The American journal of gastroenterology
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Am. J. Gastroenterol. · Oct 2014
The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.
Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. ⋯ Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.
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Am. J. Gastroenterol. · Sep 2014
ReviewThe Use of Opioid Analgesics for Chronic Pain: Minimizing the Risk for Harm.
Chronic noncancer pain is common and consequential, affecting ∼100 million people in the United States alone and costing, when direct and indirect costs are combined, in excess of $635 billion. For certain individuals, opioids may be an effective option for the management of chronic pain; however, a series of critical decisions must be made before prescribing opioids to ensure that their potential benefits and possible risks are appropriately and realistically addressed. A thorough history, physical examination, and appropriate testing, including an assessment of risk for substance abuse, misuse, or addiction, should be conducted in patients who are being considered for opioid therapy. ⋯ Both positive and negative changes over time may necessitate a change in medication. Opioids can be prescribed safely and effectively, and when used with appropriate attention to individual patient characteristics may have a positive impact on pain and function. When contemplating initiation of opioid analgesics, clinicians would do well to make it clear to their patient that they will be prescribed on a trial basis with a clear exit strategy for discontinuing such treatment if there is no clear benefit including lack of analgesia, insurmountable adverse effects, and/or frank misuse or abuse of the prescribed drug.
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Opioid drugs have powerful antidiarrheal effects and many patients taking these drugs for chronic pain relief experience chronic constipation that can progress to opioid-induced bowel dysfunction. Three classes of opioid receptors are expressed by enteric neurons: μ-, δ-, and κ-opioid receptors (MOR, DOR, and KOR). MOR and DOR couple to inhibition of adenylate cylase and nerve terminal Ca(2+) channels and activation of K(+) channels. ⋯ Tolerance develops to the analgesic effects of opioid receptor agonists but not to the constipating actions. This may be due to differential β-arrestin-2-dependent opioid receptor desensitization and internalization in enteric nerves in the colon compared with the small intestine and in neuronal pain pathways. Further studies of differential opioid receptor desensitization and tolerance in subsets of enteric neurons may identify new drugs or other treatment strategies of opioid-induced bowel dysfunction.
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Am. J. Gastroenterol. · Sep 2014
Review Meta AnalysisThe effect of fiber supplementation on irritable bowel syndrome: a systematic review and meta-analysis.
Fiber has been used for many years to treat irritable bowel syndrome (IBS). This approach had fallen out of favor until a recent resurgence, which was based on new randomized controlled trial (RCT) data that suggested it might be effective. We have previously conducted a systematic review of fiber in IBS, but new RCT data for fiber therapy necessitate a new analysis; thus, we have conducted a systematic review of this intervention. ⋯ Soluble fiber is effective in treating IBS. Bran did not appear to be of benefit, although we did not uncover any evidence of harm from this intervention, as others have speculated from uncontrolled data.
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Am. J. Gastroenterol. · Sep 2014
Randomized Controlled TrialGranulocyte colony-stimulating factor in severe alcoholic hepatitis: a randomized pilot study.
Severe alcoholic hepatitis has high short-term mortality. The aim of this study was to test the hypothesis that treatment of patients with alcoholic hepatitis with granulocyte colony-stimulating factor (G-CSF) might mobilize bone marrow-derived stem cells and promote hepatic regeneration and thus improve survival. ⋯ G-CSF is safe and effective in the mobilization of hematopoietic stem cells and improves liver function as well as survival in patients with severe alcoholic hepatitis.