ArtsAutosBooksBusinessEducationEntertainmentFamilyFashionFoodGamesGenderHealthHolidaysHomeHubPagesPersonal FinancePetsPoliticsReligionSportsTechnologyTravel

Accutane (isotretinoin) - Will it be Pulled from the Market?

Updated on January 21, 2011

What is Accutane?

Isotretinoin (Accutane) is a drug originally designed to treat brain and pancreatic cancer as well as other forms of cancer. Accutane (isotretinoin) is still used for this for purpose as it is a non-selective systemic (body-wide) agent capable of arresting the growth of rapdily dividing cells.

Isotretinoin is an old drug as drugs go, having been discovered in the 1930s. It is also marketed under the names:

  • Amnesteem (Mylan)
  • Claravis (Barr)
  • Clarus (PREMPHARM)
  • Decutan (Actavis)
  • Isotane (Pacific Pharmaceuticals)
  • Izotek (BlauFarma)
  • Oratane (Genepharm Australasia)
  • Roaccutane (Roche Pharmaceuticals)
  • Sotret (Ranbaxy)
  • Isotrex or Isotrexin (Roche Pharmaceuticals)

How it Came About
Originally, high doses of fat soluble vitamin A could be used to treat severe cases of acne. These doses tended to reduce the production of sebum, an oily substance produced around hair follicles.

The doses recommended for this treatment were upwards of 500,000 IU of vitamin A per day. However, such high doses are toxic.

Hoffmann-La Roche Pharmaceuticals found a derivative of vitamin A which is called isotretinoin; they gave it the brand name Accutane. This derivative was first marketed in 1982.

Rouche made two hundred million dollars in sales per year until the patent expired in 2002. That's a potential total return of four billion dollars.

Isotretinoin molecule
Isotretinoin molecule

Is Accutane on it's way Out?

Roche Holding (formerly Roche Pharmaceuticals) began pulling it's version of isotretinoin off the shelves in mid June 2009. This amid early warnings that drug is linked to inflammatory bowel disease (IBD). The last week of October 2009, a study was published that gave those risks a number. The study found that users of Accutane have almost twice the risk of developing IBD as non-users. Considering all of the other problems with Accutane this may represent the "last nail in the coffin" of this popular, yet controversial drug.

Though Roche has pulled it's stocks, generic versions are still available. However, this latest research could lead to a complete withdrawal of isotretinoin in all it's forms.

In it's twenty-seven (27) year history the drug has been found to cause serious birth-defects, increases the risk of depression, suicidal thoughts, and the various other side-effects listed below.

Side Effects (Toxicity)

Common side-effects to isotretoinoin include:

  • Increased sensitivity to the sun
  • Joint pain
  • Muscle pain
  • Headaches
  • Thinning hair, permanent
  • Thinning skin, permanent
  • Elevated cholesterol
  • Liver toxicity
  • Nose bleeds
  • Pink-eye
  • Rosacea
  • Back pain

Rare, but serious side-effects include:

  • Impaired night vision
  • Cataracts
  • Optic neuritis (inflammation of the optic nerve)
  • Menstrual disturbances
  • Inflammatory bowel disease
  • Pancreatitis (inflammation of the pancreas)
  • Hepatitis (injury to the liver)
  • Corneal opacity
  • Papilloedema (increased pressure on the optic disc [where the nerve connects])
  • Idiopathic intracranial hypertension (increased pressure within the skull)
  • Skeletal hyperostosis (overgrowth of bone)
  • Psychosis

Clinical Use

Accutane is only recommended when other acne treatments fail. A course of treatment typically begins with topical (on the skin) medications such as benzoyl peroxide, followed by a course of antibiotics (oral/and or injected), and finally Isotretinoin.

Because of the toxicity dangers, isotretinoin is a closely monitored course of treatment and therefore more expensive due to more frequent doctor visits and blood serum level tests. The medicine itself is also expensive with cost per dose rising incrementally by milligram.

As a drug, isotretoinoin is a cumulative drug, in other words it must build up in the blood-stream to be effective. This is another factor in cost as repeated blood-serum level tests must be performed to attain 120–150 milligrams per kilogram. (mg/kg).

Because it's a cumulative effect drug Isotretoinoin must be administered, usually twice daily, for three to six months. At the end of the three to six months patients may be required to begin the regimen again if severe acne recurs in the one to two month hiatus after the end of the fist course of treatment.

Birth Defects

Isotretinoin is also linked to a high level of birth defects.  More common types of birth defect including hearing and visual impairment, missing earlobes, facial dysmorphism, and mental retardation.

Between 1982 and 2003 two thousand (2,000) women became pregnant while on Isotretinoin therapy with most pregnancies ending in abortion or miscarriage. Of the two thousand, one hundred sixty babies were born with birth defects.

In response the Food and Drug Administration began a campaign called iPLEDGE.

iPLEDGE is a web-site/program started in March 2006 and run by the FDA. Before a patient can be prescribed Accutane (or any other form of Isotretinoin) health-care providers and their patients must register on the web-site before a course of treatment can begin.

Alternative Treatments

First and foremost, since Accutane (and it's generic variants) are prescribed for serious cases of acne the following may not produce the desired results.

However, my article on Natural and Technological Treatments for Acne does offer some vastly safer alternatives to drugs such as Accutane.

Heat and light have both been found to be effective against the bacteria that causes acne and food items commonly found in most kitchens are also somewhat effective against acne. Both these technologies and methods are covered in the hub (link above) mentioned.


With all of these side-effects, including such a high potential for birth defects, the only other drug with as many controls is thalidomide. Because of this some former patients and consumer advocates wonder why Accutane is still on the market.

Dr. Steven Stone may hold the answer: "It would be a true disaster if this medication would become unavailable. People don't die of acne, so it's easy to say, 'This is a drug that causes inflammatory bowel disease; let's take if off the market.' But that ignores the psychological harm of severe acne."


The author was not compensated in any way, monetarily, with discounts, or freebies by any of the companies mentioned.

Though the author does make a small profit for the word count of this article none of that comes directly from the manufacturers mentioned. The author also stands to make a small profit from advertising attached to this article.

The author has no control over either the advertising or the contents of those ads.


Submit a Comment
  • LiamBean profile imageAUTHOR


    8 years ago from Los Angeles, Calilfornia

    jeary: I'm sorry to hear that. If it's not working, please stop taking it. The side effects are horrible and the drug ravages the digestive system in more than a few people. There has to be something better you can take to help with this.

    There are law-suits all of the country right now against Hoffmann-La Roche. You might investigate becoming part of the many class-action suits against the company. At the very least you were duped out of good money for quack medicine. At worst your intestines and stomach have been ravage; and it's very serious.

    Don't be a victim. Fight back!

  • profile image


    8 years ago

    i have been on for 6 month it do nothing to my acne it was a a huge lost of money and nastay junk on my face did nt work they should be so pround their work lie to million of coustom to gain money they don't eveny no mechenism to durg mean work

  • LiamBean profile imageAUTHOR


    9 years ago from Los Angeles, Calilfornia

    Thanks Putz. I completely understand why some would face all the risks associated with this drug, after all, IBD is a rare side-effect.. But what I'm seeing is this latest finding my be the "tipping point" for contraindicating this drug for acne.

    And not from a patient's perspective, but from a legal (liability) standpoint for the Pharmas.

  • Putz Ballard profile image

    Putz Ballard 

    9 years ago

    Some thoughts to ponder, I had acne as a teen and use something similar, it worked Hope this med is given close scrutiny.


This website uses cookies

As a user in the EEA, your approval is needed on a few things. To provide a better website experience, uses cookies (and other similar technologies) and may collect, process, and share personal data. Please choose which areas of our service you consent to our doing so.

For more information on managing or withdrawing consents and how we handle data, visit our Privacy Policy at:

Show Details
HubPages Device IDThis is used to identify particular browsers or devices when the access the service, and is used for security reasons.
LoginThis is necessary to sign in to the HubPages Service.
Google RecaptchaThis is used to prevent bots and spam. (Privacy Policy)
AkismetThis is used to detect comment spam. (Privacy Policy)
HubPages Google AnalyticsThis is used to provide data on traffic to our website, all personally identifyable data is anonymized. (Privacy Policy)
HubPages Traffic PixelThis is used to collect data on traffic to articles and other pages on our site. Unless you are signed in to a HubPages account, all personally identifiable information is anonymized.
Amazon Web ServicesThis is a cloud services platform that we used to host our service. (Privacy Policy)
CloudflareThis is a cloud CDN service that we use to efficiently deliver files required for our service to operate such as javascript, cascading style sheets, images, and videos. (Privacy Policy)
Google Hosted LibrariesJavascript software libraries such as jQuery are loaded at endpoints on the or domains, for performance and efficiency reasons. (Privacy Policy)
Google Custom SearchThis is feature allows you to search the site. (Privacy Policy)
Google MapsSome articles have Google Maps embedded in them. (Privacy Policy)
Google ChartsThis is used to display charts and graphs on articles and the author center. (Privacy Policy)
Google AdSense Host APIThis service allows you to sign up for or associate a Google AdSense account with HubPages, so that you can earn money from ads on your articles. No data is shared unless you engage with this feature. (Privacy Policy)
Google YouTubeSome articles have YouTube videos embedded in them. (Privacy Policy)
VimeoSome articles have Vimeo videos embedded in them. (Privacy Policy)
PaypalThis is used for a registered author who enrolls in the HubPages Earnings program and requests to be paid via PayPal. No data is shared with Paypal unless you engage with this feature. (Privacy Policy)
Facebook LoginYou can use this to streamline signing up for, or signing in to your Hubpages account. No data is shared with Facebook unless you engage with this feature. (Privacy Policy)
MavenThis supports the Maven widget and search functionality. (Privacy Policy)
Google AdSenseThis is an ad network. (Privacy Policy)
Google DoubleClickGoogle provides ad serving technology and runs an ad network. (Privacy Policy)
Index ExchangeThis is an ad network. (Privacy Policy)
SovrnThis is an ad network. (Privacy Policy)
Facebook AdsThis is an ad network. (Privacy Policy)
Amazon Unified Ad MarketplaceThis is an ad network. (Privacy Policy)
AppNexusThis is an ad network. (Privacy Policy)
OpenxThis is an ad network. (Privacy Policy)
Rubicon ProjectThis is an ad network. (Privacy Policy)
TripleLiftThis is an ad network. (Privacy Policy)
Say MediaWe partner with Say Media to deliver ad campaigns on our sites. (Privacy Policy)
Remarketing PixelsWe may use remarketing pixels from advertising networks such as Google AdWords, Bing Ads, and Facebook in order to advertise the HubPages Service to people that have visited our sites.
Conversion Tracking PixelsWe may use conversion tracking pixels from advertising networks such as Google AdWords, Bing Ads, and Facebook in order to identify when an advertisement has successfully resulted in the desired action, such as signing up for the HubPages Service or publishing an article on the HubPages Service.
Author Google AnalyticsThis is used to provide traffic data and reports to the authors of articles on the HubPages Service. (Privacy Policy)
ComscoreComScore is a media measurement and analytics company providing marketing data and analytics to enterprises, media and advertising agencies, and publishers. Non-consent will result in ComScore only processing obfuscated personal data. (Privacy Policy)
Amazon Tracking PixelSome articles display amazon products as part of the Amazon Affiliate program, this pixel provides traffic statistics for those products (Privacy Policy)