FDA Investigates Serious Adverse Events Reported by Patients taking Lukemia Drug Iclusig™
On October 11, 2013, the FDA issued a Drug Safety Communication informing the public that the FDA “is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia chemotherapy drug Iclusig™ (ponatinib).”
According to Reuters, 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. At the time of approval, the drug’s label contained information about the risks of blood clots.
The FDA’s Safety Announcement reported that “[i]n clinical trials conducted before approval of Iclusig™, serious arterial blood clots occurred in 8 percent of Iclusig™-treated patients, while venous blood clots occurred in 3 percent of Iclusig™-treated patients. In the most recent clinical trial data submitted by the manufacturer to FDA, at least 20% of all participants treated with Iclusig™ have developed blood clots or narrowing of blood vessels. Data from clinical trials and postmarket adverse event reports show that serious adverse events have occurred in patients treated with Iclusig™, including heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to restore blood flow. Other problems occurring with the drug’s use include congestive heart failure (CHF) and loss of blood flow to extremities resulting in tissue death requiring amputation. Newly identified serious adverse reactions have also been reported involving the eyes, including decreased vision and clots in blood vessels of the eye. These adverse events were seen in all age groups treated and in those with and without cardiovascular risk factors.”
The FDA recommends that doctors should consider whether the benefits of Iclusig™ exceed the risks of treatment before prescribing Iclusig™. The FDA also recommends that “patients taking Iclusig™ should seek immediate medical attention if they experience symptoms suggesting a heart attack such as chest pain or pressure, pain in their arms, back, neck or jaw, or shortness of breath; or symptoms of a stroke such as numbness or weakness on one side of the body, trouble talking, severe headache, or dizziness.”
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