The Food and Drug Administration has warned about an increased risk of life-threatening blood clots or a severe narrowing of the arteries associated with the leukemia chemotherapy drug Iclusig (ponatinib). Based on these findings, Ariad Pharmaceuticals was forced by the FDA to suspend sales of Iclusig until new safety measures could be put into place that would help to limit the risk of complications from the drug.
According to the FDA warning:
Iclusig is a prescription medicine used to treat adults diagnosed with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), who are no longer benefiting from previous treatment or who did not tolerate other treatment.
The FDA began to raise concerns about the safety of Iclusig after clinical trial data revealed that 8% of patients who were taking the drug experienced serious blood clots in their arteries. Studies also found that 3% of patients who were prescribed the leukemia drug suffered severe blood clots in their veins. Additional clinical trial data revealed that 20% of Iclusig patients—or one out of every five patients taking the drug—experienced blood clots or narrowing of blood vessels.
Acting on this data, in October 2013 the FDA ordered Ariad to stop selling or marketing Iclusig until safety measures could be put into place that would help to limit the blood clot risk associated with the drug. These safety measures included a new label warning about the risk of blood clots and narrowing of the arteries that have been associated with the drug. The FDA also required Ariad to conduct additional research in order to study the risk of side effects associated with Iclusig.
The FDA warning advised patients taking Iclusig to seek immediate medical attention if they experience any symptoms which may be a sign that they are having a heart attack, including:
- chest pain or chest pressure
- pain in the arms, back, neck, or jaw
- shortness of breath
The agency also advised Iclusig patients to seek medical attention if they experience signs of a stroke, such as:
- numbness or weakness on one side of the body
- trouble talking
- severe headache
Heygood, Orr & Pearson fights for patients hurt by dangerous drugs
Despite the best efforts of the FDA and other health organizations, tens of thousands of patients are serious injured each year by dangerous drugs or medical devices. Sadly, many of these cases could have been prevented if the manufacturers of these goods had designed and developed their products to meet safety standards that are mandated by federal law.
The attorneys at the law firm of Heygood, Orr & Pearson have based our careers on the goal of holding companies who manufacture defective drugs or medical devices accountable for the injuries caused by their products. Our firms has secured verdicts and settlements for our clients totaling more than $200 million—including more than $50 million in 2010 alone.
If you or a loved one has been injured by a drug, medical device, or other product, you deserve answers about why these injuries occurred and how they could have been prevented. If these injuries were the result of a defective drug or even a doctor’s negligence, you have the right to demand that the negligent party be held responsible.
For a free legal consultation about your case and to speak with a lawyer about whether you may qualify to file a lawsuit, contact the law firm of Heygood, Orr & Pearson so that we can help you determine the best way to protect your legal rights and interests. You can reach us by calling our toll-free hotline at 1-877-446-9001, or by following the link to our free case evaluation form.