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.

With over 9,000 Stryker ABGII hip implant devices sold prior to the Stryker recall in July, 2012, there are thousands of patients wondering just what is wrong with the Stryker ABGII. The ABGII modular-neck hip implant submitted premarket notification to the FDA in August, 2009, and received approval notice under the controversial 510(k) FDA process in October, 2009. Marketing for the Stryker ABGII began in earnest in early 2010, yet soon thereafter adverse reports began filtering in to the FDA from recipients of the device. There were complaints of inflammation, chronic pain, hip failure and symptoms of metal toxicity from ABGII implant recipients across the United States.

Sales of Iclusig, a drug used primarily in the treatment of chronic myeloid leukemia, were recently suspended in a joint decision between the FDA and Ariad Pharmaceuticals, the manufacturer of Iclusig. Iclusig gained FDA approval less than a year ago, in December, 2012. At the time the drug was approved—under an accelerated process –clinical trials had demonstrated a higher-than-normal risk of cardiovascular events among those taking Iclusig. This risk required Ariad to include a boxed warning alerting patients and physicians to the risks of blood clots and liver toxicity in patients taking Iclusig.

The Stryker ABGII hip implant device was recalled in July, 2012, after being on the market since only 2009, when it received FDA approval. At the time of the recall, Stryker noted the risk of fretting and corrosion, leading to excess metal ion debris generation. These microscopic cobalt and chromium ions travel to the bloodstream or become lodged in the hip tissues, leading to serious health problems in some people. Stryker has been relatively quiet about why the ABGII hip implant has had so many problems, particularly since the design was believed to be a particularly novel approach which would correct many of the problems associated with all-metal hip implants.

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.