FDA Issues Safety Alert on Cancer Drug Iclusig Due to Adverse Events

As reported by Bloomberg News (10/11 Tirrell),  Reuters (10/11, Siddiqui) and  MedPage Today (10/11, Gever), the FDA issued a drug safety alert on Friday for Ariad’s cancer drug Iclusig (ponatinib) after one-fifth of patients in a postmarket clinical trial were found to have developed blood clots and narrowing of blood vessels that puts them at higher risk for heart attacks and strokes.  The notice came after Ariad disclosed on Wednesday that the FDA asked the company to stop enrolling patients in clinical trials of Iclusig.

Iclusig was approved in December 2012 by the FDA for the treatment of adults with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

In its safety announcement, the FDA cautioned, “Health-care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.”

If you would like more information about this safety alert, please feel free to contact us toll-free 888-841-9623 or submit your inquiry online.

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