Why Sales of Iclusig Have Been Suspended
Safety concerns related to the drug Iclusig, manufactured by Ariad Pharmaceuticals, recently came to light, causing the FDA and the manufacturer to agree to a temporary suspension of sales. No new patients will be enrolled in clinical trials, although the patients who are doing well on the drug may continue to take Iclusig. Iclusig is one of five drugs currently used in the treatment of chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia. Some 5,000 new cases of chronic myeloid leukemia occur each year, with approximately 600 deaths annually from the disease.
Iclusig is generally considered a treatment for extremely resistant cases or those in which other drugs proved ineffective. Some patients are expected to require Iclusig for life in order to take their disease from a potential life sentence to a chronic, yet treatable, disease. Other patients could find the $115,000 annual cost of Iclusig prohibitive. Iclusig was given an accelerated approval from the FDA under a program for a potentially effective drug therapy when no alternative therapies exist. Iclusig works by blocking specific proteins which promote the development of cancerous cells in blood cancers such as chronic myeloid leukemia. The FDA has stated they will continue to work with Ariad Pharmaceuticals in order to understand the risks as well as identifying those patients for whom the benefits of Iclusig would outweigh the risks.
Risks of Iclusig
Serious arterial thrombosis (blood clots), have been seen in almost 12% of Iclusig-treated patients after only two years of treatment. Patients currently enrolled in an Iclusig clinical trial may have their dosages changed from 45mg to 30 mg unless they have achieved a “major molecular response,” in which case the dosage could drop to 15 mg. The FDA reports that after less than a year on the market, nearly a fourth of all Iclusig patients who have taken the drug for up to 1.3 years have experienced a serious adverse vascular event, while 48% of patients taking the drug for up to 2.7 years experienced some type of serious adverse vascular event. Further serious side effects seen in patients taking Iclusig have experienced narrowing of large arteries to the brain, narrowing of blood vessels in the extremities, congestive heart failure, clots in the blood vessels of the eye, decreased vision, liver failure, pancreatitis, hypertensive crisis, compromised wound healing and gastrointestinal perforation.
The Iclusig Statute of Limitations
Patients who have suffered harm from the drug Iclusig should be aware of the Iclusig statute of limitations which is a legal enactment setting the maximum time following an adverse event in which a lawsuit may be initiated. Over half of the states in the U.S. operate under the two-year statute of limitations rule, although other states extend that time limit to three, four, six and even ten years’ time. The state of Texas operates under a two-year statute of limitations, while other states may have different statutes of limitation. Victims of a defective or dangerous drug may want to speak to a knowledgeable Sullo & Sullo attorney in order to determine when their state’s statute of limitations began. It is important that the statute of limitations not be exceeded or the injured party may be prohibited from filing a recovery case. The statute of limitations is intended to protect companies or manufacturers from being exposed to lawsuits for long periods of time as well as preserving evidence.
Iclusig Claim Preservation
The attorneys of Sullo & Sullo understand Iclusig claim preservation and should we determine you have a potential case against Ariad Pharmaceuticals, we will oversee filing your claim. We offer advice and counsel regarding the best way you can move forward following the harm you have experienced from a drug you believed to be safe. We truly care about each and every client and will be with you from start to finish. Experienced Sullo & Sullo attorneys can offer compassion and skill to those injured by the drug Iclusig; we have the information and knowledge and will fight hard for our clients to receive the help they need. Getting Iclusig legal help can be as simple as picking up the phone to call a Sullo & Sullo attorney or as easy as filling out an online form while on our website.