10/11/2013 10:49 am ET Updated Jan 23, 2014

Iclusig, Leukemia Drug, Probed By FDA After Reports Of Serious Adverse Events


Oct 11 (Reuters) - The U.S. Food and Drug Administration said it is investigating an increasing number of reports of serious and life-threatening adverse events in patients taking Ariad Pharmaceuticals Inc's leukemia drug, Iclusig.

Ariad's shares fell 7 percent in early trade on Friday.

In a safety notice posted on its website, the regulator advised patients taking Iclusig to seek immediate medical attention if they experience symptoms suggesting a heart attack.

The notice comes after Ariad disclosed on Wednesday that the FDA asked the company to stop enrolling patients in clinical trials of Iclusig. The agency had identified a number of patients who had experienced blood clots and heart damage after taking the drug.

Iclusig was approved by the FDA in December 2012 to treat adults with two rare types of blood cancers - chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. The drug's label contains information about the risks of blood clots.

The company is testing the drug in seven mid-stage studies for lung cancer, thyroid cancer and another form of blood cancer.

The FDA said that the most recent clinical trial data Ariad had submitted showed at least 20 percent of patients developed blood clots or narrowing of blood vessels.

The agency also said it recently received reports showing that patients treated with Iclusig experienced serious eye problems, including decreased vision and clots in blood vessels of the eye. (

Postmarket reports show that Iclusig patients experienced heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain among others, the FDA said.

The company's shares were down 4 percent at $5.18 at 10:20 a.m. ET, recouping from a low of $5.05.

Ariad's stock lost three-quarters of its value on Wednesday to trade at a three-year low. (Reporting by Zeba Siddiqui in Bangalore; Editing by Sriraj Kalluvila)

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