The Iclusig FDA Investigation
Iclusig, a drug manufactured by Ariad Pharmaceuticals to treat resistant chronic myeloid leukemia, gained FDA approval last December—almost three months ahead of the anticipated timeline. Iclusig gained orphan product designation as it is intended to treat a rare disease or condition. The special FDA program provides for an expedited approval for drugs which may provide safe and effective therapy for patients with diseases which have no satisfactory alternative therapy. Iclusig works by blocking specific proteins which appear to encourage the growth of cancerous cells and is generally used when other similar tyrosine kinase inhibitors have failed to work or the cells have become resistant.
Iclusig is the third drug approved by the FDA in 2012 to treat CML, and its approval was based on a single clinical trial consisting of 449 patients in varying stages of CML and Ph+ALL. In this particular trial, 52% of patients being treated achieved a major hematologic response while taking Iclusig, however a significant number also suffered a cardiovascular event: stroke, heart attack or blood clot. In fact, although Iclusig was approved, the FDA required a Black Box Warning on the label cautioning patients of the increased risk of blood clots and liver failure. Representatives from Ariad maintain that this suspension of sales is only temporary and that a recall is not in the future for Iclusig.
Iclusig FDA Warnings and the Iclusig FDA Drug Safety Communication
In the meantime, reductions in dosage for those currently taking Iclusig will be determined on a case-by-case basis. Patients who are responding well to the drug may choose to continue taking it, under a special access program, however no new patients will be enrolled in clinical trials. Further, the eligibility criteria for Iclusig clinical trials will be adjusted so that patients who have experienced any prior cardiovascular events will be excluded. Recent investigations into the efficacy and safety of Iclusig showed an alarming increase in frequency of blood clots and narrowing of blood vessels—48% in one clinical trial and 24% in another. The FDA issued a safety announcement on October 11, 2013, which informed the public that at least 20% of those taking Iclusig had developed blood clots.
Serious Iclusig Side Effects
The price of Iclusig is estimated to be between $100,000 and $115,000 per year per patient. The following side effects may occur in those taking Iclusig:
· Congestive heart failure
· Amputation due to loss of blood flow to extremities
· Heart attacks, some fatal
· Stroke
· Narrowing of the arteries which go to the brain
· Coronary artery disease which worsens
· Blood clots in the blood vessels which go to the eyes
· A diminishment of vision
· Gastrointestinal perforation
· Fluid retention
· Pancreatitis
· Liver failure
· Lesser side effects such as chronic headache, joint ache, dizziness, skin rashes and abdominal pain, anemia and compromised wound healing
These side effects—even the most serious cardiovascular side effects—appear to have no correlation to patient age or previous history of heart trouble. The FDA has recommended that physicians not start patients on Iclusig unless no other treatment options exist or other treatments have failed. Patients who have suffered serious cardiovascular events or other adverse health issues could gain support and assistance from speaking to a knowledgeable Iclusig attorney.