Accutane is no longer on the market, thanks to dangerous drug lawsuits
Written by: Enjuris Editors
Accutane was once considered a wonder drug for acne treatment. But then people started experiencing issues ranging from stomach upset to mental health problems like psychosis and suicidal tendencies. Although the generic form is still available, Accutane is now off the market and manufacturers are fending off numerous lawsuits. See what’s happening with this dangerous drug now.
Accutane is a retinoid (a strong form of Vitamin A) intended to treat stubborn acne that doesn’t respond to antibiotics or more conservative remedies. Despite its 85% success rate, it’s no longer sold in its branded form; it’s only sold in generic versions, since the original was pulled from the United States market in 2009.
Manufacturer Roche quietly removed Accutane from pharmacy shelves and issued a recall in 2009 after serious side effects including pancreatitis, birth defects, Crohn’s disease, and psychiatric conditions including suicide emerged.
Enjuris tip: The generic name for Accutane is isotretinoin. Although Accutane is no longer on the market, it’s possible to take isotretinoin by prescription. Isotretinoin has the same side effects and dangers as Accutane, so know the risks before you take this drug.
No one likes acne. No one. We all experienced the teenage years—which often meant acne coupled with other dramatic life events. And some adults continue to have acne long after their teen years are behind them.
Unfortunately, this caused some people to continue taking Accutane long after the negative health side effects were uncovered.
Accutane side effects and complications
Accutane is linked to inflammatory bowel disease, Crohn's Disease, and ulcerative colitis. The Food & Drug Administration (FDA) also received reports of nearly a thousand cases of psychiatric issues between 2001 and 2009, along with several suicides. Accutane lawsuits alleged that the package labeling didn’t properly inform consumers about side effects like depression, psychiatric disorders and suicidal thoughts, as required by the FDA.
Accutane reportedly interacted negatively with a wide variety of medications and caused some serious side effects. In addition to the serious digestive and psychological conditions, Accutane patients reported experiencing:
Dry skin, eyes and lips
Pressure buildup in the skull (pseudotumor cerebri)
Decreased night vision
Severe pain in upper stomach
Another serious condition shown to be caused by Accutane was Stevens-Johnson Syndrome. This is a severe skin reaction that can be debilitating or even fatal. It includes a burning sensation, blisters, rashes, and skin separating from the body.
FDA actions on Accutane
The FDA added a black-box warning to the Accutane label in 1984 for the high risk of birth defects. A pregnant woman who takes Accutane is at risk of causing serious damage to her child, including:
Ear and eye abnormalities
Brain and heart problems
There were even anti-pregnancy advertisements on the Accutane packaging that screamed, “DO NOT GET PREGNANT.”
A system called iPLEDGE REMS (risk evaluation and mitigation strategy) was instituted in 2005. It required pharmacies, female patients, and doctors to enroll and approve Accutane prescriptions on a case-by-case basis. Patients had to provide negative pregnancy tests to receive each 30-day prescription, and tests had to be conducted at approved laboratories.
In addition, female users of Accutane had to use two methods of birth control if they were sexually active.
Types of Accutane lawsuits
There isn’t just one type of lawsuit. Multidistrict litigation (MDL) is a legal procedure where cases from various states that share common facts are grouped together. This lets the courts streamline the discovery process, since every plaintiff will request the same sort of evidence from the defendant.
The FDA approves generic isotretinoin as a treatment for severe acne, though it was classified as “Class X,” meaning the drug should be avoided during pregnancy.
The FDA requires a black box warning that alerts the consumer about the dangers of the drug when taken during pregnancy.
Studies show a link between Accutane and depression. Physicians are warned that there are psychiatric effects associated with the drug.
The FDA requires the manufacturer to submit quarterly reports about psychiatric adverse events.
The FDA issues alert to physicians, telling them to monitor patients for suicidal thoughts or actions.
The first Accutane lawsuits are filed. Plaintiffs receive $7 million and $2.6 million in jury trial awards.
There are currently no active Accutane MDL cases pending in any of the United States District Courts. Until recently, there were 2,000 cases pending, but as of August 1, 2018, the Supreme Court in New Jersey just tossed them out because of the unreliability of related scientific evidence.
Roche had a victory in October 2018, when the New Jersey Supreme Court ruled that an FDA-approved label is adequate to warn of pharmaceutical side effects. The ruling closed cases for 532 plaintiffs in product liability Accutane lawsuits. This particular case was about whether the Accutane warning about inflammatory bowel disease (IBD) was sufficient.