Accutane is a prescription drug, and is a powerful derivative of vitamin A. Accutane also goes under the generic name isotretinoin, but also goes by: the following brand names:

  • Accutane
  • Sotret
  • Claravis
  • Amnesteem

The Switzerland-based company, Roche Pharmaceuticals, manufactures Accutane. It was introduced to the United States market in the early 1980s. The drug carries a warning that women who are pregnant, or are planning on becoming pregnant while taking Accutane should not use it.

Accutane can cause life-threatening and debilitating birth defects. The danger that this drug poses to the developing fetus is devastating. Women who plan on using the drug must first sign an agreement that they will use at least two separate birth control methods while using Accutane. It is also mandatory for these women to take regular pregnancy tests before, during, and after use of isotretinoin.

A considerable amount of other precautions must be followed while using the drug. Patients taking Accutane must have regular blood and liver function tests to make sure the drug is not causing any serious health issues. Patients should not take any supplements that contain vitamin A while taking Accutane. Patients must protect their skin from sunlight, and should avoid using tanning beds and sun lamps. Also, certain prescription drugs are known to interact negatively with Accutane.

Accutane is prescribed to patients to treat severe nodular acne that does not respond to other acne treatments such as topical ointments or antibiotics. The drug reduces the amount of oil that is produced by the skin and causes a quicker regeneration of skin cells.
The drug is highly effective at treating severe acne, but it does have a long list of negative side effects. Accutane negatively affects various organs and systems within the human body. These include:

  • The nervous system
  • Blood
  • Liver
  • Cardiovascular system
  • Respiratory system
  • Immune system
  • Kidneys
  • Gastrointestinal system
  • Skin
  • Eyes
  • Musculoskeletal
  • Metabolic System

Accutane has also been suggested to have negative side effects for psychiatric health. Depression, suicidal thoughts, and suicide attempts are alleged. By 2005, 190 cases of suicide were linked to Accutane use.

The list of side effects is seemingly endless. Some of the commonly reported side effects are as follows:

  • Dry, flakey, or scaly skin
  • Skin rashes and infections
  • Dry mucous membranes
  • Joint and bone pain

Some less commonly reported, but more serious, side effects of Accutane are:

  • Inflammatory bowel disease
  • Depression and mood swings
  • Impaired vision
  • Rectal bleeding
  • Allergies and hypersensitivity
  •  Lupus
  • Brain swelling
  • Psychosis

Juries have awarded millions of dollars to claimants who alleged that Roche Pharmaceuticals failed to provide warnings for the drug’s side effects. In these cases attorneys were able to prove beyond any reasonable doubt that Roche Pharmaceuticals failed in their line of care, and this failure directly resulted in pharmaceutical deaths or injuries. Drug makers have the responsibility to disclose all known side effects without misleading the patient.

Pharmaceutical manufacturers must also disclose any information about all known side effects to the Food and Drug Administration, even after the drug was granted approval by the FDA.

The FDA has become aware of the potential risks to patients who choose to use Accutane. In 1997, the FDA found out that French health officials requested that Roche Pharmaceuticals place a black box warning on Accutane. The manufacturers did not disclose this information to the FDA; however, a black box warning was applied to Accutane in the United States.

Roche Pharmaceuticals has so far been ordered to pay over $53 million to patients who were injured by Accutane. The manufacturers continue to appeal verdict, although more and more lawsuits are being filed. There are currently no class action lawsuits against Accutane; however, victims can either seek compensation through individual cases or mass torts. Roche Pharmaceuticals removed Accutane from United States markets, but isotretinoin is still available under several generic names.

If you or anyone you know has been injured by Accutane or any of its generic forms, call the law offices of John Michael Bailey right away.


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