Dangerous drug lawyers at Pintas & Mullins Law Firm confirm that the FDA recently issued a warning to healthcare professionals about the risk of blood clots in patients taking Iclusig (ponatinib). Due to higher than expected reports of life-threatening blood clots and narrowing of blood vessels, the FDA is opening an investigation and recommending physicians reconsider prescribing the drug.
Iclusig is approved for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) or chronic myeloid leukemia (CML) who did not respond to other approved cancer treatments. Its manufacturer, Ariad Pharmaceuticals, recently stopped all of its ongoing clinical trials of Iclusig based on these new findings. Information onclinicaltrials.gov shows that the company was engaging in about 16 clinical trials on Iclusig’s effects on other cancers, such as head, neck and lung.
When Iclusig was approved, in December 2012, it did include a boxed warning about the potential risk of thrombosis (blood clots) as well as liver toxicity. The approval process was accelerated based on a single clinical trial (referred to as the PACE trial) which yielded positive results, however, officials are now quickly backtracking due to reports of very serious side effects.
The accelerated approval program requires drug manufacturers to conduct post-market studies to confirm the drugs’ benefits, efficacy and safety. Analyses and follow-up studies remain in-progress; it was updated clinical data from the PACE trial that the FDA found so worrisome.
In this trial, serious blood clots in the arteries occurred in about 8% of patients, and serious clots in veins occurred in about 3%. The updated data, however, showed that at least 20% of patients treated with Iclusig developed blood clots or serious narrowing of blood vessels.
Narrow blood vessels and blood clots can lead to an array of severe, often fatal health effects, such as heart attack, stroke, and limb amputations. Blood clots can easily break away from their original formation site, traveling to the heart or lungs, resulting in potentially life-threatening clots in those organs. They may also travel to the brain and cause strokes.
Compounding the risk, factors and conditions that aggravate blood clot risk also happen to coincide with many of the conditions cancer patients are subjected to, including: prolonged bed rest, surgery, and certain medications. The FDA was also recently informed of a new, previously undisclosed adverse event associated with Iclusig – ocular (eye) blood vessel clotting, which can cause vision loss. The agency affirmed it would keep the public updated as soon as new information is made available.
In related pharmaceutical news, a widely used HIV drug was recently linked to a significant increase in suicide attempts and thoughts. The drug, Sustiva (efavirenz), is associated without more than double the risk of suicidality, according to four recently-conducted clinical trials. The drug is known for causing neurological side effects, and package inserts do indicate the risk of suicide, however, not at this level.
Researchers concluded that numerous factors helped predict the risk of suicidality in Sustiva patients, such as the use of injection drugs, being under the age of 30, and having previous psychiatric diagnoses. They also noted that there is potential for underreported or undisclosed suicidality in patients. The study was supported by the National Institute of Allergy and Infectious Diseases.
Dangerous drug lawyers at Pintas & Mullins Law Firm have over two decades of experience working with families of loved ones injured by pharmaceuticals. We understand the anxiety and stress that comes with mounting medical bills and adverse drug side effects, and do everything in our power to obtain the maximum amount of compensation for your suffering. Contact one of our skilled drug lawyers today for a free, no-obligation legal consultation.