Roche, the largest maker of cancer products, initiated an Accutane Recall in 2009 after having to award millions of dollars in damages to users of this drug. Accutane (isotretinoin) is a prescription drug used to treat severe forms of nodular acne that has not responded to other treatments. Unfortunately, Accutane was commonly prescribed to patients who had only mild forms of acne placing more consumers at risk of experiencing Accutane side effects. Roche informed the FDA that it was beginning an Accutane Recall after evaluating this drugs potential on the market given that generic forms were now available. This Accutane Recall has not come too soon. This Accutane Recall has spun an Accutane Recall Lawsuit across the United States as well as a number of other countries.
More than thirteen million people have been prescribed Accutane since it became available on the market in 1982. Accutane was Roche’s second largest drug seller before its patent expired in 2002. An Accutane Recall lawsuit has been filed with more than 5,000 personal-injury claims and more are to come.
Over time numerous warnings have had to be added to Accutane packaging. The FDA has required a number of revisions as well as a “Black Box” warning on isotretinoin including Accutane and other brand names such as Amnsteem, Claravis and Sotret. Serious side effects listed involve inflammatory bowel disease including ulcerative colitis and Crohn’s disease, birth defects, depression, suicidal thoughts and suicide. The “Black Box” warning became a prelude to an Accutane Recall and the beginning of an Accutane Recall Lawsuit.
One of the first major side effects observed with Accutane therapy was birth defects. Early warnings stated that female patients who are pregnant or will become pregnant must not use Accutane due to the increased risk of birth defects. Birth defects have been documented that include face, eyes, ears, cleft palate, hydrocephalus, other central nervous system complications, cardiovascular, thymus and parathyroid abnormalities. IQ scores have been recorded that were lower than 85 with or without the presence of other abnormalities. There is also an increased risk of spontaneous abortion and premature births. With serious birth defect complications, it was just a matter of time before an Accutane Recall would come to pass and open the door for an Accutane Recall Lawsuit.
Because of Accutane’s teratogenicity (generating birth defects) and to minimize fetal exposure, Accutane was only approved for marketing under a special restricted program approved by the FDA. This program is known as the iPLEDGE system. This program tries to ensure that Accutane is only dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are also registered and meet all the requirements of the iPLEDGE system. There have been nearly 1,000 reported defective births and over 10,000 miscarriages linked to Accutane therapy. Again, indicating a necessity for an Accutane Recall.
Accutane Recall Lawsuit
If you have taken Accutane and have experienced inflammatory bowel disease including ulcerative colitis or Crohn’s disease, birth defects, depression, or suicidal thoughts you might want to talk with an Accutane lawyer to see if you qualify for an Accutane Recall Lawsuit. You need to contact an Accutane attorney about an Accutane Recall Lawsuit as soon as possible as there is a limited time frame when lawsuits may be filed.
You May be entitled to Compensation, so act now.
If you or a loved one has been injured as a result of Accutane therapy, 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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