Injuries Caused by Accutane®
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The acne medication Accutane® was withdrawn from the market in June 2009. Its Swiss manufacturer Roche AG said the drug was being recalled for business reasons and not because of safety issues. The company said it stands behind the safety of the medication.
In 2002, generic versions of Accutane® became available, reducing Roche’s market share for the drug. Also, the company was being inundated with lawsuits from patients saying the medication had harmed them.
Hundreds of individual lawsuits as well as class action lawsuits are being pursued against the company for the harmful or long term side effects Accutane® has caused patients.
On June 29, 2009, Roche Pharmaceuticals issued a news release from Nutley, N.J., saying it had notified the U.S. Food and Drug Administration (FDA) of its intent to immediately discontinue the manufacture and distribution of Accutane, or isotretinoin.
“This decision,” the release stated, “is being taken for business reasons during a reevaluation of our product portfolio of medicines that are now available from generic manufacturers, and is not being taken for reasons of safety or efficacy.” The company went on to say it stood behind the safety of the drug.
Safety and efficacy are the two most important parameters a new drug must meet for the FDA to allow it on the market. The release said that since 2002 when generic forms of Accutane® entered the market, “Roche’s prescription market share of Accutane® had steadily declined for several years and is now below 5 percent.”
In March 2007, five years after the medication became available in generic form, the FDA launched a Web page to warn consumers of the dangers of buying isotretinoin online. The warning was meant to come up on search results for Google as well as an online search for the drug under any of its generic brand names:
The release also referred to the strict distribution program called iPledge, that involves physicians, pharmacists and patients in an effort to regulate the medication and ensure it was not sold to women who were pregnant or were of childbearing age. The distribution program was designed to prevent the sale of isotretinoin over the Internet.
If you have been harmed as a result of taking Accutane®, you should contact an Accutane® attorney. Our Accutane® lawyers specialize in helping people who believe they’ve been harmed by this medication seek financial compensation. Your initial consultation to explore the merits of your case is free. Contact an Accutane® lawyer today by calling toll free (877) 612-9867.
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