Prasugrel unanimously recommended for approval
February 4th 2009On February 3, the FDA Cardiovascular and Renal Drugs Advisory Committee unanimously recommended that prasugrel (Daiichi Sankyo/Lilly) should be approved for the treatment of patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).
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Preventable medication errors: Look-alike/sound-alike mix-ups
February 1st 2009Confusing drug names, or "look-alike/sound-alike names" (LASAs), are among the most common reasons for medication errors worldwide; these errors can lead to both morbidity and mortality. Both technological innovations and better communication can help healthcare professionals track and prevent these medication mix-ups.
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Healthcare reform requires a hard look at drug costs and savings
February 1st 2009Among members of the new administration, congressional leaders, payors, and providers, many are eager to transform the nation's healthcare system to curb unnecessary spending and make coverage more fair and efficient. A chief problem is that the US healthcare bill keeps increasing faster than the rest of the economy, with little to show in the way of quality improvement.
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Dronedarone: An antiarrhythmic agent for the management of atrial fibrillation and atrial flutter
February 1st 2009Dronedarone, an investigational antiarrhythmic agent being studied for the management of AF and atrial flutter, has a pharmacologic mechanism of action that is similar to that of amiodarone, but dronedarone lacks an iodine moiety, which may result in less thyroid and pulmonary toxicity. Dronedarone is currently pending FDA approval; the agent was granted priority review in August 2008.
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FDA seeks more resources and new leadership
January 20th 2009For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change.
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FDA guidance on reprint practices: Dissemination of off-label information OK
January 20th 2009In newly released guidance for industry regarding good reprint practices for the distribution of journal articles and reference publications on off-label uses of approved drugs, FDA states that distribution of such materials is acceptable if the publications meet certain criteria for objectivity.
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FDA: Ezetimibe/simvastatin (Vytorin) effective in lowering LDL
January 20th 2009After completing a review of the final clinical study report from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial, FDA stated that treatment with ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) did not result in significant changes in carotid artery thickness compared with simvastatin (Zocor, Merck), but the combination of ezetimibe and simvastatin did lead to significantly greater decreases in low-density lipoprotein (LDL) cholesterol compared with simvastatin alone.
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Antidepressants associated with improvements in fibromyalgia symptoms
January 20th 2009A meta-analysis published in the Journal of the American Medical Association demonstrated an association between antidepressants and improvements in pain, depression, fatigue, sleep, and health-related quality of life (HRQOL) in patients with fibromyalgia syndrome (FMS).
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