Anemia Drug Recalled After Patient Deaths

Drug recall lawyers at Pintas & Mullins Law Firm report that partner pharmaceutical companies Affymax and Takeda recently decided to recall all lots of Omontys injections, the brand-name for peginesatide, due to reports of serious allergic reactions, which can be life-threatening and even fatal.

The injections are intended for anemic patients undergoing dialysis, and about 25,000 Americans have already received at least the initial injection. The companies sent a letter to health care professionals on February 24, 2013 stating that no new or current patients should receive any Omontys injections. The drug carries the risk of anaphylaxis, which is a serious hypersensitivity reaction. Anaphylaxis is a life-threatening allergic reaction, and symptoms develop very quickly, within seconds or minutes.

Signs and symptoms of anaphylaxis are extensive, but include abdominal pain, high-pitched breathing sounds, chest discomfort or tightness, and hives, swelling of the face, and slurred speech. Reactions have been reported to occur within 30 minutes after an initial Omontys injection. Fortunately, no reports of anaphylaxis have occurred during subsequent dosing or in patients who have completed their dialysis.

To date, there have been nearly 20 reports of anaphylaxis from dialysis centers throughout the country, three of which resulted in death. Affymax and Takeda, along with the FDA, are currently investigating these incidents and the products and facilities related to the recall. Takeda is located in Osaka, Japan, is the country’s largest pharmaceutical company and one of the world’s leading research-based drug companies. Affymax is based in Palo Alto, California and focuses on patients with kidney disease and other serious illnesses. Affymax’s stock plummeted by as much as 87% after the recall was announced.

Omontys is a type of erythropoiesis-stimulating agents (ESA) that targets hemoglobin levels, which are deficient in those with anemia. In general, ESAs carry an increased risk of stroke, serious adverse cardiovascular reactions, and death.

In clinical trials of patients with cancer taking ESAs, there was a higher increased risk of death, serious cardiovascular reactions, and tumor progression or recurrence. Use of ESAs also increased the risk of death in patients undergoing coronary artery bypass graft surgery and risk of deep vein thrombosis in those undergoing orthopedic procedures.

This is not the first time an anemia drug for kidney patients has been exposed as excessively dangerous and deadly. Just a few years ago, Epogen, Procrit and Aranesp were among the best-selling drugs in the nation, giving manufacturers Amgen and Johnson & Johnson annual sales of more than $8 billion. Epogen cost US taxpayers about $3 billion a year, as it was the most expensive drug under Medicare.

As more and more research was done on the drugs, however, it was slowly revealed that, like too many other drugs and devices on the market, the benefits were wildly overstated and the life-threatening side effects were swept under the rug. In an 84-page report, Medicare researchers found that kidney patients showed no solid evidence of improved survival or any clinical benefit besides elevating red blood cell counts. As it turned out, Amgen launched a very expensive research and lobbying campaign prior to the drugs’ release, which significantly contributed to the FDA approvals and widespread prescribing of the drug.

Both Johnson & Johnson and Amgen reportedly conducted trials that blatantly overlooked the fundamental dangers of the drugs, which included increased risk of cancer, stroke and death. The companies offered doctors and hospitals incentives to increase doses, and by 2007, about 80% of Medicare dialysis patients were being administered unsafe doses of the drugs. One report states that a physician could make anywhere between 100,000 and 300,000 dollars a year from these incentives alone.

Omontys lawyers at Pintas & Mullins Law Firm are currently evaluating cases involving serious adverse reactions from anemia drugs. These drugs have recently come under scrutiny for their understated risks and overstated benefits, and the manufacturers must be held responsible for this deception.