




Accutane Lawsuit
Accutane (isotretinoin) is a strong oral medication used in the treatment of severe acne in patients who have not had success with other skin treatments. Initially used as a chemotherapy agent to treat cancer patients, researchers noted the ability of the medication to treat whiteheads, red pimples and blackheads associated with acne.
Legal Assistance
Legal assistance is available for patients who may have experienced negative side effects associated with Accutane treatment. If you were took Accutane and experienced severe side effects during your treatment, you may wish to speak with a lawyer and ask how you may receive compensation to cover the cost of medical expenses, pain and suffering caused by Accutane. For additional information about Accutane lawsuits, please call 1-800-439-8180 or fill out the form below.
Serious side effects such as liver disease, depression and ulcerative colitis have been linked to Accutane use. Additionally, the U.S. Food and Drug Administration (FDA) has placed a Black Box warning on Accutane and other isotretinoin medications to caution consumers about the risk of severe birth defects if taken by women who are pregnant. The manufacturer of Accutane, Roche Pharmaceuticals, has already been named in thousands of lawsuits filed by individuals who experienced these side effects following Accutane use.
Inflammatory Bowel Disease
A 2006 study published in the American Journal of Gastroenterology noted a link between the use of Accutane and the development of inflammatory bowel disease (IBD) in the form of the chronic gastrointestinal conditions known as ulcerative colitis and Crohn's disease.
While ulcerative colitis and Crohn's disease produce similar symptoms, the conditions affect different sections of the digestive tract. Individuals with ulcerative colitis may experience swelling and ulcers on the surface of the lining of the top-most layer of the large intestines, while those with Crohn’s disease may experience a thickening of the intestinal wall, especially in the last section of the small intestines and the first section of the large intestines.
The development of IBD related to Accutane treatment has prompted the filing of thousands of lawsuits against Roche Pharmaceuticals. One woman diagnosed with ulcerative colitis received a $10.5 million award for her pain and suffering, in addition to $78,500 for medical expenses. The woman's attorneys successfully proved that the company was aware of the potential risk of IBD from Accutane use and failed to report it to the FDA.
Accutane & Risk of Suicide
The suicide risk associated with Accutane has repeatedly been denied by Roche Pharmaceuticals over the years, despite numerous reports that the medication can cause depression, psychosis and suicidal thoughts or actions in certain patients.
In 1997, the FDA approached Roche Pharmaceuticals about reports of psychiatric problems which surfaced among Accutane patients. The following year, it was discovered that Roche failed to notify the FDA that French health authorities had already required Roche to include "suicide attempt" warnings on Accutane warning labels.
By 2000, the FDA had linked 147 known cases of suicide to Accutane, and U.S. Accutane warning labels were finally updated to include a possible risk of adverse psychiatric effects.
Recent Accutane Lawsuits
In June 2009, Roche Pharmaceuticals removed Accutane from the U.S. market, citing sluggish sales due to growing competition from generics as a key reason for the removal. However, at the time of the removal, Roche faced a string of lawsuits filed by plaintiffs claiming that the company failed to provide proper warning about the potential dangers of the medication.
In February 2010, the manufacturer was forced to pay more than $25 million to a man who developed inflammatory bowel disease years after he had taken Accutane.
An estimated 5,000 personal injury lawsuits have been filed against Roche Pharmaceuticals, claiming that the company failed to adequately warn patients of the risk of bowel problems associated with the medication. Many additional lawsuits have been filed against the company for adverse reactions to Accutane, which may include an increased risk of suicidal thoughts, psychiatric side effects and additional gastrointestinal disorders.
Sources:
- http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107086.htm
- http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm
- http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.DrugDetails
- http://online.wsj.com/article/SB120890352155036159.html?mod=dist_smartbrief
- http://www.house.gov/stupak/accutane_chronology.shtml
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