Accutane

June 26, 2008

The manufacturer of Accutane, Roche Holding AG, has withdrawn its acne drug Accutane from the U.S. market after several trials during which juries awarded damages of more than $33 million dollars in compensation to injured consumers who alleged that their use caused them to suffer bowel disease including ulcerative colitis, a form of inflammatory bowel disease (IBD).

Accutane had been manufactuered, supplied, marketed and sold to approximately 13 million consumers since it was introduced to the market in 1982. The medication was Roche’s second-biggest selling drug but its sales fell precipitously after it lost its long standing sole patent to generic manufacturers.

Roche communicated its decision to withdraw Accutane from the U.S. market to the Food and Drug Administration. Its spokes person issued a statement in which it failed to accept accountability, saying only:

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously.”

Roche Accepts No Responsibility in Withdrawal of Accutane

The manufacturer of Accutane, Roche Holding AG, has withdrawn its acne drug Accutane from the U.S. market after several trials during which juries awarded damages of more than $33 million dollars in compensation to injured consumers who alleged that their use caused them to suffer bowel disease including ulcerative colitis, a form of inflammatory bowel disease (IBD).

Accutane had been manufactuered, supplied, marketed and sold to approximately 13 million consumers since it was introduced to the market in 1982. The medication was Roche’s second-biggest selling drug but its sales fell precipitously after it lost its long standing sole patent to generic manufacturers.

Roche communicated its decision to withdraw Accutane from the U.S. market to the Food and Drug Administration. Its spokes person issued a statement in which it failed to accept accountability, saying only:

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously.”

Roche Holding AG Recalls Accutane Following Lawsuit Verdict

June 29, 2009

Hoffman-LaRoche, the largest manufacturer of cancer medications, issued a recall for Accutane, an oral medication intended to treat severe acne. Accutane has been widely linked to several adverse side effects since its release in 1984, including psychological changes, suicidal behavior, auto-immune disease, central nervous system problems and birth defects.

In June 2009, Roche announced a recall of the medication after a court decision awarded more than $33 million in damages to victims of Accutane injury. Prior to the June 2009 court order, Roche was required to pay damages in several other cases, including $13 million in November 2008, $10.5 million in April 2007, $2.62 million in May 2007 and $7 million in October 2007.

Facing 5,000 more product liability claims, Roche cited the high cost of lawsuits as one of its main factors in pulling the product. In addition to discontinuing the product in the United States, Roche has also pulled Accutane from 11 other international markets.

Patients are still able to obtain Accutane from pharmacies, but not directly from Roche.

Accutane Side Effects – Accutane Suicide and Bowel Diseases

Accutane has been linked with a wide range of life-threatening side effects, including psychiatric problems. More than 142 suicide cases involving Accutane have been reported to the Food and Drug Administration (FDA). In response, the FDA issued a warning to healthcare professionals to monitor their patients for signs of depression while they are on the medication.

Additionally, several patients claim Accutane caused side effects including musculoskeletal disorders, multiple sclerosis, diabetes, hepatitis, hepatotoxicity, liver damage, kidney damage, lupus, birth defects and fetal death.

Recently, the acne medication has been linked to gastrointestinal disorders, including:

  • Crohn’s disease
  • Inflammatory bowel disease (IBD)
  • Irritable bowel syndrome (IBS)
  • Ulcerative colitis

More than 13 million people in the United States use Accutane, which was once Roche’s second-best selling drug.

Filing An Accutane Lawsuit

In June 2009, a jury awarded victims who developed gastrointestinal problems after taking Accutane more than $33 million in damages. Many other patients are coming forward against Roche and filing a product liability claim after experiencing adverse side effects of Accutane.

To learn more about how you can file a claim against Hoffman-LaRoche, contact the skilled Pensacola, Florida attorneys of Aylstock, Witkin, Kreis and Overholtz at (844) 794-7402.

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