FDA Places Partial Hold on Iclusig Clinical Trials
Ariad Pharmaceuticals’ stock fell Wednesday as the U.S. Food and Drug Administration placed a partial hold on clinical trials for the company's drug Iclusig following reports of patients suffering from blood clots and heart damage.
About the Iclusig Clinical Trials
- According to Reuters, Iclusig (ponatinib) is a medication used to treat two forms of blood cancer: chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
- The drug was approved for treatment of these cancers in December with a label warning of blood clots and liver toxicity.
- Iclusig is currently being tested in seven clinical trials as a possible lung cancer treatment.
Complications in Iclusig Clinical Trials
- The FDA has placed a partial hold on the clinical trials due to adverse events leading to Ariad’s shares to fall by 77 percent.
- It has been reported that 12 patients developed blood clots in their arteries after 24 months of treatment with Iclusig.
- Additionally, 6.2 percent of patients experienced heart damage.
According to Drug Information Online other side effects of Iclusig include:
- chest pains
- severe pains in upper stomach and lower back
- high blood pressure
- irregular heart rate
- difficulty breathing
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