FDA MedWatch - Tysabri (Natalizumab): Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri
Neurological healthcare professionals, patients
FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Information about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has also been added to the drug label. IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient’s condition after return of immune function.
Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases.
FDA Update on Brain Infection Risk with Tysabri
Belief is the psychological state in which an individual holds a proposition or premise to be true. - Wikipedia
National Multiple Sclerosis Society
A recent update on the National Multiple Sclerosis Society Website reports the following dangerous side effects from Tysabri:
The FDA prescribing information about Tysabri includes a black box warning about the risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability. Click here for more.
The National Multiple Sclerosis Society Website does not report any dangerous side effects from Marijuana although it did report some uncomfortable side effects. (many drugs have uncomfortable side effects - so do debilitating diseases such as Multiple Sclerosis).
Update on Tysabri and PML: UPDATED FEBRUARY 5
According to information released by Biogen Idec, as of January 12, 2010, there have been 31 confirmed cases of progressive multifocal leukoencephalopathy (PML, a viral infection of the brain that usually leads to death or severe disability) among people who have used Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) after it became available for prescription in July 2006.
Signs of PML: Typical symptoms associated with PML progress quickly over days to weeks, and can include:
• personality or behavioral changes
• changes in thinking, memory, and orientation leading to confusion
• onset of seizures, clumsiness or progressive weakness on one side of the body
• disturbances of vision
Julie Falco brings hope to Multiple Sclerosis patients. Cannabinoids manage pain and promote repair!
Cannabis can affect neuropathic pain medical marijuana and multiple sclerosis
Multiple Sclerosis and medical marijuana
The National Multiple Sclerosis Society on cannabis aka medical marijuana
Perhaps now that the FDA has changed its guidelines to adhere to the use of Bayesian statistics in medical trials, adverse side effects such as the unfortunate ones these Multiple Sclerosis patients have endured with diminish and the much safer medical marijuana will become a more mainstream treatment.
Politicians should not be permitted to allow their personal beliefs to influence the approval or disapproval of drugs in this country.
Think of it in these terms; If your mother were dying of a debilitating disease and she was suffering from extreme pain and her doctor told you marijuana might help alleviate her pain, would you deprive her of a treatment that might help her? Or even extend her life? Of course not. What right does the government of the United States have to deprive her of that right based upon some politician's belief system?
You might answer that the doctor never recommended it. That is probably true. Here in Pittsburgh if the Doctor works for UPMC and recommends marijuana, they will be fired. Don't for one moment think your doctor will give you an unbiased medical opinion risking his/her job to help you mother. She is only one of many patients.
Also here in Pittsburgh, our long-time and well respected county coroner Cyril Wecht is on record saying that he has never conducted one single autopsy in which marijuana was the cause of death.
As you can see from the Tysabri warning above many Pharmaceuticals are responsible for many deaths. Most have dangerous side effects. Now that the FDA has issued a new guideline to adhere to the use of Bayesian statistics in medical trials, let's hold them accountable. It's high time that our loved ones stop suffering needlessly due to outdated and incorrect personal beliefs. Not to mention those beliefs paid for and supported by pharmaceutical lobbyists.
FDA Issues guidance to help streamline medical device clinical trials
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