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For many years now, British and American dermatologists and cosmetic practitioners have been using isotretinoin, commonly known by the brand names Roaccutane® / Accutane®, (depending on which side of the pond you’re on) to treat severe cases of acne. Yet controversies are abound linking it to serious bowel diseases.
This prescription-only drug made by the pharmaceutical giant Roche is taken in tablet form and contains a derivative of Vitamin A. Isotretinoin (pronounced EYE so TRET i noyn) acts by reducing the amount of oil released by sebaceous glands in the skin, (which can contribute to clogged pores and which acne-causing bacteria propionibacterium acnes (p.acnes) like to feed on); as well as a reducing the size of the pores, it also helps the skin to renew itself more quickly and reduces the overproduction of keratin which can also clog up pores.
Faced with lawsuits and accusations in relation to the drug, along with what it claimed was growing competition, Roche withdrew Accutane® from U.S. sale in June 2009 after almost three decades of use, yet many generic isotretinoin products are still produced and widely available, sold under the names Claravis, Sotret and Amnesteem. Roaccutane® (and a generic isotretinoin product) is still available on prescription in the U.K.
Due to its potency, isotretinoin has traditionally been used as a ‘last chance saloon’ treatment for severe acne sufferers who have failed to respond, often for many years, to conventional treatments using topical medications (e.g., benzoyl peroxide, adapalene etc.) and oral antibiotics. Severe forms of acne are those such as nodular or conglobate acne or acne at risk of permanent scarring. However, there is now a tendency to use it in a lower daily dose, and also use it in less severe cases of acne, as isotretinoin is the only acne medication that switches off acne for good in the majority of patients.
Isotretinoin is known to have the potential for side effects, such as causing severe birth defects if taken when pregnant plus the risk of liver disease and adverse psychiatric effects such as depression, as well as other more minor side effects related to its ‘drying’ action such as chapped lips, dry skin and itching, irritation of the eyes and eyelids and joint and muscle pain to name the most common. However, apart from side effects related to skin drying, isotretinoin is tolerated well in the majority of patients. Also, it is considered by many to still be safer than the long-term use of antibiotics as most of these side effects are easily counteracted by emollients and the like to rehydrate the areas affected by dryness and with the use of birth control in women of childbearing age to avoid pregnancy during use of the drug.
Some patients however have long held the belief that they have suffered additional side effects from taking the drug which relate to gastro-intestinal problems sometimes manifesting a long time after taking the medication.
Some earlier studies have also shown this to be apparently true. This has led to approximately 5,000 private personal injury claims and class action lawsuits being compiled against Roche in the USA and beyond.
In one case a woman diagnosed with ulcerative colitis (a form of inflammatory bowel disease) received $10.5 million for pain and suffering in a legal action filed against Roche. She was also awarded $78,500 for medical expenses after her legal team proved that the company knew of a potential risk of inflammatory bowel disease but failed to report it to the American Food and Drug Administration (FDA).
Now, however, a new study has emerged, published this month in the American Journal of Gastroenterology which the wider press is again proclaiming proves that the drug can, in a very small number of cases, cause inflammatory bowel disease as suspected by many. The study was led by Dr. David Margolis, a U.S. dermatologist from the University of Pennsylvania. Yet, if you delve a bit deeper into the study and its authors it shows a different story to that which the sensational headlines would have us believe – maybe it’s not all isotretinoin’s fault after all.
Dr. Margolis was originally asked by lawyers representing a company making a generic isotretinoin competitor product for assistance in a legal case against them. He, along with his research team undertook a study based on the fact that many patients undergo extensive treatment with antibiotics prior to eventually taking isotretinoin. With this fact in mind he wanted to explore whether or not these antibiotics may also contribute to the risk of developing gastrointestinal problems or whether the isotretinoin could be solely to blame.
During the study they examined the medical history of more than 94,000 teenagers and young adults in the United Kingdom who were diagnosed with acne over a period of 8 years from 1998 onwards.
The results showed that the patients who underwent extensive treatment with antibiotics were twice as likely to develop inflammatory bowel disease as other patients who did not, with those taking a drug from the tetracycline family known as doxycycline showing the greatest increased risk of developing the disease.
This increased risk was found to be particularly associated with one form of inflammatory bowel disease called Crohn’s Disease. Like the other form of the disease, ulcerative colitis, it leads to severe diarrhoea and abdominal pain, with many patients eventually needing surgery for the removal of parts of their intestines.
So on the face of it, you could argue it’s more likely that a history of antibiotic use is to blame if someone develops inflammatory bowel disease and not isotretinoin, yet Dr. Margolis said that the drug was not necessarily free of blame when he was interviewed by Reuters Health, but did point to the fact that other previous drug programmes, including antibiotics, needed to be considered as contributory factors in cases of inflammatory bowel disease in acne patients.
"I'm not sure if isotretinoin is on or off the hook all by itself," he said. "I think this research indicates that in a careful study one should probably consider antibiotic use as well,” he added.
Dr. Stefanie Williams, a London based Dermatologist (www.eudelo.com) says; “I have prescribed oral isotretinoin to many, many patients over the years and the vast majority of patients tolerate the medication very well, apart from common dryness-related side effects such as chapped lips.
However, I now tend to prescribe it in much lower doses compared to what we used to do. This might prolong the overall course slightly but tends to be much better tolerated. The treatment results with isotretinoin can be truly amazing and it certainly remains the best acne medication we have to date. Acne is a very distressing condition that can be disfiguring in some patients and may result in permanent scarring. Research has shown that even non-severe acne can cause profound emotional problems such as depression and even suicidal thoughts. Acne has also a significant impact on the patient’s quality of life and personally, I have seen many patients who were absolutely delighted with their isotretinoin results. I have had patients telling me that the treatment has literally changed their life and that they now feel much more confident and happy within themselves, and also have a much more satisfying social life.
I would always strongly encourage anybody suffering from breakouts or acne to have this treated and your dermatologist will be able to decide whether you might be a candidate for isotretinoin.”
Do you have any experience with isotretinoin use for acne? Are you a patient or a practitioner? Please share your anecdotal evidence, you can even do it anonymously if you’d prefer.
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