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Isotretinoin for Rosacea

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    What you should know about Accutane (isotretinoin). This article is frequently updated as new information is discovered [updated 4/29/2020]

Accutane (Isotretinoin) has been used for many years to treat acne rosacea in higher doses so if you are taking high dose Accutane (20-40 mg or higher) you should read below as well as the list of anecdotal reports causing Accutane induced rosacea. If you are taking low dose Accutane (isotretinoin) 2.5 - 10 mg read this post, it would be pertinent for you to read below as well.  

"Severity of symptoms varies but may result in facial scarring and psychological repercussions. Oral isotretinoin is highly effective but can only be prescribed by specialists. Side effects are recognized and mostly predictable, ranging from cosmetic effects to teratogenicity. These can affect patients' quality of life and treatment adherence." Source

Isotretinoin is a retinoid and is frequently used in the treatment of rosacea. You should carefully follow the directions of your physician if you are prescribed this treatment for rosacea and frequently monitor your treatment and discuss any concerns you may have about this drug with your physician. The RRDi would be remiss if we did not give you the following information about the risks and benefits of this treatment for rosacea. 

Many rosaceans report taking low dose isotretinoin for rosacea and are very happy campers. However, there are some who are not happy. You should know as much as you possibly can about this drug if you are taking it for your rosacea. 

Oral isotretinoin is marketed under various trade names, most commonly Accutane (Roche), Amnesteem (Mylan), Claravis (Barr), Isotane (Pacific Pharmaceuticals), Sotret (Ranbaxy), or Roaccutane (Roche); while topical isotretinoin is most commonly marketed under the trade names Isotrex or Isotrexin (Stiefel). If fact, isotretinoin has become quite popular with rosaceans who report that taking low doses works marvelously for them in controlling rosacea. For an example of a recent clinical report on the use of isotretinoin:

"Recently, a big randomized double-blind dose-response and comparative study revealed that an optimized dosage of 0,3 mg/kg was superior to other dosages and non-inferior to doxycycline as gold standard of systemic rosacea treatment and proved effective and safe in papulopustular and phymatous subtypes. However, the substance is still not licensed for this indication The efficacy of isotretinoin in rosacea is probably mainly related to anti-inflammatory mechanisms as well as anti-oxidative, anti-angiogenic and antifibrotic properties. The classical antiseborrheic effect of isotretinoin might play a role in special subtypes like the phymatous type or rosacea fulminates." [4]

One side effect may be Myositis Induced by Isotretinoin, even at low dose. [7]

Accutane is being prescribed for rosacea more than ever according to anecdotal reports. More reports of accutane treatment for rosacea in low dose prescriptions seem to be the current popular treatment without much discussion on the risks and side effects. Accutane was initially used to treat acne but has become quite common to hear of physicians prescribing it for rosacea. However, particularly pregnant women should be warned clearly of the risks associated with accutane. In addition, a rosacean should ask his doctor what are the risks associated with taking accuatane, including the side effects and determine if the risks are worth the benefits. This what is called the risk-benefit analysis. If you decide to accept risks of this treatment, you will discover later what these risks are for yourself but at least you were warned. Taking Accutane without considering the risks is like jumping into a dark deep hole blind folded. What you land on could hurt later.

One report describes dermatologists who prescribe isotretinoin as "isotretinologists" who need to "to save this wonderful drug from oblivion." [5]

"In a recent case in New Jersey, a former user of the acne medication Accutane has been awarded over $25 million after the medication was found to cause inflammatory bowel disease. The plaintiff, 38-year-old Andrew McCarell, testified that he had begun using the medication in 1995. His worsening bowel conditions required five surgeries. Finally, his colon had to be removed.

Accutane has created an ongoing legal nightmare for its developer, Roche Holding AG. The company stopped selling the drug in June of 2009 because of the numerous complaints it received, although its spokespersons still say that competition from generics—and the high cost of defending against personal injury lawsuits—are the real reasons why the drug was discontinued. Roche has had over 1,000 (one thousand!) law suits concerning Accutane. Virtually all have argued that the company has never adequately warned of its risks. The drug, which came onto the market in 1982, has been blamed for many health problems including depression, Crohn’s disease, and birth defects. F. Hoffmann-La Roche Ltd. apparently will continue to manufacture and distribute Roaccutane outside the USA. Other manufacturers have continued to market isotretinoin since Roche's patent on the drug has now become generic and anyone can manufacture it in the USA. So isotretinoin is still widely available in the USA. 

Unsurprisingly, a statement issued by Roche pretends to empathy but disavows any responsibility:

'Our sympathies remain with Andrew McCarrell over his disease. Both the finding and the amount of damages were unsupported by the evidence. Roche acted appropriately in providing information about Accutane, including a direct warning about inflammatory bowel disease, to the medical, scientific and regulatory communities.'

Roche is planning to attempt to have McCarell’s award reduced or eliminated on appeal—along with all the others." [1]

Accutane (Isotretinoin) is a very powerful, yet equally dangerous, prescription drug used to combat acne rosacea. Accutane is mainly used to minimize (or shut down) the oil gland activity. Since excessive oil gland activity is linked to severe acne, Accutane has been touted as the closest thing to an acne cure. However, since excessive oiliness is only one facet to the acne rosacea disease, the results are always temporary.

At first, the drug seems to work wonders. Patients will notice a huge decrease (about 6 out of 10 will have up to 100% clarity) in their acne rosacea lesions, flushing, and redness. It may take months, or it may take a couple years, but the acne rosacea will usually return. Plus, the acne rosacea will usually become much more serious because of three things: (1) your skin needs a normal flow of oil to help lubricate and cleanse itself. By restricting this basic action, you're asking for more internal problems to manifest themselves; and (2) the liver becomes damaged from the use of this drug. The liver is the most important organ in regards to a clean system (especially for skin care); and last, but not least, (3) You may experience post-accutane rosacea. Read WhyMe?'s Report on using Accutane.

Here are some of the common side effects: Severe dry skin, Itching Rashes, Chapped Lips, Nose bleeds, Headaches, Nausea, Blurred Vision, Mood Swings, Stomach Pains, Diarrhea, Rectal Bleeding, Joint Pains, Muscle Pains, Yellowing of Skin, Sensitivity to Sun, Decreased Night Vision, Hair Loss (even yrs later), Depression, Thoughts of Suicide, Increased Blood Fat Level, Birth Defects, Loss of Visions, Arthritis.

"Dysfunctional meibomian glands often cause dry eyes, one of the more common eye conditions.....Meibomian gland dysfunction may be caused by some prescription medications, notably isotretinoin." Wikipedia

Drug interactions

The concurrent use of isotretinoin with tetracycline antibiotics or vitamin A supplementation is not recommended. Concurrent use of isotretinoin with tetracyclines significantly increases the risk of idiopathic intracranial hypertension. Concurrent intake of Vitamin A supplementation increases the risk of vitamin A toxicity.

Concurrent use of isotretinoin with methotrexate increases the risk of hepatotoxicity and may increase methotrexate levels. The combination is used with caution and close monitoring of adverse effects and liver function tests.

source > http://en.wikipedia.org/wiki/Accutane

Please be very careful when considering using this dangerous drug and be informed about the risks.

Accutane has become Hoffmann-La Roche’s top-selling product, used by an estimated 5 million Americans alone. Acknowledged as the most effective treatment for the severe, scarring form of acne, increasingly, Accutane is being prescribed for rosacea. This is because more and more rosaceans are demanding this drug from their physician without a doubt. The popularity of Accutane is only exceeded by IPL or other light therapy devices among rosaceans. However, in the past year Accutane has been pulled off the online pharmacy websites in the USA. Why is this?

"Isotretinoin is a known human teratogen, causing birth defects and/or subnormal cognitive performance in prenatally-exposed children." Accutane Litagation Team

One report says isotretinoin, "can transiently raise cholesterol levels and perhaps aggravate inflammatory bowel disease (IBD). source

Ryan Green reports the following:

"Most patients suffering from severe acne tried several, less risk-laden treatments before finally giving the cancer drug Accutane a try. But could other medications, including anti-acne antibiotics, have actually been the cause of what has been called Accutane side effects, including Accutane inflammatory bowel disease?" [2]

Recently an article entitled, Accutane lawsuits and the 'learned intermediary doctrine,' [3]. by David J. Goldberg, M.D., J.D. who serves on the RRDi MAC, explains that physicians may be flying solo if they prescribe Accutane during pregnancy.

Accutane's history is linked to 240 suicides worldwide and Accutane side effects have been a controversial topic since its arrival to the U.S. market in 1982. Your physician might not have mentioned any of this, but you should be aware of the side effects and risks associated with this drug, which may include and are not limited to depression, birth defects, psychiatric disorders, Accutane induced instances of inflammatory bowel disease, lupus, Crohn's Disease, Ulcerative Colitis, Rectal Bleeding, Central Nervous System damage, Bone & Muscle Damage, Hearing & Vision damage, Liver Damage, Pancreatitis, Immune System damage, Lipid (high levels of fats and cholesterol in blood) problems, Kidney damage, shortness of breath, fainting, unusual thirst, or frequent urination, weakness, leg swelling, convulsions, slurred speech, problems moving, serious mental health problems and last but not least, skin damage.

Serious brain problems have been reported. Accutane can increase the pressure in your brain. This can lead to permanent loss of sight, or in rare cases, death.

In some people, Accutane can cause serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, fever, rash, red patches or bruises on your legs or have trouble breathing.

Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach, chest or bowel pain, trouble swallowing or painful swallowing, new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, or dark urine.

These side effects have been serious enough resulting in Roche Accutane labeling changes to occur over twenty times since its approval. Recently the USA FDA made this announcement:

The Food and Drug Administration is announcing the approval of a strengthened risk management program, called iPLEDGE, for Accutane and generic isotretinoin. In addition, the U.S. Food & Drug Administration (FDA) is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online.

"A national registry on Friday began accepting names of Americans who take the anti-acne drug Accutane, part of a federal effort to limit use of the birth-defect-causing drug by pregnant women." source > http://tinyurl.com/akehm

The common less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. People who wear contact lenses may have trouble wearing them while taking Accutane and after therapy. Sometimes, people’s acne may get worse for a while.

One report says, "Teens whose acne is treated with isotretinoin may face twice the risk of eye infections, including conjunctivitis and styes, researchers say." [4]

"Drug-induced myositis should be taken into consideration in the differential diagnosis of myopathic syndromes. Retinoids have the potential to cause varying degrees of myositis and their rapid identification could prevent major complications." [5]

"However, isotretinoin must be used with caution, as paradoxical induction/exacerbation of acne fulminans has been reported." [6]

This has made it difficult for some to obtain Accutane [generic name, isotretinoin] online and many rosaceans have been trying to find it online in different countries that are not under the jurisdiction of the USA FDA.

Because of the problems associated with the prescribing of Accutane, several law firms have teamed up for the purpose of "achieving justice and results for Accutane victims." 

Roche is countering all this with information and their own team of lawyers. Physicians are still prescribing isotretinoin for rosacea, usually in low doses. Many rosaceans are reporting success using this drug for rosacea. But I have written this editorial for you to be aware of the risks involved. Buyer beware. Remember you are still the customer even if your physician views you as a patient and Roche views you as a user.

Low Dose Study Shows Isotretinoin Just as Effective as Doxycycline
Systemic isotretinoin in the treatment of rosacea - doxycycline- and placebo-controlled, randomized clinical study.
Gollnick H, Blume-Peytavi U, Szabó EL, Meyer KG, Hauptmann P, Popp G, Sebastian M, Zwingers T, Willers C, von der Weth R.
Department of Dermatology and Venereology, University of Magdeburg, Germany.

Summary Background: Systemic isotretinoin has been known for decades to be effective in the treatment of severe forms of rosacea, but it must be used off-label because of the lack of evidence-based data. Patients and Methods: 573 patients with rosacea subtype II and III received one of three different dosages of isotretinoin (0.1 mg, 0.3 mg, or 0.5 mg per kg body weight), doxycycline (100 mg daily for 14 days, then 50 mg daily) or placebo in a double-blinded, randomized way for 12 weeks in 35 German centers. Results: Isotretinoin 0.3 mg/kg proved to be the most effective dose with significant superiority versus placebo. Isotretinoin 0.3 mg/kg showed also significant non-inferiority versus doxycycline with reduction of lesions of 90 % compared to 83 % with doxycycline. Investigators diagnosed complete remission in 24 % and marked improvement in further 57 % of patients with isotretinoin treatment, in contrast to remission in 14 % and marked improvement in 55 % of patients treated with doxycycline. Isotretinoin 0.3 mg/kg revealed a similar safety profile as for the treatment of acne. Isotretinoin 0.5 mg/kg showed more dermatitis facialis as compared to 0.3 mg/kg. Conclusions: Isotretinoin 0.3 mg/kg is an effective and well-tolerated therapy option for the treatment of rosacea subtype II and III and can therefore be used successfully as an alternative to therapy with oral antibiotics. J Dtsch Dermatol Ges. 2010 Mar 12.

My comment is if isotretinoin is as effective as doxycycline for severe forms of rosacea, then it would be a prudent to be informed of the risks of both drugs and make an informed decision on which risks you want to live with. It might be that the doxycycline risks are less dangerous than the risks associated with isotretinoin.

Accutane Induced Rosacea

Read the reports

Treatment for Isotretinoin Induced Rosacea

Society and Culture
Accutane is marketed under a number of brand names listed by Wikipedia. Rosacea sufferers have reported taking low dose isotretinoin prescribed by their physicians. 

Additional Sources

Isotretinoin (marketed as Accutane) Capsule Information

Accutane Capsules (isotretinoin) Medication Guide

Roche Accutane Product Informantion


Roche Roaccutane Info

Accutane Side Effects

The Accutane Team

A survey of pregnant women using isotretinoin.
Robertson J, Polifka JE, Avner M, Chambers C, Delevan G, Koren G, Lavigne SV, Martinez LP, Miller RK, Carey JC.
Utah Department of Health, Division of Community and Family Health Services, Birth Defects and Genetics Program, Pregnancy RiskLine, Salt Lake City, Utah.

Wikipedia on Accutane

American Osteopathic College of Dermatology article on Accutane

End Notes

[1] Accutane costs N.J. man his colon—but Roche resists paying up

[3] Could Antiobiotics Cause Accutane IBD?
Ryan Green | July 19th, 2011 | Posted in Accutane Lawsuit News

[3] Accutane lawsuits and the 'learned intermediary doctrine'
David J. Goldberg, M.D., J.D., Dermatology Times, ModernMedicine, Oct. 1, 2006

[4]Isotretinoin associated with eye infection risk
Jun 6, 2012, By: Bill Gillette, Dermatology Times E-News

Rosacea : Systemic therapy with retinoids.
Hautarzt. 2011 Oct 22; Authors: Thielitz A, Gollnick H

[5] Dermatol Ther. 2006 Jul-Aug;19(4):241-50. Coping with the isotretinoin registry. Baldwin HE.

]5] Am J Case Rep. 2020; 21: e917801-1–e917801-6.
Myositis Induced by Isotretinoin: A Case Report and Literature Review
Julián Alejandro Rivillas, Víctor Alfonso Santos Andrade, and Andrés Alberto Hormaza-Jaramillo

[6] Indian Dermatol Online J. 2013 Apr-Jun; 4(2): 133–142.
Paradoxes in dermatology
Keshavmurthy A. Adya, Arun C. Inamadar, and Aparna Palit

[7] Am J Case Rep. 2020 Jan 20;21:e917801
Myositis Induced by Isotretinoin: A Case Report and Literature Review.
Rivillas JA, Santos Andrade VA, Hormaza-Jaramillo AA

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