recurrent acne after a full course of oral isotretinoin and if topical retinoids failed to prevent relapse or are impractical to use e. Isotretinoin is then used at a maximum of 0.

Except for the pulse dosages, no guideline recommends long-term dosages below 0. None recommends systemic isotretinoin as first line for acne of moderate degree i. What is 'low-dose' systemic isotretinoin? There is no consensus on what constitutes low-dose oral isotretinoin. European and American literature seem to regard a dose below 0. Although these regimens are effective in controlling mild acne, 2 using it as maintenance treatment mostly falls outside the accepted guidelines.

The global guidelines on maintenance treatment for acne vulgaris. The only drugs recommended for maintenance treatment of acne, after initial clearance, are topical retinoids and hormonal treatment in females, which may be combined. Oral isotretinoin is not mentioned as an option but the South African guidelines allow for pulse therapy in selected cases. Two papers on the use of oral isotretinoin give excellent guidance on this issue, including its side-effects.

Adverse side-effects of systemic isotretinoin. Some pertinent or controversial points are dealt with here. Topical retinoids seem to have no teratogenic effect when used in pregnancy, 16 but have not been cleared for use in pregnant women.

Mucocutaneous side-effects. Initial worsening of acne; xerosis and cheilitis; retinoid dermatitis; epistaxis; staphylococcal infections of the skin, often of the nail folds, to cause paronychia; 13 pyogenic granulomas of the nail folds are often seen on the toes; 17 hypertrophic scarring and keloids - dermabrasion should be delayed after isotretinoin because severe hypertrophic scarring may result; 18,19 hypertrophic scarring has been reported when isotretinoin was administered 2 months after dermabrasion 20 and also spontaneously, without prior surgery, on isotretinoin therapy.

Ocular complications. Dry eyes that can persist indefinitely; 22 blepharoconjunctivitis; keratitis with corneal ulceration is rare; 13 recent use of isotretinoin is a contraindication to laser refractive eye surgery; decreased night vision is a common and potentially dangerous side-effect, making driving a vehicle at night hazardous and is the reason why aviation pilots may not use the drug.

Night blindness can persist indefinitely. Laboratory abnormalities. Liver enzyme disturbance; raised serum lipids especially triglycerides. Central nervous system abnormalities. Raised intracranial pressure - isotretinoin must not be combined with tetracyclines 23 or vitamin A. Mood disturbance, depression, inability to concentrate and study - this is controversial as large studies do not show an increase in depression and suicide ideation in isotretinoin users.

The British Association of Dermatologists recently reviewed psychiatric side-effects. Musculoskeletal abnormalities. CK-levels may become markedly raised. Decreased bone density does not occur in young people taking regular dosages of isotretinoin, 27 but it has been demonstrated where vitamin D deficiency co-existed.

This has not been studied, probably because the rest of the world does not follow this practice. No data exist on bone density in year-old patients who had previously taken low dosages of isotretinoin for 5 years.

Diffuse idiopathic skeletal hyperostosis DISH can occur at higher dosages used for prolonged periods. The spinal ligaments are particularly prone to this complication.

No data exist on this effect when low dosages are used for long periods. Premature closure of epiphyses is possible. Gastro-intestinal side-effects. Ulcerative colitis is controversial; some studies 31 found that isotretinoin can cause ulcerative colitis, while others 32 deny it. The possible association of ulcerative colitis with isotretinoin, resulting in court cases, is a reason for an ethical company withdrawing their isotretinoin from the market in the USA.

The GA states that acne is cured when, after treatment is discontinued, no further treatment is required. A cure has been achieved if a recurrence is so mild that the patient does not deem treatment necessary. Problems in interpreting the literature mostly arise here. Differing definitions of a cure result in confusing conclusions from studies and the long-term effects of oral isotretinoin, e. This is no cure by any standard and created a false impression of the results.

The pitfalls of inappropriate use of oral isotretinoin. The pitfalls are largely medicolegal. The oral drug is slightly more effective, but topical retinoids have minimal risk and are therefore the maintenance drug of choice. A hypothetical malpractice court case where a prescribing physician is litigated against for the trauma of any of the complications listed, would be indefensible if the indications and dosing did not match the accepted, published guidelines at the time.

Lawyers would use evidence from the literature and any doubts will be applied in favour of the complainant. That such action would not hold up in court means that the patient's best interests are not taken into account when using oral isotretinoin inappropriately.

The fact that the patients often request, or force, doctors to prescribe it, does not relieve the responsibility to do the evidence-based correct thing. Why some dermatologists use isotretinoin in inappropriate dosing regimens and for the wrong indications.

Patient pressure forcing doctors to comply to protect their client base. Teenage patients prefer to swallow a tablet to applying a daily messy cream. The drying effect of topical retinoids, although less than that of systemic retinoids, is often an excuse to use the systemic drug instead. Many healthcare professionals are not aware of the published guidelines, especially those on topical retinoids and their excellent efficacy.

Laziness, convenience. It is less effort to prescribe low-dose systemic isotretinoin, with few obvious side-effects, than a complicated topical retinoid, for which the patient must be educated, and continually motivated to use it. Complacency about possible litigation. The 'I know best' attitude is rife in South Africa.

Why we must adhere to accepted global guidelines on the use of systemic isotretinoin. The main reason is to protect patients against the drug's adverse effects. Some are potentially serious and the more the drug is used, the more likely these events will be encountered. Healthcare professionals must be protected against litigation for possible negligence when not prescribing the drug according to the guidelines and adverse events occur. Patients who 'force' the doctor to prescribe the drug are often the first to litigate if something goes wrong.

We cannot risk losing access to the drug, one of dermatology's most valuable assets, as a result of inappropriate use. The European restrictions prevent some deserving patients from accessing this drug. The American Gynecological Society lobbied for its ban for years, and such actions should not be given more ammunition through our carelessness.



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