Accutane Adverse Effects Consumer Alert

Is Accutane a Miracle Drug to Combat Acne?

Accutane® (isotretinoin or roaccutane) is one of the most potent, effective weapons against severe, disfiguring acne that dermatologists prescribe. Accutane is a synthetic derivative of Vitamin A and works by reducing oil production in the skin. It has been described as "miraculous" by patients who have suffered painful breakouts of severe cystic acne and whose prior conventional treatments were unsuccessful.

First introduced in 1982 by the US drug manufacturer Hoffman-La Roche, Accutane became one of their top sellers with an estimated 1.2 billion dollars in annual sales. Hoffman La Roche, part of the international conglomerate known as the La Roche Group, is estimated to be one of the seven largest drug manufacturers in the world.

What side effects are associated with Accutane?

Accutane is one of the top 3 drugs sold in the US with the most reports of adverse side effects. Serious side effects include:

• Depression, suicidal thoughts, and suicide attempts
• Inflammatory bowel disease (IBS), ulcerative colitis, Crohn's Disease, and rectal bleeding
• Clinical hepatitis and liver damage
• Spontaneous osteoporosis and decrease in bone density
• Bone fractures and delayed healing of bone fractures
• Muscle weakness
• Decreased night vision
• Temporary or permanent hearing loss
• Temporary high cholesterol
• Severe allergic reactions
• Miscarriages, birth defects, premature births, and deaths in babies whose mothers took Accutane while pregnant

Less serious side effects include:

• Sensitivity to sunlight
• Headaches
• Chapped lips
• Nose bleeds due to dry nasal passages
• Dry skin and dry eyes
• Temporary thinning of hair

Due to the number of adverse effects directly related to Accutane®, the FDA now requires all patients who take Accutane to sign a consent form. Since 1996, pharmacists are required to give patients a medication guide that details the risks associated with taking Accutane. Thalidomide and Mifeprex are the only other drugs that have required a medication guide.

What is the Accutane and Suicide Link?

Accutane® has been shown to contribute to serious mental health issues, including depression and suicide attempts. It was not until May 2000 when Michigan Congressman Bart Stupak's son BJ committed suicide while taking the drug did the general public became aware of the danger. Since then, several important facts have unfolded.

• The FDA first initiated discussions with Roche in 1997 concerning reports of serious psychiatric disorders at which time Roche neglected to disclose that the French equivalent of the FDA had ordered Roche to add "suicide attempt" to the warning label.
• The company was actively marketing Accutane as an effective treatment of severe acne that minimized the negative emotional effects of acne such as depression and low self-esteem. At the same time the FDA was urging Roche to strengthen the warnings detailing the risks of depression, psychosis and suicide.
• In response to a 2007 study showing the link between Accutane and suicide, a spokesman for Roche claimed that more than 13 million patients worldwide had been treated with Accutane and that it had "revolutionized the management of severe acne" and, "unfortunately, severe acne can cause some sufferers to become depressed and can also affect their mood and self esteem. This is why the information provided with Roaccutane carries a warning that some patients may experience mood changes, including an increase in depression."