Xgeva, whose chemical name is denosumab, is approved for use in those suffering from advanced prostate cancer which has moved into the patient’s bones. The drug is approved to help prevent fractures in these patients. It is administered by injection. The drug is manufactured by Amgen, Inc.

Sales of Xgeva have skyrocketed in recent months. In fact, in the first quarter of this year alone, Xgeva sales have risen an astonishing 14 percent. Amgen’s profits from Xgeva were $153 million in that quarter alone. Amgen – and wall street analysts – believe that the drug will soon account for $1 billion a year in sales.

However, last week the Food and Drug Administration (the FDA) rejected Amgen’s request to expand the use of Xgeva to help prevent tumors from spreading into the bones of patients with advanced-stage prostate cancer. The FDA’s refusal was based on a determination that the risks to patients outweigh the benefits.

The principal concern with the use of Xgeva is the possibility of jawbone injuries. Studies have shown that use of the drug can lead to a condition which destroys the jawbone entirely.
The FDA did, however, leave open the possibility that the proposed use of Xgeva will ultimately gain approval. The agency, while denying approval today, also asked for Amgen to provide data from further trials.

Nor is Amgen giving up on expanding Xgeva’s use in other areas. Amgen is currently testing the drug in patients with other forms of cancer, including breast cancer and lung cancer.

Amgen, Inc. is the world’s single largest biotechnology company. Its growth in recent years has been primarily driven by Xgeva and Polia, a drug used to treat osteoporosis. Analysts predict that expanding use of Xgeva and Polia will help Amgen to make up for declining sales of its anemia drugs.

Sadly, the story of Xgeva is not novel to those experienced in pharmaceutical products liability. Drug companies such as Amgen are increasingly driven solely by profits, minimizing or ignoring entirely the health and well-being of the patients they supposedly exist to help. Amgen’s push to expand Xgeva’s use into as many areas as possible, despite known safety concerns, mirrors the actions of numerous other pharmaceutical companies, and will surely be repeated again.

Our experienced products liability attorneys urge the FDA to stand fast against Amgen’s push to expand Xgeva use, and the many similar efforts to unreasonably expand the use of various prescription drugs in the United States. As the manufacturers of these drugs cannot and will not protect the patients they service, the FDA itself must stand in the way of the constant push to subject more and more Americans to these dangerous treatments.

For a free consultation with an experienced Chicago products liability lawyer at Passen Law Group, call us at (312) 527-4500.

In yet another example of the inadequacy of federal regulators to protect patient health, the FDA this month issued recommendations for measures to ensure that Heparin, the popular blood-clot prevention drug, was produced safely. While our products liability attorneys applaud the issuance of such recommendations, it is important to note that the agency has finally taken this step four years after the contamination scare which rocked drug users worldwide.

Heparin, a blood thinner derived from pig intestines. The drug was previously produced by Baxter International, Inc., a major U.S. pharmaceutical supplier, but the company sold this portion of its business last year to Hikma Pharmaceuticals Plc.

In the early months of 2008, the FDA first began receiving reports of problems with Heparin, with users reporting serious reactions to the drug. Many users were hospitalized, left on dialysis, and even killed. These problems were traced to the Heparin – and led to a large products liability problem that rocked the international pharmaceutical industry.

The FDA then conducted a probe, and determined that a contaminant was present in some Heparin batches. The contaminant was then traced to certain of Heparin’s active ingredients, which were themselves manufactured in China. Subsequent investigations determined that the contamination with oversulfated chondroitin sulfate (OSCS) “appeared” to be intentional – a move by the Chinese manufacturers to use OSCS as a filler to reduce the costs of production. Hikma asserts that it now uses only materials from the U.S. and Canada in the production of Heparin.

The Heparin problems triggered massive public outcry, and eventually led to congressional hearings about drug products and components manufactured in foreign plants – and the lack of oversight and inspections at those plants.

The FDA posted the draft guidance on its website, stating that it was designed to assist the manufacturers of Heparin’s active ingredients (and the finished product) to avoid contamination. Said FDA Commissioner Margaret Hamburg, “We’re making sure we have systems in place to prevent that particular problem.” In addition to the original contamination, the FDA has also expressed concern about the substitution of cow-based heparin, which could lead to contamination with mad-cow disease.

The draft guidance calls for testing of each shipment of crude heparin, including testing to determine the species origin (to ensure that it is pork-based), and to look for the OSCS. Testing would be done before the manufacture of the drug Heparin from the crude ingredients. The draft guidance also calls for manufacturers to audit their suppliers.

While encouraging, the FDA’s draft guidance is a classic case of “too little, too late.” First, it is phenomenal that the FDA has taken four years to take action on this very serious problem. The draft will now be open for comment for 60 days, at which point the FDA will decide whether to make changes, resulting in additional delays, or issue the guidance in non-draft form.

In addition, the proposed guidance is just that – guidance. Even if adopted, it would simply be a list of recommendations for manufacturers, and would not create any legally-binding, or enforceable, rules or responsibilities.

Our top products liability attorneys are disappointed that FDA action has taken this long, and dismayed that, in the end, the FDA has chosen to issue only “guidance,” without taking any real action to protect consumers. We urge the agency to reconsider, and to make this guidance binding, requiring manufacturers to take these very basic steps to protect U.S. patients and the public.

For a free consultation with an experienced Chicago products liability lawyer at Passen Law Group, call us at (312) 527-4500.