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 Avandia Information - January 9, 2009
| The U.S. Food and Drug Administration (FDA) said on Tuesday that GlaxoSmithKline Plc. and Takeda Pharmaceutical Company Ltd. have agreed to include "black- box" warnings for the controversial diabetes drugs Avandia and Actos. The warnings, the strictest ever a prescription drugs can bear, means that the medicines can cause or worsen heart failure. The patients are advised to closely monitor the medicine for symptoms | | Panelists from the U.S. Food and Drug Administration (FDA) on Monday approved the widely used diabetes drug Avandia to remain on the market by a 22-1 vote. FDA advisers ruled that current evidence linking the Type-2 diabetes drug to an increased risk of heart attack is not strong enough to order Avandia's removal from the market. The panel also recommended that Avandia, also known as rosiglitazone, should be studied further and should carry a "black-box" warning. Some experts also suggested the label caution against using the drug together with insulin, because current studies suggest that doing so may elevate heart risks. Nonetheless, the joint use of Avandia and insulin is currently FDA-approved | | The U.S. Food and Drug Administration (FDA) plans to seek comments from drug safety experts on Monday if GlaxoSmithKline's diabetes drug Avandia should carry label warnings of heart attack risk. On July 30th, the FDA's Endocrinologic and Metabolic Drugs advisory committee and the Drug Safety and Risk Management advisory panel will discuss cardiovascular risks associated Avandia's class of drugs, thiazolidinediones | | A new U.S. study says that an older drug called metformin, sold as Glucophage is still the best for treatment of the most common form of diabetes and is much better than a new generation of medications in many cases. The new report is seen to further hurt sales of Avandia, a pill recently tied to heart problems. However, experts also add that doctors should not abandon prescribing the new drugs for type 2 diabetes, because they may be appropriate in some other patients | | The U.S. Food and Drug Administration has reportedly issued a warning concerning the drug Avandia (rosiglitazone) - a drug used to treat type 2 diabetes. The FDA says safety data from controlled clinical trials has shown a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. The study shows that Avandia increases heart attack risk by 43 percent and increases risk of death from heart disease by 64 percent | |
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