| FDA panel recommends MS Drug Comeback |
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Almost a year after the contoversial drug, Tysabri was taken off the shelves, the Food and Drug Administration panel has recommended the drug comeback, but not without the list of precautionary measures. The drug is effective against Multiple Sclerosis(MS).
In addition to putting the restrictions, the panel also advised creation of an elaborate system to monitor patients for any side effects of the drug.
The said drug manufactured by Biogen is about twice as effective at treating MS as the drugs now on the market, but its long-term risks and benefits remain unknown. Scientists at the National Institutes of Health have determined that patients who take the drug have about a 1-in-1,000 chance of developing progressive multifocal leukoencephalopathy.
"It is likely there will be cases of PML, and likely we are going to see deaths," said the advisory panel’s chairman, Dr. Karl Kieburtz, a professor of neurology at the University of Rochester. "The point is, is there a reasonable balance that physicians and patients can reach together? The answer is yes, with some restrictions."
"We are pleased that Tysabri will be back on the market," said Dr. John Richert, vice president for research and clinical programs at the National Multiple Sclerosis Society, assuming final FDA approval is forthcoming. "The FDA has been very sensitive in finding a balance between safety and efficacy."
Dr. Robert Temple, director of the FDA’s Office of Drug Evaluation, said the recommendations included a detailed risk management plan. Patients would have to register to receive the drug and sign a monthly checklist to review risks. Patient information would be made available to the company, and ongoing risk assessment would be mandatory.
A day after the panel recommended the drug comeback, Biogen shares closed up $2.03, or 4.5%, to $47.54 Thursday.
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| Marital Rows are harmful to Heart - Mar 4, 2006 19:15 IST |
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A recent study says men can experience hardening of heart arteries due to marital fights with their partners in which either of them try to dominate each other. Woman on the other hand can have similar symptoms if their husbands show hostility during fights.
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