Accutane was discontinued in 2009 for business reasons, not safety concerns. Roche, the company that manufactured the brand-name drug, pulled it from the U.S. market after generic competitors captured roughly 95% of sales. The FDA formally reviewed the withdrawal and confirmed that Accutane “was not withdrawn from sale for reasons of safety or effectiveness.” The active ingredient, isotretinoin, remains widely available under several other brand names.
What Roche Said About the Decision
In June 2009, Roche notified the FDA that it was discontinuing Accutane capsules in all three dosage strengths. Generic versions of isotretinoin had been available since 2002, and by 2009 they dominated the market. Roche spokeswoman Martina Rupp told Reuters at the time: “This was an economical decision driven by falling market share.” Accutane held just 4 to 5 percent of the isotretinoin market when Roche stopped selling it.
The FDA moved Accutane to its “Discontinued Drug Product List,” a category specifically for products pulled for reasons other than safety or effectiveness. This distinction matters because it allowed generic manufacturers to continue referencing Accutane’s original approval when selling their own versions.
Lawsuits Played a Role, Too
While Roche cited economics as the official reason, the company was also facing enormous legal pressure. More than 7,000 lawsuits were filed against Roche, primarily from patients who claimed isotretinoin caused inflammatory bowel disease. Several cases went to trial and produced multimillion-dollar jury verdicts. In 2007, a jury awarded one plaintiff $2.6 million, and a retrial in 2010 raised that to $25 million. Two other plaintiffs won $9 million each in 2012. Roche ultimately succeeded in having most of these verdicts overturned or vacated on appeal, and a court dismissed the majority of the 7,000-plus lawsuits in 2014.
The scientific evidence never supported the bowel disease claims. A meta-analysis of five studies found no meaningful association between isotretinoin and inflammatory bowel disease. Large observational studies, including one tracking nearly 47,000 isotretinoin patients, reached the same conclusion. An analysis of the FDA’s adverse event reporting database revealed that 87.8% of reported cases linking isotretinoin to bowel disease were filed by attorneys, compared to just 6% by physicians. Still, defending thousands of lawsuits was expensive and likely made the shrinking brand even less worth maintaining.
The Drug Itself Was Never Banned
Isotretinoin is still prescribed in the United States and remains one of the most effective treatments for severe acne. The FDA originally approved it in 1982 for severe nodular acne that doesn’t respond to other treatments, including antibiotics. The American Academy of Dermatology also recommends it for patients whose acne causes significant scarring or psychological distress.
Today, isotretinoin is sold under the brand names Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. These are chemically identical to the original Accutane. If your dermatologist prescribes “isotretinoin,” you’re getting the same drug Roche once sold.
Why Isotretinoin Carries Strict Prescribing Rules
Even though the drug wasn’t pulled for safety reasons, isotretinoin does carry real risks that explain why it’s one of the most tightly regulated medications in the country. The biggest concern is birth defects. Isotretinoin causes malformations in up to 35% of infants exposed during pregnancy. These can include absent or malformed ears, heart defects, cleft palate, and abnormally small head or jaw. Between 1982 and 2000, Roche reported nearly 2,000 pregnancy exposures and 162 infants born with defects.
To prevent pregnancies during treatment, the FDA created the iPLEDGE program, a mandatory risk management system that became compulsory in 2006 after advisory committees flagged ongoing problems in 2000 and 2004. Under iPLEDGE, patients who can become pregnant must take a pregnancy test before starting treatment and continue testing throughout their course. Prescriptions must be picked up within a 7-day window, and if that window is missed, a new pregnancy test is required. Prescribers, patients, and pharmacies all must be registered in the system. The FDA approved updates to iPLEDGE in early 2026 that streamline some of these requirements, including allowing at-home pregnancy tests during and after treatment rather than requiring every test in a medical setting.
What About Depression and Suicide?
The other concern that fueled public worry about Accutane was a possible link to depression and suicidal thoughts. This was widely covered in the media and contributed to the drug’s controversial reputation. The most comprehensive look at this question, a meta-analysis of 25 studies covering more than 1.6 million participants published in JAMA Dermatology, found that the one-year risk of depression among isotretinoin users was 3.83%, and the risk of suicide attempt, suicidal thoughts, and self-harm were each below 0.5%.
More importantly, when researchers compared isotretinoin users to nonusers, they found no increased risk of psychiatric disorders overall. Isotretinoin users were actually less likely to attempt suicide two to four years after treatment, possibly because clearing severe acne improves quality of life and mental health over time. This doesn’t mean mood changes can’t happen during treatment for individual patients, but at a population level, isotretinoin does not appear to drive psychiatric harm.
The Short Version
Roche stopped selling Accutane because generics made it unprofitable, and thousands of lawsuits (most of which were ultimately dismissed or overturned) made it a legal liability. The drug itself was never found unsafe or ineffective by the FDA. Isotretinoin remains available, widely prescribed, and considered the gold standard for severe acne that hasn’t responded to other treatments.