An Overview of Iclusig and the Recent Suspension of Sales
A recent suspension of sales of the drug Iclusig, used in the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, may have a ripple effect in the future. A paper slated to be published in the New England Journal of Medicine on November 7th regarding the Phase II Iclusig Pace trial reportedly now requires modification in order to add toxicity and adverse event data following the FDA’s investigation. Even worse, those patients currently enrolled in an Iclusig clinical trial, or those taking the medication outside the trial may be faced with an agonizing decision: continue the drug which could potentially make the difference between a fatal disease and a chronic, but treatable disease, or stop taking the drug due to the high risk of negative health effects.
Iclusig is generally used as a “last-chance” drug, after other similar drugs or therapies have failed to show any positive benefits. Although the FDA approved Iclusig under an accelerated program, they nonetheless required a Black Box Warning regarding the risks of blood clots or liver toxicity. While Ariad’s press release regarding the PACE trial data results stated blood clots could occur in 11.8% of patients at 24 months, that number is now believed to be much higher. While Ariad maintains the suspension is temporary and that no recall is in sight, the FDA may narrow Iclusig’s labeling to state that only patients who have had no success with two other therapies or who have the specific gene mutation Iclusig targets will be eligible. No new patients will be enrolled in the ongoing clinical trials until the suspension is lifted, and those already taking Iclusig will need to make special application to remain on the drug if it appears to be helping them.
Should You File an Iclusig Heart Attack Lawsuit?
The FDA investigation which resulted in the Iclusig suspension showed an increased frequency of blood clots and narrowing of blood clots. 24% of patients in one clinical trial, and 48% in another experienced serious, sometimes fatal or life-threatening adverse vascular events such as heart attack, blood flow and stroke. Worsening of coronary artery disease, severe narrowing of blood vessels, congestive heart failure, loss of blood flow to the extremities or the eyes, gastrointestinal perforation, pancreatitis and liver failure are all potential side effects of Iclusig. Because the suspension is so recent, and all the facts are not yet in, it is not yet known whether Iclusig heart attack lawsuits will be filed in the future. The number of patients who experienced cardiovascular events and the level of harm will factor into future Iclusig stroke and heart attack lawsuits.
The Differences between Iclusig MDL’s and Iclusig Class Action Suits
In the future, depending on a variety of issues, consumers harmed by Iclusig may choose to join an MDL Iclusig lawsuit if one is created or an Iclusig class action suit, if a class is certifed. Class action lawsuits include comparable claims from a group of people injured by the same defendant—in this case, Ariad Pharmaceuticals. The advantage of an Iclusig class action lawsuit, should a class be certified, is that a leveraged settlement may be reached without the need for individual litigation. The primary disadvantage is that should a settlement be reached, it will be divided equally between plaintiffs, regardless of the level of harm suffered. An MDL lawsuit in general has an advantage in that settlements are determined based on each individual case, therefore a person who has suffered extreme harm from a defective or dangerous drug will receive a larger settlement than a person with less serious symptoms.
Iclusig Wrongful Death Attorney
It is likely that Iclusig lawsuits will be filed in the coming months, what is not clear is how many patients were adversely affected by the drug or to what extent. Speaking with an experienced Iclusig wrongful death attorney could be beneficial for those who believe Iclusig was responsible for the death of a loved one.