Why is Accutane no longer sold?

Author: Deja Wolf DVM  |  Last update: Sunday, November 16, 2025

On 29 June 2009, Roche Pharmaceuticals, the original creator and distributor of isotretinoin, officially discontinued both the manufacture and distribution of their Accutane brand in the United States due to what the company described as business reasons related to low market share (below 5%), coupled with the high ...

Why is Accutane no longer available in the US?

A statement by Roche said its decision to withdraw Accutane reflected market pressures and the cost of lawsuits, not safety concerns. Accutane costs about $1,200 a month, and many consumers choose the generics, which cost 25% to 50% less.

Why was Accutane banned?

Although the name is still widely recognized, Accutane was discontinued in 2009 due to lawsuits over side effects and diminishing market share due to the availability of the many generic versions of the drug.

Why is Accutane so hard to get?

Accutane is dispensed only under the rules of iPledge, a government regulated prescription program. The rules of iPledge are very inflexible, so it's important to follow the detailed instructions so that are you are able to get your medication.

Why do dermatologists not like Accutane?

So why does isotretinoin get such a bad reputation? The majority of the controversy stems from the high likelihood to cause birth defects if a female taking the medication were to become pregnant as well as the inconsistent associations with depression, suicide, and inflammatory bowel disease.

Accutane warning

What is a better alternative to Accutane?

What are some Accutane alternatives?
  • Topical retinoids. Isotretinoin is a type of retinoid, but it's not the only one used to treat acne. ...
  • Antibacterial medications. These medications work mainly by killing the acne-causing bacteria in your pores. ...
  • Hormonal treatments.

What age is acne the worst?

Acne is a common issue for many people, especially for teenagers and young adults in their 20s. Some have mild symptoms, while others can have very severe issues. Acne effects around 90% of adolescents with the prime age across all genders being the teenage years of 14-19 years old.

What is the strongest acne medication?

Isotretinoin. Isotretinoin is a treatment for severe acne that comes in capsules. It has a number of beneficial effects: it helps normalise sebum and reduce how much is produced.

Why is Accutane the last resort?

Both types of acne require treatment by a dermatologist; over-the-counter potions and creams simply can't do the job. That's where isotretinoin/Accutane comes in. Prescribers refer to it as the drug of last resort. This is because it clears up nodular and cystic acne when nothing else can.

Why do dermatologists push Accutane?

Accutane combats different causes of acne, including clogged pores, acne-causing bacteria, excess oil production, and skin inflammation. These qualities of Accutane make it an effective treatment for all types of acne, including blackheads and whiteheads.

What organ is Accutane bad for?

Accutane-Related Organ Problems

These symptoms could indicate damage to the liver, pancreas, bowel and esophagus. You should immediately inform your doctor of any of these symptoms. The damage might be permanent even after stopping Accutane, but swift treatment can increase your chances of recovery.

Does Accutane destroy sebaceous glands permanently?

Isotretinoin will reduce pores while you are on treatment as it shrinks sebaceous glands, but the pores will return to their normal size within a few months of stopping Isotretinoin.

Why you should avoid Accutane?

Isotretinoin (Accutane) can improve severe acne, but it can also have adverse effects, such as headaches, eye inflammation, and joint problems. It may also increase the risk of depression and sexual problems. Isotretinoin is a retinoid, which is a class of drugs similar to vitamin A.

Do doctors still prescribe Accutane?

The original medication brand, Accutane, is actually no longer available, but the name has stuck. When you receive your Accutane prescription, you may see it listed simply as isotretinoin or a number of other brand names, including Asorica®, Claravis®, Sotret®, Amnesteem®, Myorisan®, and Zenatane®.

What is grade 3 acne?

grade 3 (moderately severe) – there's a large number of papules and pustules, as well as the occasional inflamed nodule, and the back and chest are also affected by acne. grade 4 (severe) – there's a large number of large, painful pustules and nodules.

What is the new name for Accutane?

Isotretinoin (oral route)

Is Accutane worth the risk?

The risk of developing severe side effects is very low – with only 1 in 500 patients experiencing serious adverse events – and the potential benefits of the treatment are very high, especially for those who have found that no other treatments are effective.

How to protect the liver while on Accutane?

People can also take steps to protect their liver while taking isotretinoin, such as avoiding alcohol, maintaining a moderate weight, eating a nutritious diet, and getting regular exercise.

What is the Accutane purge?

Before your first month of treatment ends, you may experience a paradoxical acne flare, termed colloquially as “Accutane purge.” Skin purging looks like acne exacerbation. That is why you hear some Accutane patients saying, “It gets worse before it gets better.” The cause of the Accutane purge is unknown.

What is the number 1 dermatologist recommended acne treatment?

As mentioned, the best acne product varies for everyone. However, for individuals who are not pregnant, adapalene, benzoyl peroxide, and fixed-dose combinations of these two are the most recommended. Adapalene combined with benzoyl peroxide works as effectively as when either agent is paired with topical antibiotics.

What is the hardest acne to get rid of?

Cystic acne is a type of inflammatory acne that causes painful, pus-filled pimples to form deep under the skin. Acne occurs when oil and dead skin cells clog skin pores. With cystic acne, bacteria also gets into the pores, causing swelling or inflammation. Cystic acne is the most severe type of acne.

At what age does acne normally go away?

Acne is most common in girls from the ages of 14 to 17, and in boys from the ages of 16 to 19. Most people have acne on and off for several years before their symptoms start to improve as they get older. Acne often disappears when a person is in their mid-20s. In some cases, acne can continue into adult life.

What is the root cause of acne?

Sebaceous glands lubricate the hair and the skin to stop it drying out. They do this by producing an oily substance called sebum. In acne, the glands begin to produce too much sebum. The excess sebum mixes with dead skin cells and both substances form a plug in the follicle.

What is a pimple with a hard white ball inside?

Pustules are a type of pimple that contains yellowish pus. They are larger than whiteheads and blackheads. Home remedies and over-the-counter creams may help treat pustules. Pustules appear either as red bumps with white centers or as white bumps that are hard and often tender to the touch.

Why does B12 cause acne?

One of the ten subjects studied developed acne one week after vitamin B12 supplementation. To further understand the molecular mechanism, we revealed that vitamin B12 supplementation in P. acnes cultures promoted the production of porphyrins, which are known to induce inflammation in acne.

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