Tysabri Clinical Trials Halted For Rheumatoid Arthritis
There has been a lot of controversy about the Multiple Sclerosis drug Tysabri since it was first approved by the Food and Drug Administration (FDA) in November, 2004. Patients were convinced they’d found a miracle drug, and Tysabri was being tested for effectiveness in treating Crohn’s disease. Then, three months from the date of its release it was suddenly pulled from the marketplace. It was a crushing blow for MS patients who were finally finding relief from their condition.
Why was Tysabri Taken Off the Market?
No one knew what to think. The story was withheld from the public for awhile, and then the co-companies who make Tysabri let people know what was going on. During clinical trials, two MS patients and one Crohn’s patient contracted a rare but deadly viral infection of the brain known as multifocal leukoencophalopathy (PML). One of the MS patients and the Crohn’s patient both died from the infection. Therefore, it was necessary to pull the drug from the market for further testing. At the same time, the clinical tests for Crohn’s and rheumatoid arthritis ceased.
The drug manufacturers were almost as puzzled as the patients. Before releasing the drug, it had been tested extensively, and no side effects like this had surfaced. Then they found the answer. The three patients who contracted PML had all been taking another immunosuppressant drug in addition to Tysabri. By combining the two drugs in a patient’s system, his immune system lowered dramatically allowing other diseases to infiltrate his body. It took both drugs used in conjunction to cause this deadly side effect.
Back on the Market Under Strict Regulations
In July, 2006, the FDA allowed the drug back on the market under certain strict conditions. In order to re-release Tysabri, the following regulations had to be complied with:
Patient must have a strong immune system.
Tysabri must be taken without additional immunosuppressant drugs.
No other drug will work for the patient.
Registered infusion centers alone could administer Tysabri.
Doctors must enroll in the TOUCH program in order to prescribe Tysabri.
There are over 10,000 MS patients worldwide who take Tysabri. PML has not been a problem with any other patient. Patients are thrilled with this drug that can reduce the number of relapses by as much as 67%. Tysabri also has an effectiveness rating twice that of any other MS drug.
The clinical trials were continued testing the effectiveness of Tysabri in the treatment of Crohn’s disease. On January 14, 2008, the FDA approved the use of Tysabri for certain Crohn’s patients. Patients who have moderate to severe cases of Crohn’s in which inflammation is present and who find that other Crohn’s medications don’t help them any more will be allowed to take Tysabri. Unfortunately, the clinical trials regarding rheumatoid arthritis have never been resumed.
The main focus is on Tysabri which should be of great interest. If not then you may be interested in educating yourself on Arthritis. Feel free to drop by our site, anytime. Make a note of our address at MYARTHRITISRELIEFCENTER.COM.
Click the XML Icon Above to Receive Health & Fitness Articles Via RSS!
