48% Of Patients Taking Iclusig Experience Life-Threatening AttacksPublished: Nov 01, 2013 in Defective Products, Medical Malpractice
A Pharmaceutical product, taken to market with limited testing and time spent monitoring the long-term effects on its usage, may inadvertently cause extensive injury or death to patients, says Alabama product liability attorney Keith T. Belt.
The Ariad Pharmaceuticals to suspend marketing and sales of Iclusig (ponatinib), a chemotherapy agent used to treat leukemia, pending further investigation of reports of a link between the drug and increased risk of “life-threatening blood clots and severe narrowing of blood vessels”.
The FDA issued a warning about the risk on Oct. 11 and today they said:
- Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment.
- Patients who are currently taking Iclusig, who are responding to the drug, and whose healthcare professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues.
- Healthcare professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed.
The agency said roughly 24% of patients enrolled in a phase II trial of the drug and 48% of patients in a phase I study “have experienced serious adverse vascular events, including fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart, and brain requiring urgent surgical procedures to restore blood flow. In addition, the FDA has been informed of an entirely new adverse vascular event with the drug, clotting in ocular blood vessels.
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If you or a loved one has been seriously hurt by a bad drug, give our Alabama product liability lawyers from Belt & Bruner a call today. With offices in Birmingham, Mobile, Huntsville, and Montgomery, our attorneys will travel anywhere across the state of Alabama to investigate the details of your case and may be able to help you obtain compensation for your damages.