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Saturday, December 21, 2013

After Brief Halt, F.D.A. Allows Sales of Drug for Cancer to Resume

After a clamor from some patients and doctors, the Food and Drug Administration announced on Friday that it would allow sales to resume of a leukemia drug that was temporarily withdrawn from the market for causing potentially deadly side effects.
Sales of the drug, Iclusig, from Ariad Pharmaceuticals, were suspended on Oct. 31 after the F.D.A. concluded that the medicine increased the risk of heart attacks, strokes, blindness, amputations and death.
But Ariad and the F.D.A. said the drug could again be marketed, though for a somewhat narrower patient population. There will also be stronger warnings about the side effects. Sales are expected to resume by mid-January, Ariad said.
The suspension of sales of the drug, which is used mainly to treat chronic myeloid leukemia, had set off protests from doctors, patients and patient advocates, who said Iclusig was the only medicine that worked for some people, the only thing keeping them alive.
For such patients, the loss of the drug was “a safety concern of greater magnitude” than the cardiovascular risks, a group of leukemia specialists and patient advocates wrote in a letter to the F.D.A.
One of those specialists, Dr. Michael Mauro of the Memorial Sloan-Kettering Cancer Center in New York, said he was pleased with the outcome.
“This is exactly what I’d hoped they would do, which is to be sensible,” he said. “Although there is risk, there are clearly patients for whom the drug is...
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