Accutane Side Effects

Acknowledged as the most effective treatment for the severe, scarring form of acne, it is no wonder that Accutane has become Hoffmann-La Roche’s top-selling product, used by an estimated 5 million Americans alone. The cure for acne may have come at a price, though, as families and Accutane patients wonder why the manufacturer has failed to adequately warn of the deadly Accutane side effects that can occur. Families of suicide victims are now filing Accutane lawsuits, in addition to some Accutane users who have developed inflammatory bowel disease and lupus that they claim is the result of using Accutane.

Hoffmann-La Roche Cover-Up?

In light of the Accutane lawsuits being filed by families and patients, many people are wondering what extent Accutane manufacturer Hoffmann-La Roche went to in order to minimize the appearance of deadly and severe Accutane side effects. In addition to failing to readily disclose Accutane side effects to the FDA, Roche knew about the birth defects that could occur with Accutane and pregnant women years before ever getting the 1982 FDA approval. Despite this knowledge, the FDA and Roche SMART program aimed at preventing fetal death and birth defects in women using Accutane was not implemented until 2000.

The SMART program was developed only after a 1998 FDA memo recommended “active consideration of removal of Accutane from the market.” The FDA concluded Roche had not acted in good faith when relating information regarding Accutane use in pregnant women.

The reports of psychiatric disorders in Accutane users, including suicide, were repeatedly denied to have any link by the Accutane manufacturer. Accutane was portrayed not as an increased risk for psychiatric disorders such as depression, rather as quite the opposite. Roche tried to imply that acne causes feelings of depression and the use of Accutane may relieve such feelings when helping to treat it. Even after the FDA issued a “Dear Doctor” letter in the beginning of 1998, warning physicians of links between Accutane and “depression, psychosis, and rarely, suicidal ideation, suicide attempts and suicide” and had Roche strengthen warnings to reflect these effects, the company was issued a warning letter after the FDA found the Accutane promotional advertisements to contain “false and misleading” information.

At the December 11, 2002 House Oversight and Investigation Subcommittee Hearing on Safety Issues Relating to Accutane, Congressman Peter Deutsch told Roche North American president and CEO, George Abercrombie that, “what you just said is not a truthful statement” when he claimed the company did try to make consumers aware that Accutane is specifically intended to treat severe acne. Around 90% of all Accutane patients are considered to have mild acne and should have been using an alternate treatment.

The role Hoffmann-La Roche had in the high number of deaths and serious Accutane side effects suffered since 1982 will be battled as Accutane lawsuits have been, and will continue to be filed. Please contact us for more Accutane legal news information and to learn more about Accutane side effects, including birth defects, psychiatric disorders, and possible links to inflammatory bowel disease and lupus. There have been over twenty FDA issued Accutane labeling changes implemented since 1982 in response to the many serious Accutane side effects reported.

IF YOU WOULD LIKE MORE INFORMATION ABOUT ACCUTANE SIDE EFFECTS AND ACCUTANE LAWSUITS, PLEASE CONTACT US.