Accutane’s path through the American drug system has been fraught with many highs and lows for its manufacturer the Swiss-based pharmaceutical company Hoffmann-LaRoche, known in the U.S. as Roche Laboratories.  At its height, Accutane, sold as Roaccutane in Europe, brought in over $700 million a year with more than 12 million people using the drug worldwide.  In 2000 alone, sales totaled $759.4.  In the March 1, 2001 edition of FDA Consumer, the U.S Food and Drug Administration’s (FDA) own publication, Accutane was regarded as “the biggest breakthrough in acne drug treatment over the last 20 years.”  Why, then, have more than 5000 lawsuits been brought against the manufacturer, and why was Accutane pulled off the market?

Accutane research began with Dr. Werner Bollage, Swiss scientist for Hoffmann-LaRoche, in the 1960s. Dr. Bollage explored the chemical compound 13-cis retinoic acid’s potential as a treatment for skin cancer.  By 1971, Dr. Bollage realized that the chemical, also known as isotretinoin, failed to treat cancer but succeeded in clearing the acne of patients taking the drug.  Yet, because the drug is a Vitamin A derivative, he also knew that it was a teratogen, a substance that causes malformations in the fetus, and thus abandoned his research for fear of creating a drug with such devastating side effects.

In 1975, Drs. Frank Yoder and Gary Peck, scientist at the National Institute of Health (NIH), independent of Dr. Bollage’s research, began to test 13-cis retinoic acid for the treatment of lamellar ichthyosis, a skin disorder.  They also concluded that while isotretinoin did not alleviate the intended target, it did clear the skin of any subject with acne. Unaware of Dr. Bollage’s initial research with Hoffmann-LaRoche, Drs. Yoder and Peck believed they were the first to discover the cure for acne.

LaRoche registered isotretinoin as Accutane in 1979 and began clinical trials in order to file an application with the FDA.  Roche acknowledged that animals becoming pregnant during testing did give birth to fetuses with severe defects; yet, Roche reported no known human fetal risks. In a statement sent to the FDA, Roche affirmed “no human babies had been exposed to the drug.”  Later reports revealed that during clinical trials Roche avoided using women as much as possible. When women were used, they were required to take pregnancy tests.  The one woman who did become pregnant was urged to have an abortion.  Therefore, the company, by omission, had no data on the effects of Accutane on a human fetus to report to the FDA.

Working with the data supplied by Roche, the Dermatology Drugs Advisory Committee, in 1982, recommended FDA approval, but, because isotretinoin’s reputation as a teratogen, recommended a pregnancy risk rating of C.  A “C” rating, as defined by the FDA, indicates “studies in animals have revealed adverse effects of the fetus and there are no controlled studies in women…. Drugs should be given only if the potential benefits justifies the potential risk to the fetus.”  The FDA accepted the recommendation and approved Accutane in May 1982.  By September, Newsweek hailed Accutane a miracle drug: “There has never been a drug like it.”  Doctors wrote over 200,000 prescriptions in the first six months; the drug’s overwhelming success even surprise Roche.

At the same time, others voiced concern. Dr. Yoder, one of the original researchers, wrote to the Journal of the American Medical Association (JAMA) in a letter dated January 1983, “I wish to express my concern and anxiety over the potential tragedy that might arise from the misuse of Accutane.”  By June 1983, three cases were reported to Roche of babies with severe birth defects being born to women who took Accutane while pregnant. Roche’s response was to send warning letters to doctors and to revise drug labels indicating birth defect risks.  Amid a flurry of adverse event reports, the FDA required a new label with a black box warning—the strongest alert the FDA can impose. Yet, reports of severe and life-threatening side effects still prevailed.

On February 11, 1988, the FDA’s Division of Epidemiology, based on studies of Michigan Medicare patients, urged the FDA to consider removing Accutane from the market.  An estimated 900-1,300 Accutane babies had been born in the U.S. since its approval in 1982. Roche argued against removal but proposed an education program instead. The FDA sided with Roche and education programs were created to prevent pregnancy in women during Accutane treatments.  The original program was updated in 2002 as SMART (System to Manage Accutane Related Teratogenicity) and iPLEDGE in 2006. If a patient did not partake in an education program, then doctors were unable to prescribe or dispense the drug. Additionally, the FDA mandated stronger language on warning labels, information packets, and consent forms. In 1995, the New England Journal of Medicine (NEJM) published the results of a study suggesting the education program was working. Roche reaped the benefit of this report and attention turned away from Accutane for a time.

Yet, education programs were not enough to prevent the serious and life-threatening side effects cause by Accutane use. Between 1992-1999, Roche became the focus of numerous lawsuits compelling the plaintiff’s bar to create a subset called the Accutane Litigation Group.  Additionally, the advocacy group Public Citizen, frustrated with the FDA’s inaction, became more vocal and involved.

Not only were suits brought against the manufacturer for causing birth defects, but, also for its links to psychiatric disorders and inflammatory bowel disease (IBD).

In 2000, Michigan Congressman Bart Stupak’s son B.J., a 17-year-old Accutane user, committed suicide.  Stupak’s utilized his prominence to warn, both in the media and in Congressional hearings, of the link between Accutane use and seeming happy people committing suicide.  By 2001, reports showed 140 Accutane consumers worldwide had committed suicide and another 257 had been hospitalized for psychiatric disorders. That year, the New England Journal of Medicine also found Accutane ranked as one of the top 10 drugs linked to depression and suicide.

The Americal Journal of Gastroentology published a study in 2006 linking Accutane with IBD.  Unlike inflammatory bowel syndrome (IBS), a less invasive disorder affecting the digestive tract, IBDs, such as Crohn’s disease and ulcerative colitis, are incurable chronic diseases of the intestinal tract that causes symptoms such as abdominal pain, fever, and rectal bleeding.  Many IBD sufferers must endure numerous surgeries to try and alleviate pain and discomfort.

Roche’s patent on Accutane expired in February 2002 and other, cheaper brands appeared on the market.  Then, in 2009, following a series of jury verdicts against Roche, the company voluntarily pulled the drug from the market citing high defense costs and low market share.  As of 2012, more than 5,000 lawsuits have been filed and juries have handed down over $56 million in verdicts against Roche.

Many thanks to Julia Green’s article “Babies, Blemishes and FDA: A History of Accutane Regulation in the United States” for providing information regarding Accutane’s history in the United States.  Leda.law.harvard.edu/leda/data/472/Green.pdf

Have You Been Affected by Accutane?

Any individual or the relative of an individual who has suffered due to Accutane’s side effects is permitted to file a lawsuit. Lawyers are available to help you determine whether you are qualified to seek compensation.  You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).  If you need further information about the harmful side effects of Accutane or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.