The short answer is that Accutane (Isotretinoin) is the most powerful acne fighting drug on the market. It is the drug that the most severe acne sufferers go to if they want to clear up their acne once and for all. These patients are usually suffering from what is called “cystic acne,” which involves giant painful cysts full of puss across the whole body concentrated usually on the back, face, chest, and painful groin area.
Accutane is a drug manufactured and developed by a Swiss company Hoffman-LaRoche. It has since gone generic and is now being produced by various other manufacturers, but is still only by prescription and highly regulated by the US Food and Drug Administration (FDA).
Accutane is not intended to be used by the occasional acne sufferer or even those with a constant pimple problem. The reason for this is because of the serious and, what some have alleged, deadly side effects. We will go into the side effects later. First we must fully go into the details of what Accutane is.
What is Accutane?
Isotretinon was first discovered in the ‘60s as a derivative of vitamin A. It was found that the drug kills rapidly diving cells in the body. Thus it was developed as a supplementary drug to accompany chemotherapy treatments for in-operative brain and pancreatic cancer and it is still used in that capacity. Later, after the treatments started, scientists and doctors found that their patients had amazingly clear skin.
Previously to the discovery of vitamin A in the early 20th century, foods high in its content such as liver, carrots, and broccoli were thought to aid skin health. Vitamin A was found to clear blemishes from skin and keep skin healthy. The substance was also found became toxic if too much was taken.
In the late 70’s researchers for Roche found that they could extract isotretinoin and, unlike vitamine A, apply it in large doses with great effect against severe skin conditions such as cystic acne. Roche submitted the drug and their findings to the FDA and in 1982 it was approved for prescription.
Accutane has a 4 to 6 month treatment that is highly invasive to the body as it dries out the skin and essentially the rest of the body. Patients have reported needing large amounts of water and have said that their acne actually increased at times during the treatment. They have also complained of muscle ache and considerable fatigue. Generally their bodies return back to normal between a month to two months after treatment with no signs of serious acne.
Accutane Side Effects
There is a reason why it is only given by prescription and has not yet, like other drugs, been approved for over the counter sale. As stated previously, the drug comes with some very serious side effects beyond merely dry skin and thirst. In fact, the side effects are so severe that patients are required to adhere to strict behavioral standards during treatment and regular check ups. This is stated in the FDA “iPledge” form that all patients must sign.
iPledge – This is a statement that every male and female patient must sign that says that they will protect themselves from pregnancy and sexual contact that could cause pregnancy. Also, it states that every patient must visit the prescribing physician monthly for a blood test to check cholesterol and for pregnancy. The pledge also requires that prescriptions are filled within 7 days of check-up.
Other side effects include:
- Severe Depression – Reclusive and less active behavior. Tiredness and feelings of distance from others.
- Suicidal Thoughts – Psychological effects as associated with suicide and Accutane.
- Behavior Changes – Extreme mood swings and irritability.
- Birth Defects – Women are advised to use extreme caution to avoid pregnancy.
- Crohns Disease – A chronic disease of the digestive system from mouth to anus that can lead to premature aging, eating disorders, and death (see link).
- Inflammatory Bowel Disease (IBD) – Debilitating and painful bowel problems (see link).
- Ulcerative colitis – Requires surgery with long recovery period.
- Severe Liver Damage – loss of appetite, weight loss, and jaundice (yellowing of the eyes or skin)
There has been some dispute over several of these side effects from Roche, particularly over suicide death and the causes of long term bowel problems. These disputes have led to literally thousands of lawsuits from patients trying to convince both the company and the FDA that these side effects truly exist.
Accutane Lawsuits
There have been around 5000 lawsuits already filed from previous Accutane patients who say that Roche did not adequately inform them of the possible hazards related to bowel diseases associated with the drug treatment. So far Roche has been ordered to pay millions of dollars in damages to Accutane users who have developed IBD, including $25 million paid to one man who took Accutane and developed IBD several years later.
Roche has pulled the drug from the American market, but still manufactures and sells it in other countries. Their profit since then has dipped considerably. What was once a $3 billion dollar a year profit making machine is now only a $1 billion a year profit making machine. The reason for this is that Accutane remains, even in generic form, one of the most expensive drug treatments on the market.
If you or someone you know is suffering from the debilitating side effects of Accutane then you need an experienced defective drug attorney on your side that can get you the compensation you deserve. Call Phillips Webster for a free consultation on your legal options.
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