ACCUTANE

Accutane (generic isotretinoin) is a form of synthetic vitamin A used to treat serious forms of cystic acne that will not respond to other treatment. The Accutane claim is that it sometimes permanently clears serious acne after a few months of treatment, while other treatments are only effective as long as they are continued. Accutane decreases the amount of oil (sebum) produced by the oil (sebaceous) glands in the skin and increases the rate at which the skin is renewed.

Accutane is manufactured in the US by Hoffman La Roche, part of “The Roche Group,” a leading international pharmaceutical company with subsidiaries active in 150 countries. Accutane was approved by the FDA (Food and Drug Administration) in June 1982, and by 2000 Hoffman La Roche reported that 5 million people in the US and 12 million worldwide had taken the drug, most of them young adults.

Accutane has been the subject of much controversy and litigation due to serious side effects including severe inflammatory bowel disease, birth defects, suicide, depression, psychiatric disorders, and the potential for violence in patients taking it, as well as a long list of less serious side effects.  Within a year of the FDA’s approval reports began to come in of serious deforming birth defects in children born to women using Accutane. Within 3 years of the FDA approval reports, other alarming side effects, including depression and seizures, began to come in. There were reports of several suicides in patients taking Accutane. Later reports of severe cases of inflammatory bowel disease and pancreatitis were reported.  The FDA has required several increased levels of warnings about side effects and Hoffman La Roche has designed two programs to reduce the number of pregnancies in women using Accutane that were not successful, followed by an equally unsuccessful FDA program.

Patients have reported both inflammatory bowel disease and lupus after using Accutane. Some possible symptoms to watch for are:

• Stomach, chest, or bowel pain
• Rectal bleeding or serious or bloody diarrhea
• Pain or difficulty swallowing
• Increased heartburn
• Yellowing of the skin or eyes
• Dark urine
• Bad headache or dizziness
• Nausea and vomiting
• Joint or muscle pain
• Bone problems
• Hearing loss
• Difficulty breathing
• Fainting
• Increased thirst or urination
• Slurred speech
• Difficulty moving
• Leg swelling
• Increased cholesterol or triglycerides in blood

If you suffer these side effects you should seek medical help immediately. Blood levels of cholesterol and triglycerides should be monitored during treatment with Accutane.

There have also been reports of suicides, suicidal thoughts, and other psychiatric disorders in patients taking Accutane since 1985. The FDA has required stronger warning on several occasions. Symptoms of these problems can include:

• Depression
• Sadness
• Irritability
• Unusual fatigue
• Difficulty concentrating
• Change of sleep patterns
• Loss of appetite
• Suicidal thoughts
• Suicide attempts
• Seizures

Patients taking Accutane should be carefully monitored for these symptoms and should contact a health care provider immediately if they occur.

The harm to infants whose mothers have taken Accutane during the pregnancy or shortly before getting pregnant is so clear that both the manufacturer, Hoffman La Roche, and the FDA (Food and Drug Administration) have worked to create programs to make sure that patients taking the drug do not become pregnant. These efforts have not been successful and both pregnancies and birth defects continue to occur.

At least one study has also linked Accutane to increased levels of tryglycerides, cholesterol, and transaminase. Less serious potential Accutane side effects include:

• Increased risk of sunburn
• Increased risk of scarring
• Decreased night vision

Accutane should not be taken with several kinds of other medications, which might increase the risks of side effects. You should tell your health care providers all the medications and supplements you’re taking before deciding to take Accutane. With all the concerns about birth defects and emphasis on birth control, you should be aware that Accutane may interfere with the effectiveness of birth control pills that do not contain estrogen.

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