Accutane Side Effects

Since 1982, Accutane has been responsible for one of the highest numbers of FDA reported adverse side effects. The reported Accutane side effects have included serious events, including disputed links to suicidal tendencies. Associated to the suicides of 240 people worldwide, associations to such conditions as inflammatory bowel disease, lupus, psychiatric disorders, and birth defects have been made, serious enough to warrant Accutane labeling changes to occur over twenty times since its approval.

About five million people in the U.S. alone have taken Accutane since 1982, however the drug’s popularity has been argued as both positive and negative. Controversy involving Accutane side effects have grabbed the attention of high profile individuals, including Michigan Rep. Bart Stupak who was affected by Accutane side effects on a personal level. Stupak’s 17-year old son was taking Accutane and showed no signs of depression before killing himself in May 2000. Since the death of his son, Stupak has been actively trying to have Accutane removed from the U.S. market until further conclusions on its safety has been established.

The best selling drug for Hoffmann-La Roche, Accutane labeling has been changed a high number of times to reflect the serious nature of the many different reported Accutane side effects. Most recently, Accutane manufacturers added warnings about violent behavior in patients using Accutane in June 2002 and sent letters to doctors and pharmacists regarding the Accutane side effects labeling changes in September 2002.

Although the first Accutane lawsuit that came to a close in April 2002 favored Accutane manufacturer Hoffmann-La Roche, Accutane lawsuits continue being filed for various Accutane side effects. Allegations that Hoffmann-La Roche knew about the life threatening, serious Accutane side effects long before any warnings were issued have been made against the pharmaceutical company. The future of Accutane continues to be shaky as agencies and legislators continue to debate on what the status of Accutane should be in light of the continual reports of serious Accutane side effects and Accutane lawsuits.

Accutane safety has been a concern since Accutane was introduced to the U.S. market. Hoffmann-La Roche has been widely criticized for its seemingly controversial role in failing to prevent many instances of deadly and serious Accutane side effects that has affected many patients and families. The FDA has issued two warning letters to the Accutane manufacturer due to the company’s misleading information.

In 1998, following FDA orders to increase the strength of Accutane warning labels due to psychiatric disorders linked to Accutane, the company began to promote Accutane in a false and misleading manner by stating since acne can cause depression the use of Accutane to clear up acne could be a depression reliever. In fact, Accutane has been blamed for a high number of deaths due to psychiatric disorders resulting from Accutane use. Roche has also been criticized for its unwillingness to supply adverse reaction reports to health officials, resulting in the second 1995 FDA Accutane warning letter.

Accutane lawsuits naming serious, deadly Accutane side effects are underway because many families and patients feel Hoffmann-La Roche has downplayed the dangers for years. Over the course of over twenty years, Accutane labeling has continued to be changed, updated, and strengthened in response to the deaths and dangerous effects experienced.

IF YOU WOULD LIKE MORE INFORMATION ABOUT ACCUTANE AND ACCUTANE SIDE EFFECTS, INCLUDING INFLAMMATORY BOWEL DISEASE, LUPUS, BIRTH DEFECTS, AND PSYCHIATRIC DISORDERS, PLEASE CONTACT AN ACCUTANE SIDE EFFECTS LAWYER.