Roaccutan 20mg/10mg (or Roaccutane ) belongs to the family of Vitamin A derivative-medications which are prescribed for the treatment of severe acne in patients. Roaccutan contains Isotretinoin (a retinoid) which acts systemically for the elimination of acne in patients. This drug, Roaccutan is actually another version of Accutane, which is one of the largely known brands for the management of severe acne in patients. Although highly effective, Isotretinoin products are linked to a number of adverse side effects which includes teratogenicity. Today, Accutane is already discontinued by the manufacturer, although there was no formal recall of the product . Although Accutane is gone, there are still numerous versions of the Isotretinoin drug found in the market as Isotretinoin products like it are still used in the management of acne though they are known to cause a number of side-effects in patients.
There are a number of manufacturers for Roaccutan like Roche, Investi, and Uhlmann-Eyraud Pharma. These manufacturers make a number of Isotretinoin-containing products bearing the brand Roaccutan. Aside from the gel capsules, Roaccutan is also manufactured in tablet form, and topical gel and crème forms.
Information on Roche Pharmaceuticals
One of the manufacturers of Roaccutan in Roche, which is a world leader when it comes to pharmaceutical manufacturing. The company dates its roots back to 1896, in Basel, Switzerland . Roche is considered to be one of the pioneers in the field of healthcare and it continues to lead in the fields of pharmaceutical manufacturing, biotechnology, and diagnostics . Currently, the company is on the number 1 spot for biotechnology and remains to be the leader in developing cures for oncology .
The company operates on a massive scale, as Roche has a workforce of about 90,000 employees in some 100 nations . It is also invested in research and development and it spends millions in the said field, for the improvement of existing formulations and the development of new treatments and diagnostic tools for the benefit of the people .
There is no question in the level of quality employed by the company with regards to the manufacture, distribution, and the development of its products. Roche is a well-accredited and well-certified company with numerous approvals from the US FDA and similar agencies worldwide. Roche also has a number of US FDA accreditations for its specific products, like its Accutane for acne (also known as Roaccutane/Roaccutan worldwide) , which is only one of the US FDA approved products for the company.
The most recent of Roche’s achievements in US FDA approvals are the Breakthrough Therapy Designation for its multiple sclerosis medication Ocrelizumab , advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) medication Alcensa or alectinib , and its TECENTRIQ (atezolizumab) for metastatic lung cancer . Aside from these achievements, Roche pushes a number of products for US FDA approvals and is looking forward to more US FDA-accredited medications.
Scientific Studies on Isotretinoin
Isotretinoin, in the past years, has acquired numerous researches for its effectiveness in its application as an acne treatment. Aside from the study on the active ingredient itself, there were also studies specific to certain brands of Isotretinoin products like Accutane and Roaccutane/Roaccutan for their effects on patients. One of the studies on these product brands is from Mahrle et al in 1985, “[Roaccutan in acne and rosacea]” . The study presented the use and effectiveness of the then recently approved drug, Roaccutan (Accutane) in the management of acne and rosacea in patients . According to the study, Isotretinoin products like Roaccutan is used for treatment-resistant, severe cystic acne, and the drug works primarily by decreasing sebaceous gland size and by reducing the bacterial presence in the patients . The effect of Roaccutane, when administered in doses of 0.5 mg to 1 mg per kg of body weight daily, is the visible clearing of the acne eruptions and long-term remission even after the end of therapy . 18 Rosacea patients were also treated with Accutane/Roaccutan and the results were also good . According to the authors, the drug caused some side effects in the patients, but the side effects did not lead to the discontinuation of treatment . Since during the period, Roaccutan treatment (Isotretinoin) was newly introduced, the authors concluded that Isotretinoin treatment offers a new perspective in the treatment of non-responsive acne types in patients .
Since acne is not only a physiological disease and is known to be beneficial even on the psychological aspects of patients, Isotretinoin treatments like Roaccutane/Roaccutan were also observed for their effect on the patients’ quality of life post or during treatment. The study “The effect of isotretinoin (roaccutane) therapy on depression and quality of life of patients with severe acne” by Fakour et al in 2014 is one of the studies which aimed to determine the link of Isotretinoin treatments with the patients’ psychosocial development . In this study, 98 patients with severe acne were subjected to Isotretinoin (Roaccutane) treatment of 0.5 mg/kg/day for a period of 16 weeks . Using DLQI (Dermatology Life Quality Index) and the BDI (Beck Depression Inventory) questionnaires, the patients were evaluated for the drug’s effect on the patients’ quality of life and depression . Although the patients showed improvement in their quality of life as per DLQI evaluation, the patients exhibited increased scores on their BDI results, implying that the drug caused depression to some extent . This study is one of those which showed that Isotretinoin products may be the cause of depression in patients undergoing Isotretinoin therapy for severe acne .
Along with the popularity of Accutane/Roaccutane/Roaccutan in the market is also the rise of a large number of generic counterparts for the Isotretinoin medication. Since this is the case, there is a question regarding the purity of these generic medications and if they are at par with the US FDA-approved brand for Isotretinoin. Taylor and Keenan in 2006 in their study, “Pharmaceutical quality of generic isotretinoin products, compared with Roaccutane” studied the pharmaceutical quality of some 14 generic Isotretinoin medications in comparison with the branded Roaccutane . It is interesting that the 14 generic Isotretinoin products showed a 30-fold difference in their median particle size and showed differences in their ingredients which were non-active . According to the results, Acnotin and Acne-Tretin did not fall within 95-105% of Roche specifications . Only 4 of the 14 medications were able to retain their shelf-life during shelf-life tests,2 exceeded the +/-2% (Ph.Eur.) and 3 exceeded the +/-1% (USP) for their tretinoin contents, 8 of the products exceeded the impurity specification, and 6 of the products were discovered to have unknown impurities (> or =5) . These results showed that although generic medications contain the same active ingredients, they failed to match the standard medication (Roaccutane) . Based on the results, the authors concluded that not all of the Isotretinoin products are the same with or as effective or safe as the US FDA-approved acne medication .
Description and Mechanism of Action of Isotretinoin
Medications containing Isotretinoin are proven to cause the skin to clear up even in patients with grave acne conditions. This effect of Isotretinoin can be attributed to its action on the sebaceous cells, as it is observed to cause cell apoptosis and eventually cause the shrinkage of the sebaceous glands.
Due to this action, the sebum production on the skin is limited and the sebum overproduction ceases. The hyperactivity of the sebaceous glands is the culprit to the blockage of pores and follicles which eventually leads to the formation of acne lesions in the skin. The condition is exacerbated by the presence of the bacteria P.acnes, which metabolizes sebum and produces excreta which trigger the inflammatory response in the skin.
Since Isotretinoin regulates the sebum in the skin, the bacterial population of in the skin also decreases, which leads to the lessening of the inflammation in the skin. Since there is also less sebum, the formation of new lesions and comedones are lessened, which prompts in the eventual skin clearing in severe acne patients.
Roaccutan Benefits for Acne and Scars
One of the visible benefits of Isotretinoin products for acne is the clearing of the skin and the healing of the acne lesions as a consequence of the drug’s inhibition of the sebum production. The before and after effects of Isotretinoin for acne can be observed a few weeks into treatment, although it includes some side effects like drying of the skin especially in the lips, nose, mouth, and the eyes.
Patients are treated with Isotretinoin products when the first options for the treatment for acne fail, so it can be said that Isotretinoin is highly effective in the treatment of acne in patients who were administered the drug. It is also interesting that Isotretinoin also has other applications in the dermatological practice, as the topical Isotretinoin (and at times, the oral form too) is used for the restoration of aging skin cells. Isotretinoin products are used to improve wrinkles, and even various scars (keloids, etc.) and stretch marks.
Isotretinoin in skin aging is also well tolerated, and in some studies, it is also discovered to be tolerated better than patients treated with Tretinoin. Its effects are also more pronounced when it comes to anti-aging treatment, although there’s still a long way to go for the product’s formal induction as an established treatment for photoaging.
Recommended Doses and Duration of Therapy
Early studies  regarding Isotretinoin use mention that the initial dose of the product is 0.5 mg to 1 mg per kg in a day for patients diagnosed with severe acne. The usual length of treatment is 16 weeks or until the skin condition improves. There is much variation when it comes to the dosage recommendations for Isotretinoin use, as there are different preferences by dermatologists regarding its administration.
Some studies lean towards the increased dosing depending on the acne severity, while others recommend long-term but low-dose treatments. But the best treatment practices are the ones which are sensitive to the patients’ needs and response to treatment; Isotretinoin dose should be dependent upon the reaction of the patients to the initial dosage during the early weeks of treatment. If the patients experience intolerable side effects, then the dosage should be lessened, as the side effects of the drug are always dose-related.
Side effects and Warnings
There are a number of side effects related to the use of Isotretinoin products like Roaccutan in patients. Tolerable side effects are observed like the drying of the skin and the mucosa, but there are also more serious implications of the use of Isotretinoin in patients.
The major and the most controversial of the side effects of Isotretinoin is its teratogenicity. Its effect on the fetal formation is quite pronounced, and Isotretinoin use is linked to pregnancy termination and fetal malformations on pregnant mothers under Isotretinoin treatment. Aside from its teratogenicity, serious side effects are also evident like bowel diseases (Crohn’s disease), damage to the liver, depression, and a number of other systemic side effects .
Since Isotretinoin use leads to a number of undesired effects in patients, its use should just be under strict supervision of the medical professionals. There are also a lot of tests before patients are allowed to take Isotretinoin, as there are numerous considerations to make to ensure that the intake of the drug is safe for the patients. Because taking Isotretinoin is a sensitive issue, patients should listen and follow their dermatologists’ instructions well, to avoid untoward incidences related to Isotretinoin use.
Isotretinoin interacts with a number of drugs and there are about 92 drug interactions determined for Isotretinoin, which is a total of 788 brand and generic drug interactions . Alcohol also reacts with the drug, so patients should not take alcohol and alcohol-containing medication as Isotretinoin reacts with alcohol too. The drugs commonly interacting with Isotretinoin are vitamin A medications, multivitamins, vitamin D3, pain relievers like ibuprofen, amphetamines, tetracyclines, antidepressants, and a number of others .
Aside from these meds, the patients should also take contraceptives with care, as progesterone weakens the effect of Isotretinoin in patients. Also, in addition to the mentioned medications, the patients should take herbal medications with care as these meds are also known to interact with Isotretinoin and influence its effectiveness in the patients. To be safe, patients should always consult with their doctors regarding the meds they are planning to add to their Isotretinoin treatment to avoid adverse drug interactions and prevent harm.
Reviews are available for the product Roaccutan/Roaccutane/Accutane from patients who were given the drug for the treatment of their acne cases. There are patients asking a number of inquiries regarding the side effects of the drug, as seen in one of the forums for acne patients (see image below).
One user asked whether Accutane use causes side effects in patients and even went on to ask if Accutane can make the skin lighten. The user’s query is answered by a Las Vegas dermatologist and the doctor said that Accutane use causes side effects, like any other drug. But he made it clear that Accutane does not make the patients’ skins lighten. According to the doctor, the side effect of the acne medication is relative to the amount of the dose prescribed, so he usually prescribes low doses of Isotretinoin (Accutane) to his patients to lessen the intensity of the side effects.
Price, Available Forms and Dosage
Although the product Accutane is discontinued and recalled in the US, the product is still available in some online stores as Roaccutan/Roaccutane. There are vendors like Sport-pharma.net which still has the product available. The store has the 10 mg variant and the 30-tablet pack costs $41.85. The price is good, but the store is selling the product for less when the quantity bought is increased.
Other vendors also have the product available for international shipping, which is actually beneficial for some international clients. Like all other internet pharmacies, a number of stores have flat shipping rates regardless of the destination country of the deliveries. Mcsteroids.am charges $15.69 for shipping to all the destination countries.
Although Accutane/Roaccutan has been recalled in the USA, vendors like Mcsteroids.am are still able to ship the product to the USA and other countries like Canada and Australia. The rate for shipping the product is good too, as the patients only have to pay a flat rate of roughly $16 for the shipment. The fact that Roaccutan is available for international shipping makes it advantageous over other brands as a lot of Isotretinoin brands are not available for international consumption.
Conclusion and Rating
Although there are a number of issues surrounding the use of Roaccutan or Accutane for the treatment of severe acne, I think the product still deserves a perfect score of 5 out of 5. Based on the mentioned studies, the generic counterparts for the medication are not within close range of the product’s quality and effectiveness, as most of them are impure and have failed a number of tests regarding their contents. The product’s high quality can be accounted to the high-quality manufacturing of the well-awarded and accredited Roche pharmaceuticals.
There are many issues regarding the adverse effects of Isotretinoin (Roaccutan) in patients, but the appearance of the side effects all boils down to the prescription of the dose by the physicians. Regarding teratogenicity, the patients are asked to join specific programs to help them prevent conception while on Isotretinoin treatment and prevent the incidence of adverse effects on the unborn fetus.
In the end, the patients are the one to decide whether they are to push through with their Isotretinoin treatment, as they are the ones who will deal with the side effects of the drug later on in treatment. Roaccutan as an Isotretinoin treatment remains to be an effective agent in the cure of severe acne, so it is still widely prescribed by doctors and used by patients until today.
- Acnespecialisten.se: What is Roaccutane. Available from: http://www.acnespecialisten.se/roaccutan.php
- Drugwatch.com: Accutane Recall. Available from: https://www.drugwatch.com/accutane/recall.php
- Roche.com: Our history. Available from: http://www.roche.com/about/history.htm
- Roche.com: About Roche. Available from: http://www.roche.com/about.htm
- Roche.com: Diversity & Inclusion. Available from: http://www.roche.com/sustainability/what_we_do/for_employees/diversity.htm
- Accessdata.fda.gov: [email protected] FDA Approved Drug Products. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=isotretinoin&SearchType=BasicSearch
- Roche.com: Investor Update. Available from: http://www.roche.com/investors/updates/inv-update-2016-02-17.htmv
- Roche.com: Media Release. Available from: http://www.roche.com/media/store/releases/med-cor-2016-10-04.htm
- Roche.com: Media Release. Available from: http://www.roche.com/media/store/releases/med-cor-2016-10-19.htm
- Mahrle G, Bauermeister-Jasso K, Enderer K. [Roaccutan in acne and rosacea]. Zeitschrift fur Hautkrankheiten. 1985 Jan;60(1-2):120-5. Available from: https://www.ncbi.nlm.nih.gov/pubmed/3157273
- Fakour Y, Noormohammadpour P, Ameri H, Ehsani AH, Mokhtari L, Khosrovanmehr N. The effect of isotretinoin (roaccutane) therapy on depression and quality of life of patients with severe acne. Iranian journal of psychiatry. 2014 Oct;9(4):237. Available from: https://www.ncbi.nlm.nih.gov/pubmed/25792992
- Taylor PW, Keenan MH. Pharmaceutical quality of generic isotretinoin products, compared with Roaccutane. Current medical research and opinion. 2006 Mar 1;22(3):603-15. Available from: https://www.ncbi.nlm.nih.gov/pubmed/16574043
- Drugs.com: Accutane (isotretinoin) Drug Interactions. Available from: https://www.drugs.com/drug-interactions/isotretinoin,accutane.html