Was Accutane really discontinued?
I was under the impression that Accutane had been discontinued but not long ago I spoke to someone who was taking it. Has it actually been discontinued for good or was it only temporarily discontinued?
The FDA first approved the active ingredient isotretinoin for the treatment of severe nodular acne under the brand name Accutane in 1982. The brand was discontinued in 2009 due to multiple lawsuits concerning the side effects of the drug as well as a deteriorating market as generic alternatives became more available. However, many people still informally refer to these generic alternatives by the name Accutane.
At present, isotretinoin is available under the names Amnesteem, Claravis, Sotret, Myorisan, Absorica, and Zenatane. All of these generic substitutes contain very similar formulations and similar side effects to Accutane.
There are now, however, more stringent measures around the prescription and use of isotretinoin, including the iPledge program which is designed to prevent women using isotretinoin from falling pregnant while taking the medication. Isotretinoin can only be prescribed to patients 12 or older whose severe acne has not responded to other treatments.
You are correct, Accutane has been discontinued. There are generic forms of Accutane still available, however, under the names Amnesteem, Claravis, Sotret, Myorisan, Absorica, and Zenatane. All of these list isotretinoin as their active ingredient, similar to Accutane.
Isotretinoin is FDA-approved for the treatment of acne, but carries an FDA Category X label which warns of the drug's impact on a developing fetus. Female patients using isotretinoin have to register with an online program called iPledge and commit to preventing pregnancy while taking the medication.
Isotretinoin has also been linked to long-term health problems such as Crohn's Disease and ulcerative colitis. The drug can also adversely affect the central nervous system, cause mental health issues, and impact on night vision. If you are considering using isotretinoin, ensure you seek medical advice.
You are correct, Accutane has been discontinued. However, historically, the generic term for Accutane, Isotretinoin, has been difficult for laymen -- and even providers -- to pronounce. Therefore, when people say they’re “on Accutane for their acne”, the reality is that they’re taking some form of Isotretinoin.
That being said, generic forms of Accutane are still available, except under other names such as Amnesteem, Claravis, Sotret, Myorisan, and Zenatane. Absorica is presently the only “brand name” of Isotretinoin as its formulation involves a particular additional component that has been studied to improve absorption of the medication without having to take it with a fatty snack or meal. All of these medications list Isotretinoin as their active ingredient.
Isotretinoin is FDA-approved for the treatment of acne, but carried an FDA "Category X" label warning of the drug's impact on a developing fetus. The Category system, once deployed for designating medications as very safe to highly teratogenic, was discontinued approximately two years ago, but most providers are still familiar with the previous designations. At this time, pregnancy safety for drugs is a more constricting definition that usually leads people to ask their OB/GYN for better answers, unless of course the medication is known to be highly teratogenic (like Isotretinoin). Female patients using isotretinoin have to register with an online program called iPledge and commit to preventing pregnancy while taking the medication. This usually means using two forms of birth control (i.e. oral birth control pills and male latex condom).
Isotretinoin is contraindicated in patients with a history of cancer or irritable bowel disease (Crohn’s disease or Ulcerative Colitis). The drug will usually lead to dry skin and dry lips, and is occasionally associated with joint pain, headaches, nosebleeds, and changes in night vision. Obviously, if you have any history of contraindicated conditions or serious/intolerable side effects, be sure to consult with your medical provider beforehand and during the course of treatment, respectively.
Accutane was discontinued in 2009 mainly because of mounting lawsuits against its manufacturer, Hoffmann-La Roche. The American Academy of Dermatology recognizes that the drug has been linked to serious side effects such as depression, suicidal ideation, inflammatory bowel disease, and severe birth defects in babies whose mothers were taking the drug, with some patients presenting with adverse effects years after taking the medication. There is however no conclusive evidence or direct causal link that has been discovered.
Although Accutane is no longer available on the market, there are generic versions that have taken its place. Amnesteem, Claravis, and Sotret all contain isotretinoin, the active ingredient of Accutane. Isotretinoin is derived from Vitamin A, which targets cystic acne by reducing oil production (sebum) in the sebaceous glands, clearing clogged pores, attacking the bacteria that causes acne, and reducing inflammation. Users often complain of dry skin, eyes, and lips as a common side effect. Isotretinoin acne medication must be prescribed by a doctor and all patients, providers, distributors, and pharmacists must register with an online risk management program called iPledge.
Accutane stopped being manufactured in 2009 because it was at the end of it's patent and it went generic. Some generic names on the market are Absorica, Claravis, Amnesteem and Zenatane. These are all isotretinoins, just as Accutane was, and work the same way, by reducing oil production.
-Lauren, Patient Coordinator