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Accutane Update

Accutane-02-18-10.jpgTwo contrasting Accutane lawsuit updates in the news today:

First, some background. Accutane is used to treat severe acne and has been associated with a host of problems: birth defects, inflammatory bowel disease, injuries to the liver, kidneys, nervous system, and pancreas, dermatological reactions, and even suicide. Roche stopped selling it last year after a 27-year run, citing competition from generics and the 5,000 pending Accutane lawsuits.

Plaintiff’s Verdict: $25.16 Million

In May 2007, Andrew McCarrell emerged victorious in a New Jersey Superior Court Accutane lawsuit against Roche Holding AG. Mr. McCarrell developed inflammatory bowel disease caused by Accutane. (View the full original trial on video, purchase required). That victory was short-lived, as the verdict was appealed and overturned because the trial judge should have allowed the defendants to present statistical evidence—that there were five million drug users.

But Mr. McCarrell persevered and received a verdict of $25.16 million in a retrial that concluded Tuesday. The jury determined that amount to be just compensation for 15 years of sickness, including five surgeries and colon removal. The jury agreed that Roche failed to warn about the risks of inflammatory bowel disease through the drug’s label. This is the largest of six Accutane verdicts to the sum of $56 million.

Expert Testimony Excluded in Accutane Lawsuit

In one of the suicide cases, New Jersey’s appellate court affirmed a trial judge’s exclusion of the plaintiff’s expert study, used to prove general causation (that is, that the drug in general can cause people to commit suicide). The study was beset by problems, and the court allowed the expert to rework it, but finally ruled that it was not based on the methodology he claimed. The expert, however, may still be allowed to opine that Accutane can cause depression—that’s for the trial judge to decide.

Perhaps this can be chalked up to “win some, lose some.” By all reports, the suicide cases are not doing well, but the other injury lawsuits are gaining momentum.

The Problem with Accutane

Accutane is a brand name for isotretinoin, a medication used to treat severe acne. In 1982, it was approved by the U.S. Food and Drug Administration (FDA) and marketed by Roche Pharmaceuticals. Over the years, Accutane gained popularity as a highly effective treatment for acne, but it also gained notoriety for its numerous side effects (which we talk about below).

In the late 1990s and early 2000s, Accutane was linked to many severe side effects, including inflammatory bowel disease, ulcerative colitis, and Crohn’s disease. In 2002, the FDA issued a warning about the potential risks of Accutane, and in 2005, Roche discontinued the drug in the United States.

In the years that followed, thousands of people who had taken Accutane filed lawsuits against Roche, alleging that the drug caused them to develop severe and life-altering side effects. The lawsuits claimed that Roche had failed to warn patients and doctors about the risks associated with the drug.

In 2007, Roche agreed to settle a large number of Accutane lawsuits that had been filed in New Jersey. The settlement covered cases involving inflammatory bowel disease, ulcerative colitis, and Crohn’s disease.

In 2009, Roche announced that it would stop selling Accutane worldwide, citing competition from generic versions of the drug and the cost of defending against Accutane lawsuits.

Not Just UC and Bowel Disease Side Effects

According to the American Academy of Dermatology (AAD), isotretinoin has been linked to severe side effects such as depression, suicidal thoughts, and inflammatory bowel disease. However, recent studies show no direct causal link between isotretinoin and these conditions. Patients taking isotretinoin still appear vulnerable to psychiatric issues, and nearly 18,000 psychiatric adverse events were reported with isotretinoin use between 1997 and 2017.

Isotretinoin also carries an FDA category X label and a stringent FDA “black box” warning citing the drug’s detrimental effects on a developing fetus. Patients may also experience dry skin, chapped lips, hair loss, nosebleeds, and headaches while taking the drug, and drinking alcohol while taking isotretinoin may increase the risk of side effects.

“Accutane” Still on the Market in 2023

Accutane is gone, but it survives as a generic drug. Six manufacturers currently offer generic versions of isotretinoin, including Amnesteem, Claravis, Myorisan, Absorica, Amneal isotretinoin, and Zenatane, all of which have similar formulas and side effects.

Isotretinoin Side Effects

Common side effects of isotretinoin include:

  • Dryness of the skin, lips, mouth, and nose
  • Itching
  • Skin rash
  • Cracking or peeling of skin
  • Dry eyes and eye irritation
  • Joint pain and stiffness
  • Back pain
  • Muscle pain
  • Nail changes
  • Temporary hair thinning
  • Headache
  • Nausea
  • Vomiting
  • Stomach pain
  • Diarrhea
  • Rectal bleeding
  • Yellowing of the skin or eyes
  • Dark urine
  • Changes in mood or behavior
  • Depression
  • Psychosis
  • Suicidal thoughts
  • Increased blood cholesterol or triglycerides
  • Increased blood sugar
  • Decreased night vision
  • Sun sensitivity

Rare but serious side effects may include:

  • Inflammatory bowel disease (IBD)
  • Pancreatitis
  • Liver damage
  • Increased pressure inside the skull
  • Birth defects if taken during pregnancy

Isotretinoin Defenders

  • According to a 2020 study published in the Journal of the American Academy of Dermatology, isotretinoin, a highly effective acne medication, should still be made available despite its links to depression and teen suicide. The study examined 42 studies involving more than one million people and found a significant association between acne and mental health. The research also found that the psychiatric risk of untreated acne is high, highlighting the importance of optimizing acne management, including using isotretinoin. The study concluded that despite the association of isotretinoin with depression and teen suicide, clinicians should still consider its use as acne can pose a significant risk to mental health.
  • This study in 2019 argues that the suicide risk may be overblown.  The study investigated the risk of suicide attempts associated with isotretinoin, an effective treatment for severe acne. The study used the Nationwide French Health Insurance data from 2009 to 2016 and found that the occurrence of suicide attempts during isotretinoin treatment was markedly lower compared to the French general population. The study also found no evidence of a triggering effect of isotretinoin initiation on a suicide attempt. The findings suggest that selecting patients at lower risk for suicidal behavior and appropriate treatment management could explain these results. The study recommends maintaining risk management plans for isotretinoin use.