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Propoxyphene withdrawn from U.S. market

Because the risk of cardiac toxicity outweighs the pain relief benefit, the FDA has asked manufacturers of the prescription opioid propoxyphene to voluntarily remove the drug from the market. A new study has shown that even when taken at recommended doses, propoxyphene may cause prolonged PR intervals, widened QRS complexes, and prolonged QT intervals, increasing the risk of serious dysrhythmias and sudden death. Data also indicate that the risk of adverse reactions for patients who've taken the drug for years can change based on small changes to the patient's health status, such as dehydration, a change in medications, or decreased renal function.

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The FDA urges healthcare professionals to stop prescribing and dispensing products containing propoxyphene. Tell patients currently taking the drug to contact their healthcare providers to discuss risks and find an alternative treatment.


Source: U.S. Food and Drug Administration. Xanodyne agrees to withdraw propoxyphene from the U.S. market.


Low-dose aspirin to reduce colon cancer risk?

Researchers reviewing the 20-year results of four clinical trials conducted to study the use of aspirin in preventing strokes have found that participants taking low doses of aspirin daily decreased their risk of colon cancer by 24%. They also noted that deaths from colon cancer dropped 35% in those taking daily aspirin.


Previous studies have shown that high-dose aspirin (500 mg or more daily) reduces the long-term incidence of colorectal cancer, but the adverse reactions related to such high doses outweigh the benefit. This new study, however, showed that at least 75 mg of aspirin taken daily for several years reduced the long-term incidence and mortality of colon cancer (but not rectal cancer). The greatest benefit was seen for cancers of the proximal colon.


The researchers suggest that individuals at high risk for colon cancer, such as those with a family history of the disease or a previous polyp, should consider taking low daily doses of aspirin.


Source: Rothwell PM, Wilson M, Elwin CE, et al. Long-term effect of aspirin on colorectal cancer incidence and mortality: 20-year follow-up of five randomised trials. Lancet. 2010; 376(9754):1741-1750.


New indication approved for antidepressant

The selective serotonin-norepinephrine reuptake inhibitor duloxetine has been approved by the FDA to treat discomfort from osteoarthritis and chronic low back pain. The drug was first approved in 2004 to treat major depressive disorder. Since then, it has also been approved to treat generalized anxiety disorder, diabetic peripheral neuropathy, chronic musculoskeletal pain, and fibromyalgia.


Clinical trials involving more than 600 patients with osteoarthritis and chronic low back pain were conducted in four double-blind, placebo-controlled, randomized trials. At the end of the trials, the patients taking duloxetine had significantly greater pain reduction compared with those taking a placebo.


Source: Food and Drug Administration. FDA clears Cymbalta to treat chronic musculoskeletal pain.


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