Important Accutane Information
Accutane (generic isotretinoin) is a prescription drug used to treat patients that have severe cystic acne. Accutane was meant to be used on patients that didn’t respond well to traditional therapies including antibiotics. Isotretinoin is a synthetic form of vitamin A that works on severe acne by inhibiting oil gland secretion. This acne drug was approved for marketing by the FDA in 1982 and has been prescribed to more than 13 million people. Other brand names include Amnesteem, Sotret and Claravis. Many lawsuits have been filed against Roche, the manufacturer of Accutane for adverse side effects. Accutane Side effects include inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), birth defects, liver damage, severe depression, suicidal thoughts and suicide. Accutane Side effects and generic competition eventually brought about an Accutane Recall in 2009.
Accutane Side effects such as ulcerative colitis and Crohn’s disease are similar diseases that affect different parts of the digestive tract. As ulcerative colitis suggests, it involves inflammation of the large intestine (colon) and possible formation of ulcers. Crohn’s disease, on the other hand, has a thickening of the intestinal wall generally in the last part of the small intestine (ileum) and the beginning of the large intestine. These Accutane Side effects amongst others led into an Accutane Recall.
Accutane Recall History
Early on the FDA required a “Black Box” warning on all isotretinoin products including Accutane, to warn consumers and healthcare providers of the potential health risk to unborn children. Accutane has been reported to generate severe birth defects including facial deformities, retardation as well as visual and auditory complications. In some cases these birth defects resulted in death of the fetus. Again, more Accutane Side Effects leading into an eventual Accutane Recall.
Some patients while taking Accutane or soon after stopping Accutane therapy became depressed or experienced other serious mental complications. Accutane Side Effects involving mental complications commonly reported include sadness, anxiety, irritability, anger, lack of motivation, extreme changes in sleep and trouble concentrating. Some patients have reported thoughts about hurting themselves as well as suicidal thoughts. And, some Accutane patients have committed suicide while on Accutane.
Accutane Recall Announcment
In response to criticism from consumers and healthcare providers over the safety of Accutane, Roche initiated an Accutane Recall in terms of the U.S. market along with eleven other countries on June 29, 2009. Roche says that this Accutane Recall was necessary due to competition from generics as well as the expense of personal injury lawsuits they were faced with due to Accutane Side effects. Bear in mind that isotretinoin, the generic form of Accutane is still available under other names in the United States for the treatment of severe cystic acne as well as available over the Internet. The FDA warns about ordering any drugs or medical devices over the Internet. It is a good idea to check with the FDA website on Accutane Side effects, warnings and recalls before purchasing Accutane or for that matter any drug.
You May be entitled to Compensation, so act now.
If you or a loved one has been injured as a result of Accutane, contact us now to speak with our qualified professionals about possible compensation. Call us now at 877-222-7069 or use the contact form for a free case review.
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