The Iclusig Suspension
Recently, Ariad Pharmaceuticals and the FDA have jointly decided to suspend sales of Iclusig, a drug used in the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. Iclusig gained FDA approval only last December under an accelerated process which required Ariad to conduct additional drug trials following approval. At the time of Iclusig’s approval, both Ariad and the FDA were well aware of the potential for blood clots and liver toxicity among those taking the drug. Because of those risks, the drug required a black box warning from the beginning. Unfortunately, it appears those risks are considerably higher than originally believed, and that as many as 20% of all patients taking Iclusig experienced dangerous blood clots. 24% of patients in one clinical trial suffered some sort of serious cardiovascular event while 48% in another trial suffered a heart attack, stroke or blood clot.
Neither a prior history of cardiovascular problems nor age appeared to be a factor in the incidence of these cardiovascular events. Ariad stresses that the suspension is temporary and that labeling is the primary issue to be resolved. While no new patients will be enrolled in ongoing Iclusig clinical trials, those already participating in an Iclusig clinical trial or patients taking the drug through prescription may be able to continue taking the drug should it be determined that the benefit outweighs the risks. For many patients, Iclusig is a last resort as far as turning their disease from a potential death sentence to a chronic, yet manageable disease. Generally, Iclusig is used after other similar drugs have proven ineffective, or when cancer cells become resistant to those other drugs.
How the Iclusig Statute of Limitations Could Affect You
The statute of limitations varies from state to state, however the majority of states operate under a two-year statute. A knowledgeable Iclusig attorney could help determine when that statute begins to run for each individual, however it is imperative that the statute not be exceeded. Patients who have suffered harm from a dangerous or defective drug will not want to find themselves unable to pursue legal action against the manufacturer due to exceeding the statute of limitations. Some speculate that the FDA may simply narrow Iclusig’s labeling to state that only patients who have seen no improvement while on two other similar drugs or those who have the specific mutation Iclusig addresses will be eligible to take the drug. Many questions must be answered before an Iclusig statute of limitation will be determined.
Do You Need Iclusig Legal Help?
It is important that Iclusig claim preservation be implemented for those who have been harmed by the drug. Experienced Iclusig lawyers understand the facts of the case and the necessity of preserving each individual claim. It is currently unknown whether Iclusig will eventually be recalled, or whether sales will resume, and if so, when.