Last Thursday, the United States Food and Drug Administration (FDA) announced that manufacturer Ariad Pharmaceuticals agreed to suspend its marketing and sales of the leukemia drug Iclusig. The announcement follows an intense investigation conducted by the FDA in which it was discovered that the drug can cause an increased frequency of blood clots and narrowed blood vessels in users. Approved in December of 2012, it has not yet been determined if the drug’s benefits outweigh its risks – an issue that the FDA is currently looking into. Accordingly, patients who are currently using the drug are advised to immediately discuss the risks and benefits of continuing treatment with their physicians.
The FDA’s evaluation of Iclusig is ongoing. In the meantime, patients and healthcare professionals alike are urged to follow the FDA’s new recommendations for use of the drug, which include:
- Current users of Iclusig should immediately discontinue treatment if they are not responding to the drug. Alternative treatment options should be discussed with a healthcare professional.
- Current users of Iclusig who are responding to the drug and whose physicians have determined that the drug’s benefits outweigh its risks need to be treated under a single-patient Investigational New Drug (IND) application. An expanded access registry program may also be applicable in this situation. The FDA plans to work with the manufacturer to create a plan that will allow for the quick transition of these patients to a program that allows for access under an IND or expanded access registry program.
- Unless no other treatment options are available, professionals in the health care field should refrain from treating new patients with Iclusig. Treatment of leukemia with Iclusig may be an option if all other treatment options and available therapies have failed.
Serious, adverse vascular issues have been experienced by 24% of patients in Phase 2 of the FDA’s investigation; approximately 48% of patients in Phase 1 of the clinical trial have been documented as experiencing adverse side effects. Health conditions that have been identified among patients who’ve suffered from the use of Iclusig include:
- Heart attacks
- Loss of blood flow to the extremities
- Tissue death
- Narrowing of blood vessels in the extremities, heart, and brain
The FDA has not yet identified a dosage level for safe amounts of the drug, nor has it remarked on the safe level of exposure duration. What the FDA has found is that the serious – sometimes fatal – effects of Iclusig among users developed as early as two weeks after beginning Iclusig therapy. The FDA has stated that it will notify healthcare professionals and patients as more information about the issue is made available.
If you or someone you love were harmed by the potentially adverse side effects of Iclusig, you can turn to The Senator Firm for representation from a California defective drug attorney at our office. Call us today at (949) 557-5800.