Accutane has been linked to suicide, depression, severe birth defects, and damage to the liver, kidneys, and colon. Other side effects include headaches, nausea, vomiting, bone and muscle problems, blurred vision, hearing problems, dizziness, mood changes, severe stomach pain, diarrhea, rectal bleeding, lipids or fats and cholesterol in blood problems, allergic reactions, dryness of the eyes, yellowing of the skin or eyes and dark urine.

• Suicide Depression Warning: The link between Accutane and possible suicide was brought to light when U.S. Rep. Bart Stupak of Michigan held a news conference about Accutane. Congressman Stupak’s 17-year-old son committed suicide after taking Accutane. Congressman Stupak’s son was a popular athlete and president of the student council. He showed no signs of depression until taking Accutane.

Accutane may cause depression, psychosis and an obsession on suicidal thoughts. People taking Accutane have a higher than normal rate of suicide attempts, suicide, and aggressive or violent behavior. Symptoms often continue after treatment has ended.

Many parents of teenagers taking Accutane have reported serious depression and mood changes in their children while taking Accutane. The manufacturer believes there is no evidence showing Accutane is responsible for feelings of depression or suicidal tendencies, but the death toll has continued to rise despite this. Since 1982, there have been 142 suicides involving Accutane.

• Birth Defects: Birth defects associated with this medication are so severe that women who become pregnant while using the drug are routinely advised by their doctors to have an abortion.

Accutane presents such a high risk during pregnancy that the FDA now requires all female users to enroll in a national registry called iPLEDGE and sign a form stating they know of the drug’s risks. These risk include mental retardation and severe brain and heart defects in babies. Doctors are required to perform pregnancy tests on women before prescribing Accutane and then re-test them each month thereafter. They also must agree to use at least two forms of birth control while taking Accutane.

• Brain problems: Accutane can cause increased pressure on the brain, a condition known as pseudotumor cerebri. Early signs and symptoms of pseudotumor cerebri include swelling around the optic nerve, headache, nausea and vomiting, and visual disturbances.

• Organ and system failure: There have been reports of internal organ damage and systems failures as a result of using Accutane. These include damage to the colon, liver, kidney, central nervous system, gastrointestinal tract, cardiovascular system, skeletal system, bone density, eyes, hearing and skin.

• FDA Warnings: In August 2005 the FDA enacted guidelines seeking to ensure pregnant women do not use the medication and revised Accutane labeling to warn against the symptoms of depression and suicidal tendencies.

The FDA labeling revision for the drug states in part: "All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary."

The FDA has required that doctors and patients sign a lengthy consent form prior to beginning Accutane therapy acknowledging they have been informed of the dangers.

Accutane is the brand name for the drug "isotretinion". There is no generic version of Accutane available.

All isotretinoin sold in the United States is sold as Accutane. The medication belongs to a class of drugs known as retinoid medications. Retinoid medications are related chemically to Vitamin A. Many of the Accutane side effects resemble Vitamin A overdose.

Accutane works by reducing sebaceous gland function. The sebaceous gland is made up of multiple lobes and it produces sebum. Sebum is an oily substance. The reduction of sebum secretion is temporary and depends on the dose and duration of treatment. Accutane treatment usually lasts for 15 to 20 weeks. In many cases, Accutane results in a complete or prolonged acne remission.