Accutane is linked to serious side effects like birth defects, thoughts of suicide, depression and bowel disorders. Roche stopped manufacturing it in 2009, but there was no official recall.
Roche’s brand-name Accutane had a market share of less than 5 percent of the market at the time of the decision. A number of generic equivalents of isotretinoin remain available today.
What is Accutane?
Accutane’s chemical composition resembles that of retinoic acid, a compound derived from Vitamin A. The primary application for Accutane is for nodular acne in patients that do not respond to topical applications (such as benzoyl peroxide) and standard antibiotic treatments.
People with severe cases of nodular acne can display red, tender and swollen bumps under the skin. These bumps can have a diameter of a quarter-inch or larger. Left untreated, these bumps can lead to permanent facial scarring and disfigurement. Accutane treats these bumps by slowing the rate of chemical production that leads to skin breakouts.
Accutane: A History of Adverse Reactions
In discontinuing Accutane, Roche expressed no concern about the drug’s safety or effectiveness. However, numerous users of the drug reported harmful responses to it, dating to the time it was first marketed in 1982.
Accutane is linked to serious birth defects when taken by pregnant women. Accutane also is connected with side effects of depression, suicidal thoughts and bowel diseases including Crohn’s.
A 2007 study in the British Journal of Clinical Pharmacology examined women who became pregnant while taking isotretinoin. The study found among 90 pregnant women taking Accutane, only nine had a live birth. Three experienced spontaneous abortion, two had trauma during delivery resulting in the newborn’s death and 76 had elective abortions.
A 2001 article in the New England Journal of Medicine linked Accutane to depression. A U.S. Food and Drug Administration (FDA) study examined 110 people who took Accutane and were hospitalized for depression or attempted suicide. Their ages ranged from 12 to 47.
At a 2009 meeting of the American College of Gastroenterology in San Diego, a research team from the University of North Carolina at Chapel Hill presented the results of a study that showed a higher rate of digestive disorders, including ulcerative colitis, in Accutane users. The UNC study found that Accutane users were 1.7 times more likely to develop Inflammatory Bowel Disease than the general population, while those who had filled at least four Accutane prescriptions were 2.67 times more likely to come down with the disease. Patients with IBD experience diarrhea, abdominal pain, cramping and bleeding.
The UNC presentation also showed that patients who took Accutane had more than four times the risk of developing ulcerative colitis than the general population. Ulcerative colitis is a condition in which the lining of the colon and rectum develops open sores, causing severe pain and irritation during bowel movements.
Despite the studies outlining the negative effects from taking Accutane, Roche declined to denounce its drug. Instead, the company said, “Roche stands behind the safety of Accutane.”
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Lawsuits Play Role
One factor beyond the expiration of patents that may have led to Roche’s decision to discontinue Accutane was litigation. Roche found itself defending thousands of Accutane lawsuits.
By the time Roche stopped making the drug, people who experienced Accutane’s side effects – as well as their families – had filed nearly 1,000 lawsuits against the company. With more patients citing the ill effects of Accutane as reasons for their illnesses, the total number of cases is expected to exceed 5,000.
Thousands of individuals who feel that they developed illnesses because of taking Accutane pursued legal recourse with the help of an experienced Accutane attorney. Many received verdicts to recover medical expenses as well as a measure of punitive and compensatory damages against the manufacturer for lost wages, and pain and suffering.