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Accutane® is a potent anti-acne medication that was approved by the U.S. Food and Drug Administration (FDA) in 1982 and recalled by the manufacturer in June 2009. The medication has been linked to severe health risks including inflammatory bowel disease, Crohn’s disease and more.

Accutane® Statistics FDA

• Reuters quotes study results reported in the March 30, 2010, issue of American Journal of Gastroenterology that patients taking Accutane® were four times more likely than non-users of the drug to develop ulcerative colitis within a year.
• Between 1997 and 2002, the Food and Drug Administration (FDA) received reports of 83 cases of inflammatory bowel disease among users of isotretinoin (Accutane®)
• Researchers found a relationship between dosage and the risk of getting ulcerative colitis; the higher the dose of the drug the greater the risk of the disease
• The study was based on reports from 87 health insurance companies about the occurrence of disease. Of 8,189 cases in the study population:
• 3,664 had Crohn’s disease
• 4,428 had ulcerative colitis
• 97 had unspecified bowel disease

A total of 24 cases and 36 controls were exposed to Accutane®. Ulcerative colitis was strongly associated with previous exposure to isotretinoin with an odds ratio of 4.36. Yet, no apparent association was found between isotretinoin and Crohn’s disease. When comparing users and non-users of isotretinoin, the risk of getting ulcerative colitis was greatest in users on the drug for longer than two months.

The researchers said that although the risk of any one person taking Accutane® and developing ulcerative colitis was relatively small, doctors and their patients should be aware of the association.

Psychiatric Disorders

Because of an occurrence of psychiatric disorders, including severe depression, aggressive behavior, psychosis, suicidal thoughts, and actual suicides in patients taking Accutane®, the FDA and the drug manufacturer developed a brochure for prescribes of the medication. The brochure is referred to in the WARNING section of the label inserted in the box with the medication. The brochure’s title is Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane (isotretinoin).

Severe Birth Defects

Accutane® is also known to cause severe birth defects and should not be taken by anyone who is pregnant, intends to become pregnant, or might unintentionally become pregnant. Breastfeeding mothers also should not take the medication. Women of childbearing age pledge to use two forms of birth control while using the medication.

The drug is known to cause severe fetal deformities, miscarriages, death of the fetus and premature births.

Other Side Effects

Other Accutane® side effects that have been associated with include:

• Skin problems
• Stomach problems
• Bone and muscle problems
• Joint pain
• Broken bones
• Hearing and vision problems
• High levels of fat and cholesterol in the blood
• Serious allergic reactions
• Blood sugar problems including diabetes
• Decreased red and white blood cells

Because of its potential side effects, the FDA warns consumers not to order any form of isotretinoin on the Internet.

Ask an Accutane® Lawyer

If you or someone you love has suffered side effects from this powerful drug, you should seek the advice of an Accutane® lawyer. These attorneys are specialists in helping people receive just compensation for their pain, suffering, illness and expense. Contact us for more information.

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The side effects that are associated with Accutane® are relatively well known, but less attention is typically paid to generic versions of the drug that use the ...

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"Dosage size of Accutane® affects side effects"

A recent study has found that the adverse side effects associated with isotretinoin, the active ingredient in Accutane®, may be reduced if the patient takes smal...

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"Research shows Accutane increases risk of ulcerative colitis"

A recent study published the American Journal of Gastroenterology, isotretinoin, whose brand name is Accutane, can cause a number of inflammatory bowel diseases.

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