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Accutane® (isotretinoin) is a powerful anti-acne medication that its manufacturer recalled in June 2009. The medication, a potent drug for treating nodular or cystic acne, was losing market share and resulting in too many lawsuits brought against the company because of severe Accutane® side-effects, according to its manufacturer, Swiss company Roche Holding AG.

Pregnancy and Accutane®

Accutane® is known to cause severe birth defects when taken by a pregnant mother. The risk of fetal malformations is extremely high.

When Accutane® was on the market, patients of child-bearing age taking the drug were required to be on two forms of birth control, were followed closely by their physicians, and could receive a prescription for only a month’s worth of the drug.

Known birth defects caused by Accutane® include:

• Severe heart defects
• Hydrocephaly (enlargement of the spaces in the brain filled with fluid)
• Microcephaly (small head and brain)
• Extreme mental retardation
• Abnormalities of the eyes and ears
• Other facial abnormalities including cleft lip and palate

As it is now no longer available in prescription form, isotretinoin should not be purchased over the internet or otherwise bought in a generic form, according to the U.S. Food and Drug Administration (FDA). Patients wanting to take the anti-acne medication in a generic form should be under a doctor’s vigilant care.

Accutane® Long-Term Use

In February 2010 a jury ordered the medication’s Swiss manufacturer to pay an Accutane® patient $25.16 million in damages. Accutane® was blamed for his inflammatory bowel disease that resulted in five surgeries, including one to remove his bowel.

Roche had to pay out $56 million in awards for six cases. The company lost every case except one, in which the verdict was overturned by a Florida appeals court. The claimants all said that the manufacturer failed to adequately warn patients of the potential severe side effects of the drug.

The company is handling nearly 1,000 other lawsuits for damage caused by Accutane®.

Other serious side effects associated with Accutane® have included:

• Depression, thoughts of suicide, and death
• Aggression and violent behavior
• Seizures
• Severe headaches
• Strokes
• Ischemic colitis
• Systemic lupus erythematosus
• Irritable bowel syndrome
• Ulcerative colitis
• Problems of the bones, muscles, joints and ligaments
• Back pain
• Autoimmune disease

If you’ve experienced a long term side effect of Accutane®, our Accutane® attorneys can help you seek compensation for the damage incurred and the challenges you face. For more information or to schedule a free and private discussion of your case, contact us today.

"Generic versions of Accutane® carry similar risks"

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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