Swiss pharmaceutical giant Roche has been creating a lot of heat for a lot of mid-level bureaucrats in the United States and Europe over the serious side effects of the company’s popular acne drug Accutane (isotretinon), and frankly, they don’t appreciate it.
The European Medicines Agency (EMA) was blasted today for recent decisions related to Accutane which some medical experts said were questionable. The Lancet Medical Journal, one of the world’s leading medical journals, called for greater transparency and challenged the way the watchdog made some of its licensing decisions. This type of criticism mirrors attacks currently being leveled upon the U.S. Food and Drug Administration (FDA).
The report said, “A complaint had been submitted by Liam Grant from Dublin, Ireland, whose son had committed suicide in 1997. On April 22, 2008, Grant asked EMA for reports on suspected serious adverse reactions to the drug, those which might cause death or life-threatening illness, require admission to hospital or prolongation of hospital stay, or result in persistent or substantial disability or incapacity, congenital anomalies, or birth defects.”
In November, 2004 an FDA researcher went as far as to say that Accutane was one of five drugs that should be studied for potential withdrawal from the market. Moreover, since the late 1990s Accutane’s label has warned that adverse reactions reported by some users include “depression, psychosis, and, rarely, suicidal ideation, suicide attempts and suicide.”
The EMA has argued that the European transparency rules did not apply to serious adverse reaction reports, but the European Ombudsman Nikiforos Diamandouros recently called on the agency to reconsider. The EMA said it would give its response to the Ombudsman by July 31 of this year.
“Citizens of EU member states should welcome and support transparency initiatives within EMA, which might bring about more openness on licensing decisions and suspected adverse reactions,” the Lancet said.
This transparency is also a problem in the United States, particularly as related to the side effects of Crohn’s Disease and other debilitating bowel diseases also related to the drug.
In a case that was settled out of court recently by Roche, a New Jersey man had to have his colon removed as result of the side effects of Accutane. The lawsuit alleged that Accutane gave him a severe inflammatory bowel disorder. After heated legal negotiation the man was awarded $25 million in damages.
The man is not the first to have had his colon removed because of Accutane and this verdict could lead to further settlements.
What is Accutane?
Accutane (isotretinon) was first produced in the ‘60s as a supplementary drug to accompany chemo therapy treatments for in-operative brain and pancreatic cancer and it is still used in that capacity, but then, scientists and doctors found that their patients had amazingly clear skin. Some analysis was done and the FDA approved Accutane in 1982 for use in treatment of severe acne.
Everyone gets some form of mild acne, but Accutane is powerful so it is only used against severe cases with large painful nodules on the body that were unresponsive to conventional therapy, including antibiotics. If you’ve known anyone with this problem, cystic acne is disfiguring and painful, causing red cysts and deep nodules that can leave deep scars.
But as painful as severe acne is, it does not compare the debilitating side effects the drug can cause in some patients such as Crohn’s Disease, an incurable and debilitating bowel disease that considerably lowers the patient’s ability to move and their overall life expectancy.
Accutane is generally a 6 month drug 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 their acne actually increasing during the treatment. Generally their bodies return back to normal between a month to two months after treatment with no signs of serious acne.
Accutane Side Effects
The side effects are numerous. The most debilitating have proven to be the psychological effects and the effects on the bowels. Patient testimony has said that depression and suicidal thoughts are part of their experience. In other cases there have been reports of serious bowel issues.
Some of the side effects are:
- Severe depression
- Suicidal thoughts – The FDA has voiced their concern over the severity of the psychological effects.
- Behavior Changes
- Birth defects
- Crohn’s Disease – An incurable severe bowel disease that also attacks the immune system.
- Inflammatory Bowel Disease – Debilitating and painful bowel problems
- Ulcerative colitis – Requires surgery that could result in a catheter
- Severe Liver Damage – loss of appetite, weight loss, and jaundice (yellowing of the eyes or skin)
Accutane and Crohn’s Disease have been connected and have shown to cause inflammation of the lining of your digestive tract, which can lead to abdominal pain, severe diarrhea and even malnutrition. Crohn’s disease can be both painful and debilitating and sometimes may lead to life-threatening complications.
Accutane and Ulcerative Colitis also have shown to have a connection. that causes chronic inflammation of the digestive tract, is characterized by abdominal pain and diarrhea, not a good symptom for a drug that causes severe dehydration. The aliment affects only the innermost lining of your large intestine and rectum. Ulcerative colitis can also cause loss of work-time and has been known to lead to other life-threatening complications.
Accutane and Inflammatory Bowel Disease can result in a lot of acute pain as the small and large intestine become inflamed and tender making it hard to digest. The lining of the intestine my perforate as a result and may lead to an increased chance of contracting colon cancer.
Accutane Lawyers
The most serious effect of Accutane has been on those who have committed suicide or the loved ones, such as Liam Grant, who have had to live with the pain of loss of a loved one who just wanted to eliminate their acne. But the psychological effects of depression can cause a previously outgoing person to lose friends, relationships, and even lose career advancement opportunities as a result.
The effects of Accutane on the bowels is obvious. The changing diets, painful bowel movements, debilitating stomach pain, and prohibited movement can have a major effect on the patient’s ability to make a living, particularly if the are in a physically challenging occupation.
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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