What is Accutane?
Accutane, or isotretinoin, belongs to a class of drugs called retinoids, chemical compounds related to Vitamin A. Prescribed mainly for the treatment of severe recalcitrant nodular acne when other medication proved ineffective, Accutane and other isotretinoin-type drugs work by shrinking the sebaceous gland. By shrinking this gland, oil production in the dermis is reduced; less oil production results in less clogging of pores and fewer breakouts. Ingested orally in capsule form, the average course of treatment lasts four to six months.
Approved by the FDA in May 1982, the manufacturer, pharmaceutical company Roche US Pharmaceuticals, part of Hoffman- La Roche Inc., offered it to the public in the same year. Before being withdrawn from the market on June 29, 2009, over 13 million people were prescribed Accutane. Roche claims to have withdrawn this product because of financial reasons, but at the time of its removal, Roche was inundated with personal injury lawsuits by those affected by Accutane’s serious and life-threatening side effects. As of today, approximately 5,000 lawsuits have been filed against the manufacturer. Today, isotretinoin is still produced by other manufacturers as a generic drug and under such names as Sotret, Claravis, and Amnesteem.
While Accutane was proven effective for those suffering from severe, often disfiguring, acne, there are many serious side effects resulting from its use.
Miscarriage of Fetus and Severe Birth Defects
In 2004, Nancy S. Green, M.D., medical director of the March of Dimes, stated, “No pregnant woman should ever take isotretinoin, and no woman taking isotretinoin should ever get pregnant.” Studies show that even a single does of Accutane can cause severe birth defects in a fetus affecting the eyes, face, skull, heart, and brain. Because of the severity of these side effects, Accutane and generic isotretinoin products are only available through the iPLEDGE program, a risk-management agency. Started on December 31, 2005, twenty-three years after Accutane’s introduction to the market, the iPLEDGE program requires users, before beginning treatment, to register with the program and sign documents stating they understand the severity of side effects to an unborn fetus and will use two forms of birth control to prevent pregnancy. According to the March of Dimes, Roche reported to the FDA that, “from 1982 to 2000, there were 1,995 pregnancy exposures and 383 live births, of which 162 had birth defects.”
A 2006 study in the American Journal of Gastroenterology found a link between Accutane use and inflammatory bowl disease (IBD) in the form of Crohn’s disease and ulcerative colitis, chronic conditions affecting the digestive tract. Numerous lawsuits have been filed against Roche citing the manufacturer failed to adequately warn patients of the risk of bowl problems associated with taking this medicine. The Dermatology Times reported “plaintiffs have won an estimated $33 million in judgments against Roche for bowel disorders.”
Depression and Suicidal Behavior
Steve Mitchell, UPI Medical Correspondent, reported on December 12, 2002, that, after a two-year study, members of the House Energy and Commerce subcommittee on oversight and investigations found a link between Accutane and suicide. One of the most outspoken proponents of Accutane, Bart Stupak, R-Mich, stated after the report was made public, “In some cases … Accutane results in severe cases of depression, suicide ideation, suicide attempts and suicide.” Stupak’s own son, B.J., died of a self-inflicted gunshot wound in 2000 while taking Accutane.
Have You or a Loved One 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. The lawyers will 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).
Different states have different legislation regarding medical lawsuits, so it is essential to hire an experienced and effective lawyer who can file the case. 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.