April 13, 2009

Raptiva: A Drug for Psoriasis Recalled

Another so called medical advance has been brought to an end.

Raptiva, a once a week injection for Psoriasis will be totally off the US market in June 2009.

Psoriasis is a common, incurable, non-contagious, autoimmune disease
where skin cells replicate to quickly. The body produces new skin cells at about 10 x’s faster than it’s normal rate, but then sloughs then off at the normal or slower rate. When this happens the skin piles up on the surface, becomes red, swollen and often appears patchy looking. Psoriasis can happen anywhere on the body but usually appears on the scalp, elbows, knees, buttocks, or back of the wrist. Psoriasis is know to come and go in cycles.

Raptiva was approved by the FDA in 2003 after what I personally would call a short trial. The trial was 24 weeks long and involved 2700 people.
At that time it was reported that: “Raptiva was well tolerated in Phase III studies. Adverse events that occurred in at least five percent of patients treated with Raptiva and one percent more frequently than in the placebo group included headache, chills, pain, flu syndrome, fever, asthenia, nausea myalgia (muscle pain) , and pharyngitis. Five of these events (headache, chills, fever, nausea and myalgia) were predominantly acute adverse events, principally seen following the first two injections of Raptiva. For the third and subsequent doses, the incidence of acute adverse events was similar between the Raptiva and placebo groups. Less than three percent of patients were discontinued from treatment due to adverse events. Infrequent serious adverse events included psoriatic recurrences (most of which occurred after treatment was stopped)and Thrombocytopenia”

Raptiva was designed to selectively and reversibly block the activation of T-cells that cause psoriasis or what you might call, suppresses the immune system.

Now, I’m no genius but I would think that in this day and age when our immune systems need all the help they can get to stay healthy from toxin, chemicals, radiation, etc. that maybe there could be a better way to treat Psoriasis.

Here’s a little history.
October 2008: FDA updates it’s warning label for Raptiva and it got the “Black Box” warning
December 2008: US sales for Raptiva were reported at 108 million in it’s last full year on the market.
February 19th 2009: The use of Raptiva should be suspended in the European Union
February 21st 2009: The marketing of Raptiva in Canada was suspended.
March 2009: FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML (progressive multifocal leukoencephalopathy)
April 2009: Manufacturer does voluntary drug withdrawal and sends out “Dear Doctor Letters”
June 2009: Drug off the market for good in the US.

Now a website called Defective Drugs reports;
Despite being an effective psoriasis treatment, Raptiva is known to have some severe, potentially fatal side effects including:
• Bacterial sepsis, an infection of the blood
• Lymphoma, a cancer affecting the lymph nodes (the glands located throughout the body that filter bacteria and malignant cells from the body)
• Progressive multifocal leukoencephalopathy (PML), swelling of the brain's white matter
• Viral meningitis, an infection that results in brain and spinal cord inflammation.
While some of these Raptiva side effects, such as lymphoma, are incurable, all are life threatening and will result in death without immediate medical care.
Raptiva patients should seek emergency medical attention, should they develop any of the following symptoms of Raptiva drug infections:
• burning or difficult urination
• chills
• congestion
• coughing
• fever
• pain
• redness
• sore throat
• swelling

Since 2003 it is reported that approximately 46,000 people have been treated with Raptiva and that at the time of recall 2,000 patients in the US are still receiving this treatment.
Guess once again the guinea pigs have proved Big Pharma and the FDA wrong.

Here are some alternative recommendations for people that suffer from Psoriasis that have NOT been shown to provide any of the above side effects.
* Increase fiber intake.
* Increase Fatty acids which have been shown to reduce inflammation and improve symptoms of Psoriasis.
* Many people have been found to be deficient in Zink and Vitamin A (pumpkin seeds contain Zink, and orange, yellow and green vegetables contain vitamin A)
* Increase water intake to help flush toxins and reduce inflammation
* People with Psoriasis have been found to have difficulty digesting protein so one may need to avoid red meat, poultry and dairy products.
* Avoid other foods that are hard to digest such as fatty, fried and refined sugars.
* Alcohol can cause inflammation and trigger flare-ups.
* Flaxseed and Fish oil supplements have been shown to reduce symptoms
* Digestive Enzymes with each meal can help with digestion
* Milk thistle to help with liver detox

Now if you, someone you know or love has been on, or is on Raptiva please check out Defective Drugs and contact a Raptiva attorney. One day the FDA may learn that drugs are not the best way to go.

2 comments:

  1. Wow! You did do your research. Great job!

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  2. More than 4.5 million adults in the United States have been diagnosed with psoriasis, and approximately 150,000 new cases are diagnosed each year. An estimated 20% have moderate to severe psoriasis. Psoriasis occurs about equally in males and females. Recent studies show that there may be an ethnic link. It seems that psoriasis is most common in Caucasians and slightly less common in African Americans. Worldwide, psoriasis is most common in Scandinavia and other parts of northern Europe. It appears to be far less common among Asians and is rare in Native Americans.
    http://www.botanical-source.com

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