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You are encouraged to report negative side effects of prescription drugs.
Tysabri-Natalizumab as a treatment for Multiple Sclerosis appears to be more effective
than Interferon in preventing relapses in multiple sclerosis.
Some safety concerns.
The drug has had a roller coaster ride of success and despair for all -
However in February 2006 disaster seemed to strike when two of the trial subjects died of a rare brain disease called Progressive Multifocal Leukoencephalopathy (PML).
Independent researchers reviewed the data from nearly every one of the 3000 subjects.
They were made up of a mixture of MS, rheumatoid arthritis and Crohn's sufferers.
It appeared that the infection had occurred in the two individuals as a result of an interaction with Avonex.
Based on the trial data researchers estimate the risk of developing PML by patients
on Tysabri as 1 in 1000 -
Tysabri has been re-
New patient monitoring and other safety controls will be introduced to limit the risk of PML.
It must be remembered that it will be restricted to the relapse-
Tysabri-
It is licensed for the treatment of very active relapsing – remitting multiple sclerosis in those cases where interferon treatment has failed. There are two areas of controversy surrounding this biogen medication.
1. Claims of a marked reduction of relapse rate in placebo controlled trials depends on interpretation of the data and so hence, long term experience may indicate a more modest benefit than is claimed, moreover it is not clear whether, after a period of time, say two years, of treatment, from what is an expensive medication, disability is ameliorated to any extent.
2. The very nature of the drugs mechanism of action has led to the detection of a small number of cases of Progressive Multifocal Leukoencephalopathy (PML).
This very serious disease of the brain is more likely to occur when taking Tysabri and so regular MRI scanning needs to be undertaken in all such patients.
For this reason the medication is only to be prescribed in major neuroscience centres, by specially experienced neurologists.
The medication is given intravenously once every four weeks, infusion side effects may include nausea, vomiting, fatigue, joint pains, headaches and skin reactions.
Several patients are known to be taking the drug the future of the medication will depend on its performance under independent assessment and its safety record over the coming years.
The European Licensing Agency has approved Tysabri for MS people who have very active relapsing remitting MS or severe relapsing remitting.
Please Note:
Proventus has only had one Tysabri diary story submitted to-
Stopping Tysabri May Worsen MS!
By Amanda Gardner
Health Day Reporter
THURSDAY, Sept. 13 (Health Day News) -
Patients currently taking the drug should not discontinue it without seeking advice, the experts stressed.
"People taking the drugs should talk to a neurologist before," Light continued. "For patients, it just means don't stop taking the drug without talking to your doctor."
The findings were published Sept. 12 in the online edition of Neurology.
Tysabri (natalizumab), a monoclonal antibody, has been placed under a cloud of controversy for some time.
The drug works by attaching itself to white blood cells called lymphocytes and preventing them from entering the brain, where they do damage that causes the disabling symptoms of MS.
Tysabri had also been used to treat Crohn's disease.
But the drug has had a few awkward moments. It first received U.S. Food and Drug Administration approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy.
In June 2006, the FDA allowed the drug to return to the market, but with strict conditions.
According to the new guidelines, Tysabri can only be administered by approved doctors,
at infusion sites and pharmacies that register and comply with a patient-
Feb 2008
Biogen Idec and Elan Corp, the company that manufacture Tysabri have reported some people have suffered liver injury as a side effect after taking the drug which is a treatment for Multiple Sclerosis and Crohn's disease.
Biogen estimates that less than one in 1000 people taking the drug suffered from
serious liver injury, and there are currently around 21,000 people taking the drug
worldwide.
Regulators updated the product's labelling to highlight liver risks in
January 2008, when it was approved for the new use in the intestinal disorder Crohn's
Disease.
The new information instructs doctors to tell patients considering Tysabri about
the potential liver problems.
The company issued a warning to doctors that signs
of liver injury appeared in people as early as six days after first taking Tysabri.
People with signs of liver damage, such as jaundice should see a health care professional
as soon as possible.
Biogen spokeswoman Shannon Altimari said “that the cases of
liver injury have been reversible after people stopped taking the medicine and none
of the patients with liver damage needed a transplant or died from the side effect”.
Continued
