Iclusig is among only a handful of drugs used in the treatment of leukemia and is part of the class of Kinase inhibitors. Kinase inhibitors are also used to treat cancers such as melanoma, lung cancer, renal cancer and breast cancer and are used in certain instances to treat rheumatoid arthritis or prevent organ transplant rejection. Kinase inhibitors work by stopping the growth of cancer cells and preventing the spread of those cells. More specifically, Iclusig is a tyrosine-kinase inhibitor, meaning it disrupts enzymes within cancer cells. Iclusig is prescribed for those patients whose particular cancers are hard-to-treat or impervious to other forms of treatment including other tyrosine-kinase inhibitor drugs.
Iclusig Drug Sales
Even at the time Iclusig was approved and marketing began, the drug was considered problematic for at least two reasons. In the initial clinical trials, Iclusig was found to cause blood clots, and liver toxicity. These findings led the FDA to require serious warnings on the labeling of Iclusig. Preliminary clinical trials showed that 8% of those taking Iclusig developed blood clots in the arteries while 3% of those patients developed blood clots in the veins. These numbers, unfortunately, escalated between the time of approval and less than a year into marketing.
Iclusig Adverse Events Increase
A recent investigation showed an increased frequency of blood clots and narrowing of blood vessels in those taking Iclusig. One-quarter of patients in a clinical trial at approximately 1.3 years and nearly half of patients in another clinical trial at approximately two years have experienced serious, potentially life-threatening or fatal adverse vascular events. The second reason the drug is controversial relates to the price tag: a year of Iclusig can cost between $100,000 and $115,000. Now, only ten months following approval of Iclusig, the FDA is now requesting that the manufacturer—Ariad Pharmaceuticals—suspend marketing and sales of Iclusig due to potentially life-threatening side effects.
Iclusig Drug Sales Suspended
Representatives of Ariad stress that sales of Iclusig are only being temporarily suspended. Iclusig has not been recalled, and those patients for whom the benefits of Iclusig outweigh the risks will still be allowed to be treated under a special access program. No new enrollees in Iclusig clinical trials will be allowed, and those participating in current Iclusig trials may have their dosage decreased from the “standard” dosage of 45 mg. down to 30 or 15 mg. Future Iclusig clinical trials—should they occur—will exclude those subjects who have a prior history of cardiovascular issues. The accelerated approval process used for Iclusig required Ariad to continue to conduct clinical trials and collect post-market data following that approval.
Risks of Iclusig
The Iclusig clinical trials revealed the following potential risks associated with Iclusig: Heart attacks, (some resulting in death), stroke, narrowing of brain arteries, degeneration of coronary artery disease, narrowing of blood vessels in arms and legs, congestive heart failure, decreased vision and potential clots in the eyes. If you have suffered harm from the drug, Iclusig, it could be beneficial to speak to an attorney about your potential case.