Accutane Withdrawl 2009
On June 26, 2009, Roche Holding AG pulled its Accutane acne medication from the United States market after juries had awarded more than $33 million in damages to users who said that Accutane caused their bowel disease.
The FDA was notified on this day that it was withdrawing Accutane after finding that it faced challenges from generic competitors and also due to high costs from over 5,000 personal injury lawsuits Roche defends.
Accutane has been prescribed to over 13 million patients since it's approval in 1982. is prescribed
for the treatment of severe, disfiguring cystic acne that has not cleared
up in response to milder medications such as antibiotics. It works on
the oil glands within the skin, shrinking them and diminishing their output.
You take Accutane by mouth every day for several months, then stop. The
anti-acne effect can last even after you have finished your course of
medication.
In April 2008 Pensacola, FL, a $10.5 million verdict was finalized against the makers of Accutane. So far, Roche has lost six cases that have gone to trial over Accutane. Accutane users allege the drugmaker failed to properly warn them the medicine could cause inflammatory bowel disease. The drug also has been linked to birth defects and depression.
Despite all of the data, facts, and lawsuits won that Accutane causes many severe side effects, Roche still stands behind the safety of their drug (however they are withdrawing it now in 2009). The drug also has been pulled off the market in 11 other countries including France, Denmark, Austria, Germany, Portugal, Norway and Spain.
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