FDA asks Ariad Pharmaceuticals to suspend sales, marketing of Iclusig amid side-effect concerns

FDA finds increased frequency of potentially fatal cardiovascular side effects in patients taking leukemia drug

SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

The FDA issued a notification concerning the drug Iclusig (ponatinib), saying it had found an increased frequency of life-threatening blood clots and severe narrowing of blood vessels in patients taking the drug since its December 2012 approval. Patients taking the drug should discuss with their providers the risks and benefits of continuing treatment with it.

"We will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks," FDA Division of Drug Information pharmacist Sadhna Khatri said in a podcast on the FDA website.

The agency said Ariad had agreed to the request and recommended that patients taking Iclusig and not responding stop taking it and discuss alternative treatment options; that patients taking the drug and responding discuss it with their providers; and that prescribers not start treating new patients with it unless there are no other treatment options available and all other therapies have failed.


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