NEJM -- A Difficult Balance -- Pain Management, Drug Safety, and the FDA

FDA’s Woodcock Discusses Pain Management and Drug Safety in Nov. 26, 2009 Issue of The New England Journal of Medicine
An article by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, titled “A Difficult Balance – Pain Management, Drug Safety, and the FDA,” appears in the Nov. 26, 2009 issue of The New England Journal of Medicine.

In the article, Woodcock discusses FDA efforts to strike a balance between access to pain medication for those who need it and managing the risks posed by various analgesics. As examples, she cites recent FDA actions on acetaminophen, the low-potency opioid propoxyphene, and high-potency opioids such as Oxycontin.

These actions are part of the FDA's ongoing Safe Use Initiative, aimed at reducing the likelihood of preventable harm from medication use. Millions of people are harmed every year from inappropriate medication use. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient's condition. Other preventable sources of harm include unintentional misuse of medications, medication abuse, and attempts at self harm.

For more information see below

FDA Web Page on Safe Use Initiative
http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188961.pdf

The New England Journal of Medicine
http://content.nejm.org/


A Difficult Balance — Pain Management, Drug Safety, and the FDA
Janet Woodcock, M.D.

Pain is a common medical problem, and relief of pain is an important therapeutic goal. Although nonpharmacologic approaches to treating pain (e.g., behavioral techniques) show promise for certain conditions, pain is most commonly treated with analgesics. Over the past decade, there have been growing concerns about the harm — abuse and addiction, as well as serious injury and death — caused by the use of prescription and over-the-counter analgesics. These concerns have emerged in parallel with the evolving understanding of the importance of pain management in medical care. We at the Food and Drug Administration (FDA) have been engaging physicians, pharmacy groups, patients, and other stakeholders in an ongoing effort to strike the right balance between two important goals: on the one hand, providing access to pain medications for those who need them, and on the other hand, managing the variety of risks posed by analgesic drugs. Recent FDA advisory committee meetings and actions reflect this effort.

Acetaminophen is one of the most commonly used analgesics. In 2008, approximately 25 billion doses were sold in the United States.1 Acetaminophen is marketed as a single-ingredient drug but can also be found in a multitude of over-the-counter combination products, such as cough and cold medicines, as well as in prescription opioid–acetaminophen combination products (e.g., Vicodin [Abbott], Percocet [Endo Pharmaceuticals], and Darvocet [AAIPharma]). Although acetaminophen, when used as labeled, is generally safe, the ubiquity of the drug and its relatively narrow therapeutic index create the potential for serious harm from both inadvertent and intentional overdoses (for related emergency department visits, see bar graph). Approximately 30,000 hospitalizations are associated with acetaminophen overdose in the United States annually — approximately half of them resulting from unintentional overdose.2 Acetaminophen is also a leading cause of acute liver failure in the United States.

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NEJM -- A Difficult Balance -- Pain Management, Drug Safety, and the FDA