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ponatinib 6 articles

Ariad Pharmaceuticals adds serious blood clot, heart failure risks to label of leukemia drug

Ariad Pharmaceuticals is re-launching its leukemia drug Iclusig (ponatinib) with new warnings about potential blood clots and the risk of heart failure. The Food and Drug Administration (FDA) ceased sales and promotion of the drug until the drug company addressed safety concerns including the danger of life-threatening blood clots associated with the medication. Iclusig is a treatment for two rare types of leukemia, chronic myeloid leukemia and acute myeloid leukemia. About 5,000 people are diagnosed with the chronic variety of the disease each year. Iclusig was approved by the FDA in late 2012 under the condition that it carry a ... Read More

European drug regulators launch investigation into safety of leukemia drug Iclusig

The European Medicines Agency has launched an in-depth review into potentially life threatening blood clots associated with the leukemia drug Iclusig (ponatinib). The move comes a month after the U.S. Food and Drug Administration (FDA) ordered Ariad Pharmaceuticals to suspend sales of the drug and halted clinical trials on the medication in the United States. Last month, Ariad Pharmaceuticals disclosed data from clinical trails that showed a higher rate of blood clots from Iclusig than what was seen in previous studies. In the new study, 11.8 percent of patients treated with Iclusig suffered a serious blood clot in an artery ... Read More

Class action lawsuit filed against maker of leukemia drug

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 ... Read More

FDA orders sales of leukemia drug Iclusig stopped due to blood clot risk

Less than a year after the Food and Drug Administration (FDA) approved Ariad Pharmaceutical’s leukemia drug Iclusig (ponatinib), the drug company announced it was suspending sales of the drug because of a greater risk for blood clots. Iclusig 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. When the FDA approved the drug late last year, the agency required that the drug’s label include a black box warning for potentially serious side effects including blood clots and liver toxicity. The FDA had ... Read More

FDA investigates life-threatening blood clots associated with leukemia chemotherapy drug

An increasing number of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) in patients taking the leukemia chemotherapy drug Inclusig (Ponatinib) has prompted an investigation by the Food and Drug Administration (FDA). Data from clinical trials and adverse event reports after the drug was approved in December 2012 show that serious health problems have occurred in patients who were treated with Iclusig, including fatal heart attacks, worsening coronary artery disease, narrowing of the large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to ... Read More

FDA approves new leukemia drug but requires black box warning

The drug Iclusig (ponatinib) has been approved by the Food and Drug Administration (FDA) to treat two rare types of leukemia, but regulators are requiring that the drug’s label include a black box warning for potentially serious side effects – blood clots and liver toxicity. Iclusig, made by Ariad Pharmaceuticals Inc., was approved for treatment-resistant chronic myeloid leukemia and for patients with acute lymphoblastic leukemia with a type of chromosome abnormality. Experts say that the boxed warnings should not have a harsh effect on the sales of the drug because physicians treating patients with these conditions are familiar with the ... Read More