From: News

Accutane is being pulled from the market by its maker, Roche AG. According to the Associated Press, Roche said the decision to withdraw Accutane was made for economic rather than safety reasons. But as anyone who reads this blog known, over the past couple of years, Roche has lost several Accutane lawsuits, and been ordered to pay more than $33 million to people who claim they were injured by the drug.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the United States. Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems.

Most recently, Roche lost several Accutane lawsuits brought by people who claimed the drug caused them to develop inflammatory bowel disease (IBD). In November 2008, a New Jersey jury ordered the company to pay $13 million to three such plaintiffs. The previous April, another New Jersey jury awarded $10.5 million to a woman who blamed the drug for her ulcerative colitis. In May 2007, another New Jersey trial resulted in an award of $2.62 million to a patient who needed to have his colon and most of his rectum removed after taking the drug. In October that same year, a Florida jury awarded $7 million in damages to another Accutane user who developed the IBD.

In announcing its decision to pull Accutane, Roche did cite the high cost of product liability suits - it currently faces 5000 such lawsuits - involving the drug. But according to Bloomberg.com, the company also said a reevaluation of its product line had shown Accutane faced serious competition from generics.

Roche said Accutane will be pulled in the U.S. and 11 other countries. The last date for distribution in the United States was June 25. According to Reuters, Accutane is now no longer available from Roche directly but patients may still be able to get it from pharmacies.

              

Accutane is used to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars. However, because Accutane can have serious side effects, you should talk with your prescriber about all of the possible treatments for your acne, and whether Accutane's possible benefits outweigh its possible risks.

What are the possible side effects of Accutane?

Brain/Head Injuries.

Stomach problems

Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach, chest or bowel pain, trouble swallowing or painful swallowing, new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, or dark urine.

Bone and Muscle Problems.

Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Muscle weakness with or without pain can be a sign of serious muscle damage. If this happens, stop taking Accutane and call your prescriber right away

Hearing problems.

Some people taking Accutane have developed hearing problems. It is possible that hearing loss can be permanent. Stop using Accutane and call your prescriber if your hearing gets worse or if you have ringing in your ears.

Vision problems.