The FDA confirmed over 5 million patients suffering from nodular or cystic acne have been exposed to dangerous Accutane drug risks since its conception in 1982. Life-changing diseases and birth deformities are among the dangerous adverse effects, and a number of the effects persist after cessation of the medication. Though it was recalled in June 2009, The manufacturer, Roche Pharmaceuticals, continues to deny safety concerns, stating the recall was due to economics.
Suicide and suicidal thoughts, depression, and other mood disorders have been linked to the medication.Roche’s response to the psychiatric problems was to add a warning to the label in 1998. From 1982 to 2005, the drug was linked to over 500 suicide cases, making it one of the most dangerous medications in the United States due to adverse reactions. Experts are not positive why there is a link between the acne medication and psychiatric instability, but the extreme number of cases suggests the link is serious enough to warrant concern.
Severe birth defects are another of the serious Accutane drug risks. The FDA gave the medication a high rating for pregnancy, and it should never be taken while pregnant. There is strong evidence of severe fetal abnormalities in 48 percent of infants born to women taking the medication. Cleft palate, facial deformities, and missing ears are among the common abnormalities plaguing newborn infants born to mothers who were taking or had taken the medication.
Crohn’s disease, ulcerative colitis, and other inflammatory bowel diseases have also been linked to users of all ages. While Roche claims there is no proven link between inflammatory bowel disorders and the medication, early studies show evidence of excessive gastrointestinal bleeding in animals. Bowel obstructions and fistulas are two common Accutane drug risks often requiring surgical removal of large sections of bowel to remedy the life-threatening condition.
In 2008, New Jersey resident Kamie Kendall won a $10.5 million lawsuit after being diagnosed with ulcerative colitis. Just 2 years later, another New Jersey resident, Andrew McCarrel, won $25.16 million from the drug manufacturer after complete removal of the colon and five surgeries. Past patients and their families continue to file lawsuits for other side effects such as suicide, depression, and birth defects.
To date, more than 7,000 lawsuits have been filed claiming serious and debilitating injury and subsequent death.However, the claimants receiving millions for medical expenses and damages do not compare to the large numbers associated with the manufacturer’s revenue. In 2000, Roche’s revenue reached $759.4 million. Though the medication was linked to serious health concerns and birth defects, Roche refused to admit the seriousness of Accutane drug risks.
Generic brands, such as Claravis, Amnesteen, and Sotret, are still available with a prescription, but Roche recalled the medication in 2009 after a black-box warning issued by the FDA. However, past patients still suffer the effects of the dangerous medication that was once marketed for chemotherapy. The children born to mothers who had taken the medication suffer life-long learning disabilities and additional medical problems not always evident at birth.
Nodular or cystic acne have extreme implications in society, and regardless of the age, sufferers long for relief. However, the Accutane drug risks complicate the solution rather than relieve it. Past patients and their families may choose to seek compensation for the life-altering conditions suffered by the medication. Compensation cannot remedy the diseases, but compensation may provide relief financially and medically for those that may have suffered adverse side effects from this drug.