WASHINGTON—The recent nationwide shortages of critical drugs, including oncology agents, are largely the FDA's fault, according to a congressional committee report.

Since Margaret Hamburg, MD, became FDA commissioner in 2010, "the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs," reads the report issued by the House Committee on Oversight and Government Reform.

The committee said that "although the shortages have been attributed to a myriad of factors from a lack of raw materials to increased demand, [an investigation found that] the crisis was largely sparked by actions of the Food and Drug Administration."

When the FDA responds to a manufacturing problem involving producers of generic injectable drugs, the result is that "companies producing generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors also going off-line. These simultaneous shutdowns diminish the ability of competitors to alleviate the shortages with increased production," the report noted.

The FDA's regulatory interference in the production process has "effectively" forced the shutdown of 30 percent of the total manufacturing capacity of four of the largest manufacturers of injectable drugs: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals, according to the committee, which is chaired by Rep. Darrell Issa (R-Calif.).

Of the 219 drugs listed on the American Society of Health System Pharmacists shortage list as of February 21, at least 128 (58%) were produced by at least one facility undergoing FDA remediation, according to the report. A committee review of those manufacturer shutdowns over the last two years "did not find any instances where the shutdown was associated with reports of drugs harming customers."

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PARSIPPANY, N.J.— Orthopedic surgery patients with Stage 3B chronic kidney disease (CKD) are at high risk for blood clots despite standard treatment with the anticoagulant enoxaparin, according to a recently published study.

Blood clots and post-operative bleeding were reduced with use of desirudin, a new type of anticoagulant.

Results of the study, entitled “Impact Of Stage 3B Chronic Kidney Disease On Thrombosis And Bleeding Outcomes After Orthopedic Surgery In Patients Treated With Desirudin Or Enoxaparin: Insights From A Randomized Trial,” were published online ahead of print on June 4, 2012.

Desirudin, a direct thrombin inhibitor (DTI), works on a different part of the clotting system than enoxaparin. Desirudin is approved in the U.S. and Europe for the prevention of blood clots in patients undergoing orthopedic surgery. It is sold under the trade name Iprivask in the U.S. and Revasc in Europe. Desirudin, like enoxaparin, is administered by injection under the skin.

"The analysis indicates that patients with advanced kidney disease need to be approached differently when we consider issues of anticoagulation,” said Andrew Shorr, MD, Department of Pulmonary and Critical Care Medicine, Washington Hospital Center, Washington, DC, the study’s principal investigator. “The differential effects we observed between desirudin and enoxaparin demonstrate that a one-size-fits all strategy does not necessarily represent a careful balancing of risks and benefits.”

Major orthopedic surgery and advanced age are important risk factors for blood clots, which can be life-threatening. CKD is common in elderly patients undergoing orthopedic surgery and these patients have a four-fold increase in risk for blood clots as well as an increased risk for bleeding due to reduced elimination of anticoagulants. However, few studies have investigated anticoagulant performance in these high risk patients.

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