Accutane Lawsuit

Accutane lawsuit news has been a pertinent topic to families and patients everywhere ever since the acne medication’s entrance to world markets. Receiving FDA approval in 1982, Accutane has been linked to deadly and serious Accutane side effects from the start. A lucrative drug for manufacturer Hoffmann-La Roche, an estimated five million people in the U.S. have taken Accutane alone, making it the highest profitable drug the company has. Roche appears to have a high number of Accutane lawsuits to battle in the future as insider information has surfaced, indicating the Accutane manufacturer was aware of the deadly effects that could occur but failed to adequately inform the FDA, physicians, and patients of them.

It took almost twenty years for Roche to put into place a safety program to adequately warn women of the birth defects and fetal deaths that occur when using Accutane while pregnant even though the company knew of the serious risk of birth defects since 1971. It was not until the FDA first recommended “active consideration of removal of Accutane from the market” that Roche responded. Even in 2001, research showed women were still not receiving the message that using Accutane drastically increases chances of birth defects.

Roche had denied the connection between Accutane and certain psychiatric disorders, including depression leading to suicide. After French health officials ordered that Roche include warnings of suicide attempts to the Accutane side effects sections in 1997, the company failed to notify the FDA of these developments. Roche could have chosen to warn Accutane users that suicide has been observed in Accutane patients, however they did quite the opposite in attempts to continue promoting the popular medication.

When the FDA told Roche to include warnings of psychiatric disorders, including suicide on Accutane labels, the company advertised nearly the opposite. Roche tried to use the argument that acne causes people feelings of depression and since Accutane is used to treat acne, Accutane was lessening feelings of depression. The FDA responded by issuing a warning letter, finding Roche’s Accutane advertisements to be false and misleading, in addition to being “particularly troublesome.”

FOR MORE ACCUTANE LAWSUIT INFORMATION, PLEASE CONTACT AN ACCUTANE SIDE EFFECTS LAWYER.

When Michigan Rep. Bart Stupak’s son committed suicide while on Accutane, it struck a personal chord, resulting in an aggressive attempt to gain more information on the extent of Accutane side effects. Stupak has not yet taken any individual steps toward an Accutane lawsuit but hopes other Accutane lawsuits will bring more attention to the Accutane side effects to people hearing about the Accutane legal news. Families that have suffered suicide losses linked to Accutane have had similar stories as Stupak in that their children failed to show any signs of depression prior to the suicide act.

A December 11, 2002 hearing on Accutane focused on Accutane birth defects, depression, and 173 suicides. The SMART program was designed to prevent birth defects from occurring with women using Accutane. Roche claimed that only 2,300 pregnancies have occurred since Accutane’s entrance to the market, however Stupak has found that according to a 1990 Roche Accutane report it indicated in a three-month period alone during 1999 there were 93 unwanted pregnancies reported and 42 abortions occurred.

A 1990 FDA report stated 11,000 to 13,000 Accutane Accutane related abortions and 900-1,1000 Accutane birth defects had been suffered. In 2001, reports indicated that women were still ill informed of dangers of birth defects and Accutane use and after the SMART program was strengthened at the start of 2002, a national group that tracks prenatal birth defects exposures says reports are showing women are still becoming pregnant while taking Accutane.

While Roche has maintained that there is a lack of scientific evidence showing proof of depression or suicide resulting from the use of Accutane, a 1997 FDA memo indicates Roche agreed with the agency that there was in fact a problem. Roche officials have denied this memo reference. Despite any scientific evidence or not, this does not change the fact that the FDA has confirmed 173 suicides amongst Accutane users since 1982. Based on evidence alone, a medical officer with the FDA back in 1998 stated that it was hard to avoid concluding that Accutane can affect the human brain and is associated to serious psychiatric disorders in some patients.

Due to under reporting, some people fear the actual number of Accutane patients affected by Accutane side effects is much higher. The actual figure of suicides associated to Accutane use could be as high as 20,000, according to an FDA official that says only 1% of suicide adverse events are ever even reported. Now, in addition to links between Accutane and birth defects and psychiatric disorders, reports of possible connections between Accutane and inflammatory bowel disease and lupus have been made as well.

As more Accutane lawsuit news become available following the December 2002 U.S. House of Representatives Energy and Commerce Committee Oversight and Investigation Subcommittee, the future of Accutane will unfold. The number of Accutane lawsuits to be filed and settled will soon tell what type of future Hoffmann-La Roche is in store for.

More Accutane Lawsuit Articles...

October 9, 2003, "Accutane Maker Accused of Contributing to Suicide of Teenage Boy"

May 23, 2003, "Accutane Sparks Worldwide Concern"

FOR MORE ACCUTANE LAWSUIT INFORMATION, PLEASE CONTACT AN ACCUTANE SIDE EFFECTS LAWYER.