Accutane Available Only on iPledge Program
The Swiss pharmaceutical company Hoffman-La Roche is the maker of the prescription drug Accutane that is used in the treatment of severe cystic acne. This drug was introduced to the market in 1982 and has been a source of serious medical and regulatory controversy because of severe and life-threatening side effects. Reported Accutane side effects include inflammatory bowel disease, birth defects, suicide, and skin disease.
The FDA was especially alarmed about Accutane side effects that increased the risk of birth defects in children born to women taking Accutane. Reports of these Accutane side effects indicate that women taking Accutane have a 30% risk of having children born with birth defects as compared to a 3-5% risk in the general population. In response to this large increase of risk, the FDA established a special program called the iPledge Program to protect women of childbearing age from Accutane side effects. This program requires that women seeking Accutane prescriptions register for the program, sign agreements to use birth control, and undergo pregnancy testing before, during, and after taking Accutane. Because of the serious risk of Accutane side effects, these patients must read all program brochures and agreements, and sign a risk management document. The iPledge program applies to Accutane as well as its generic forms, such as Amnesteem, Clarvis, and Sotret, and was designed to decrease the risk of birth defects associated with this acne drug.
Additionally, in 2007, the FDA posted a web page warning consumers about purchasing Accutane and its generics over the Internet without a prescription, warning of Accutane’s side effects and association with birth defects. In fact, distribution of Accutane and generics outside of the iPledge program is in violation of FDA regulations for the safe use of this acne medication.
Roche Recalls Accutane
In 2008, Roche was faced with a number of Accutane lawsuits involving Accutane side effects. These Accutane lawsuits claimed that patients developed some form of inflammatory bowel disease caused by Accutane. With these Accutane lawsuits, many juries found that Roche did not inform consumers and physicians about the dangers of taking Accutane. Roche has paid out millions of dollars due to Accutane side effects.
Health Canada has reported a number of Accutane side effects that involve severe skin reactions known as Stevens-Johnson Syndrome (SJS). This disease causes skin to burn from the inside out, producing severe blisters that may allow the skin to separate from the body. When this skin disease spreads to more than 30% of the body, the condition is known as Toxic Epidermal Necrolysis (TEN), and the consequences are often fatal. Treatment requires an Intensive Care Unit or Burn Unit.
On June 26, 2009, Roche issued an Accutane recall, pulling Accutane off not only the United States market, but also a number of other countries, due to dangerous Accutane side effects including possible links to inflammatory bowel disease, psychological side effects, and birth defects. Currently, Roche is facing hundreds of Accutane lawsuits relating to these Accutane side effects.
If you have taken Accutane and believe you have experienced Accutane side effects, you may be entitled to compensation for lost wages, pain and suffering, and hospital costs. If you or a loved one has been injured by Accutane’s side effects, or if you would like more information about a potential Accutane lawsuit, please contact us today. Our Accutane lawyers are available to discuss your legal options.