The FDA has requested that the manufacturer of Iclusig, Ariad Pharmaceuticals, suspend marketing and sales of the leukemia treatment due to potentially life-threatening side effects.
A recent investigation showed an increased frequency of blood clots and narrowing of blood vessels. About 24% of patients in one clinical trial and 48% of patients in another experienced serious, sometimes fatal or life-threatening adverse vascular events—this includes problems with blood flow, heart attack, and stroke.
If you’re taking Iclusig and it’s working for you, the FDA recommends that you discuss the risks vs the benefits with your health care provider. If the benefits do outweigh the risks, you’ll need to be treated under a special access program. You can find more information on the program here.
If you’re taking Iclusig and it hasn’t been helping, the FDA recommends that you speak to your provider about immediately discontinuing treatment and finding an alterntaive.
For more information and updates, see the FDA bulletin here.