From the Annals of NIH History (2024)

FAQs

When was Accutane discontinued? ›

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.

Oral isotretinoin (13-cis-retinoic acid) was first approved as treatment for severe acne by the US Food and Drug Administration (FDA) in 1982.

Isotretinoin is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines or antibiotics have been tried and have failed to help the acne. Isotretinoin may also be used to treat other skin diseases as determined by your doctor.

Generic Options

They include formulations marketed under the brand names Absorica, Amnesteem, Claravis, Sotret, and others. A prescription is needed for all of these medications, and they all have the same side effects as 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.

3 – Most People Only Need One Course of Accutane Treatment

After completing the course of medication, the vast majority of people will not need any additional rounds of . While they may see a few pimples or mild breakouts, most never have flareups that are ever as severe again.

It may lead to elevations in liver function tests, but it does not usually cause severe or lasting damage.

There are no reports of problems getting pregnant while taking isotretinoin.

Isotretinoin, sold under the brand name Accutane as well as in generic form, has been available for use in Canada since 1983. The drug is a vitamin A derivative called a retinoid that helps prevent acne by reducing production of an oily skin substance called sebum.

What is the black box warning for isotretinoin? ›

Despite its efficacy in treating acne, isotretinoin has reportedly been associated with suicide and a range of psychiatric disorders, including depression and anxiety,² which has resulted in a black box warning for suicide, depression, aggression, and psychosis issued by the US Food and Drug Administration in 2005.

Accutane “Recall”

These medical conditions include a high risk of suicide, seizures, bone degradation, heart attacks, and strokes. A majority of these lawsuits cover common serious side effects such as those seen relating to the digestive tract such as Crohn's disease and Ulcerative Colitis.

You should avoid certain supplements, especially those containing vitamin A. Accutane is a retinoid. Retinoids are effective acne medications that contain a form of vitamin A. Getting too much vitamin A can lead to toxicity, so it's best to avoid using other products that contain vitamin A while taking Accutane.

It is the closest medication we have to a cure for acne. Because of this, many patients, dermatologists, and other physicians find that treatment is often worth the risk of potential adverse effects. In addition, most patients who complete a full course of Accutane never get acne again.

It has a high success rate of nearly 90% on average for those who complete the 5-month course. About 50% of people who take Accutane report not needing to treat acne again afterward. Of the 5% of patients who do not clear after five months, 50% are completely clear after the second course of Accutane.

Developed by Hoffmann-LaRoche (Roche USA), Accutane brought in billions in revenue. But after growing critics and an ever-increasing fury of Accutane lawsuits, the drug was taken off the market in 2009/2010.

In its tumultuous 27-year history, the drug, also known as isotretinoin, has been found to cause serious birth defects if taken during pregnancy and to possibly increase the risk of depression, including suicidal behavior.

Accutane (not currently marketed in the US) Amnesteem. Claravis.

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.