Parker Waichman LLP

Mounting Injury Reports Associated with Leukemia Chemotherapy Drug, Iclusig, FDA Says

The U.S. Food and Drug Administration (FDA) is probing mounting injury reports associated with Iclusig (ponatinib), a chemotherapy treatment for leukemia, the agency announced. Injury reports include serious and life threatening blood clots and severe narrowing of blood vessels in both arteries and veins in patients who are being treated with the leukemia chemotherapy drug, […]

inclusig_fda_reportsThe U.S. Food and Drug Administration (FDA) is probing mounting injury reports associated with Iclusig (ponatinib), a chemotherapy treatment for leukemia, the agency announced.

Injury reports include serious and life threatening blood clots and severe narrowing of blood vessels in both arteries and veins in patients who are being treated with the leukemia chemotherapy drug, Iclusig. Data from clinical trials and received from post-market adverse event reporting reveal that significant adverse events have occurred in patients who are treated with Iclusig and include heart attacks that have resulted in death, worsening coronary artery disease, stroke, narrowing of the large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for patients to undergo urgent surgical procedures to restore their blood flow.

The agency announced that is working to continue evaluating adverse events and will advise the public when it obtains more information.

Iclusig is a prescription medicine that is used in the treatment of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), in adults who are not receiving benefits from prior treatment or who were unable to tolerate other treatment.

Iclusig received FDA approval in December 2012. At the time of the drug’s approval, the label contained information concerning blood clot risk. That information was indicated in the Boxed Warning and Warnings and Precautions sections of the label.

In clinical trials that were conducted before to the drug’s approval, serious arterial blood clots were found to have occurred in 8 percent of patients, and blood clots in the veins were reported in 3 percent of patients treated with Iclusig. The most current clinical trial data submitted by Iclusig’s manufacturer to the FDA, indicated that at least 20 percent of all participants treated with Iclusig developed blood clots or narrowing of blood vessels.

Health care professionals should consider individual patient history, according to the FDA, before prescribing Iclusig, and should weigh the risks and benefits for their patients’ Leukemia treatment. Patient who are taking Iclusig are advised to seek immediate medical attention should they experience symptoms of a heart attack—chest pain or pressure; pain in their arms, back, neck or jaw; or shortness of breath—or stroke—numbness or weakness on one side of the body, trouble talking, severe headache, or dizziness.

Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online to www.fda.gov/MedWatch/report.htm, or downloading the form or calling the FDA, toll-free, at 1.800.332.1088, to request a reporting form. The completed form should be sent to the address on the pre-addressed form, or submit the completed form, by fax, to 1.800.FDA.0178.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
They did their job. Thank you great professional highly recommend them
Donald Brown
4 years ago
5 Star Reviews 150
Call back in good timing
Genevalea Lee
a year ago
5 Star Reviews 150
Excellent supportive staff, they fight for you every step of the way.
darleen krimetz
6 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038