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The Accutane Drug Lawsuit

Accutane was a powerful drug used in the treatment of severe acne. Commonly used by over two million patients before it was discontinued, it was an effective but not always a safe method to treat severe acne. Some users of Accutane experienced minor side-effects such as dryness, nosebleeds, hair thinning, headaches, and increased sensitivity to light. Other users experienced more severe side-effects such as depression, suicidal thoughts, and Crohn’s disease.

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What is Accutane?

Isotretinoin, which was marketed under the name Accutane, was considered by some as an effective treatment for severe acne. It was considered a drug of last resort when users had not responded to more traditional and safer treatments such as creams and pills. Accutane has been a highly controversial drug over the last decade with the Swiss drugmaker Roche spending millions of dollars defending themselves against lawsuits. Due to the high cost of litigation and the move of generic brands into the market Roche stopped selling Accutane in 2009. Since the discontinuation of the marketing and selling of Accutane generic forms of the drugs have entered the market. Currently, the generic form of the drug isotretinoin is sold under the generic names Claravis, Sotret and Amnesteem. Continued side-effects with the generics also exist. For example, users can still suffer from inflammatory bowel disease, depression and suicide.

What is Accutane used for?

Accutane is the trade name for Isotretinoin which has been used to treat severe acne. Current research is also underway to determine if this drug can be used to treat various cancers, specifically, if it can be used as an anti-cancer chemotherapy drug. The drug is currently being used in research to fight certain skin cancers, cutaneous T-cell lymphoma, acute promyelocytic leukemia, lung cancer, breast cancer, ovarian cancer, bladder cancer, kidney cancer, and head and neck cancers. Unfortunately, there can be serious side-effects with the medication including headaches, hypothyroidism, abnormal lipid levels, dryness, peeling, itching and elevation in liver enzymes.

  • Accutane was introduced to the market in 1982 as a prescription medication to treat severe acne. Since then an estimated 18 million people have been prescribed the drug. Thousands of personal injury claims have been filed with Roche paying out millions of dollars in damages. The drug was discontinued in 2009, but the drug is still sold sold under generic names with strict monitoring on its use.

Accutane Usage and Statistics

Accutane, which is no longer sold by drug giant Hoffmann-La Roche Inc., was sold to over 13 million patients since 1982. By the time Roche announced they were exiting the market sales of the product made up less than 5% of the isotretinoin market. Roche has lost multiple personal injury claims for their product with users arguing they failed to adequately warn the market about the serious side-effects of Accutane, which can include depression, suicide, Crohn’s disease, birth defects, and miscarriage. Now the drug is marketed by other manufacturers under generic prescriptions.

How Accutane Works

Accutane successfully helped many users who had severe acne by reducing the size and amount of oil produced by the skin’s glands. The decrease in oil reduced the amount of acne bacteria, which resides on the skin, and the amount of skin cells reproduced by the skin. Finally, Accutane helped reduce inflammation producing a dramatic decrease in acne within the first month of treatment. Accutane (isotretinoin) is a vitamin A derivative (13-cis-retinoic acid) which is taken by mouth, generally with food. The medication can be taken for up to 20 weeks or at a lower dosage for more than six months. Isotretinoin was first registered in 1979 but not released for use in patients until 1982 when it was marketed as Accutane.

Side Effects of Accutane

  • Increased risk of inflammatory bowel disease
  • Increased risk of Crohn’s disease
  • Increased risk of Ulcerative Colitis
  • Abdominal pain
  • Cramping
  • Fatigue
  • Red cracked lips
  • Intestinal Spasms
  • Nausea
  • Vomiting
  • Diarrhea
  • Diminished night vision
  • Peeling Skin
  • Voice Changes
  • Slow healing of cuts and sores
  • Dry Skin and eyes
  • Cold symptoms
  • Muscle aches

Accutane Medical Studies

It is estimated up to 50 million Americans struggle with acne. In fact, it is considered one of the most common skin disorders in the United States. Unfortunately, it frequently affects teenagers who are more likely to suffer severe psychological difficulties from the skin condition including self-consciousness, embarrassment, depression, low self-confidence, feelings of alienation and social withdrawal. Given the severe social, physical, and emotional implications of severe acne many people are willing to take drastic measures to clear up their skin, even if it means taking a potentially dangerous medication such as Accutane.

Accutane Black Box Warnings

  • Accutane was first prescribed in 1982. Within one year there were negative reports about the drug if used by pregnant women. Between 1984 to 1988 the FDA required the manufacturer of Accutane to send additional information to physicians notifying them of the potential side-effects of the medication. By 1985, after further research and studies were completed, the FDA notified Roche they would need to include a black box warning for Accutane to notify users that the drug could cause fetal deformities and possibly fetal death. Warnings included the following:
  • Severe Birth Defects
  • Abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands
  • Low IQ scores
  • Increased risk of a spontaneous abortion
  • Risk of premature death
  • Increased risk of facial dysmorphia
  • Cleft palate
  • Cerebral abnormalities
  • Cerebellar malformation
  • Thymus gland abnormality
  • Parathyroid hormone deficiency
  • Increased levels of triglycerides and cholesterol
  • Potential liver damage
  • Erectile dysfunction
  • Headaches
  • Brain swelling
  • Seizures
  • Disturbances of the nervous system and Damage to the skin and Mucous membranes.

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