A class action lawsuit has been filed against ARIAD Pharmaceuticals, Inc., and some of its officers alleging the company did not adequately list potentially deadly side effects on the label of its leukemia drug Iclusig (ponatinib).
In December 2011, ARIAD announced preliminary clinical data that showed “strong clinical evidence of the anti-leukemic activity of ponatinib.” The company went on to tout the “favorable safety and tolerability profile of ponatinib.” The drug won approval for marketing in the United States by the Food and Drug Administration (FDA) based on that data the following year.
However, on Oct. 9, 2013, ARIAD updated its safety label based on data from the same clinical trial, revealing a higher rate of blood clots and heart-related side effects than previously reported. The company also disclosed that serious arterial thrombosis occurred in nearly 12 percent of patients treated with the drug during a two-year period, and that 6.2 percent of the patients had strokes.
Earlier this month, upon the FDA’s urging, ARIAD announced it was suspending sales of the drug because of a greater risk for blood clots. The agency has also halted enrollment of patients in new studies and will end a late-stage trial currently in progress.
Ponatinib was approved to treat two rare types of leukemia, chronic myeloid leukemia and acute myeloid leukemia. About 5,000 people are diagnosed with chronic myeloid leukemia each year.
The class action lawsuit against ARIAD seeks to recover damages against the company and certain officers as a result of alleged violations of the federal securities laws.