FDA Updates Info Guide on Avandia Side Effects

FDA Updates Info Guide on Avandia Side Effects (February 5, 2011) U.S. Food and Drug Administration (FDA) announced Thursday that updated information of Avandia side effects has been added to physician labeling and patient Medication Guide. The FDA, a federal agency of the U.s, is accountable for protecting and promoting public health through the regulation and supervision of food safety, medicines, and several other products. They first announced the new restrictions for prescribing and use of Avandia on September 23, 2010, after several studies showed the drug increased threat of heart failure and other cardiovascular complications. Avandia, genetically known as rosiglitazone, is an oral anti-diabetic agent marketed by GlaxoSmithKline, the world’s third largest pharmaceutical company based in London, UK. This anti-diabetic drug, which acts primarily by increasing insulin sensitivity, improves glycemic control while reducing circulating insulin levels. It was initially approved by the FDA on May 25, 1999. In 2001, FDA questioned GSK for downplaying the potential possibilities of heart failure associated with its manufactured anti-diabetic drug. The risks were confirmed by the pharmaceutical company in 2005, saying that there may be a number of health risks attributed to the drug. In 2007, a meta-analysis of 42 clinical studies showed that the drug is associated with an increased risk of myocardial ischemic attack, including angina and myocardial infarction. In May 2007, the FDA ordered a full withdrawal of Avandia from the market, saying the drug increases the risk of cardiovascular system attacks by 43 percent and the risk of cardiovascular death by 60 percent. As of last year, GSK reached settlement agreements amounting to $520 million to settle more than 10,000 suits against it. Early this year, the pharmaceutical company agreed to pay $3.5 billion to settle an Avandia lawsuit filed by a patient who died of a heart attack after taking the anti-diabetic drug. A company representative said that the settlement means other Avandia lawsuits have been resolved.

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