More bad news for Avandia & its link with cardiac events

"The diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) has already been suspended in Europe and is available in the U.S. and Canada on a restricted basis. A new study supports such actions as it has found the drug to be associated with significantly higher odds of congestive heart failure, heart attack and death compared with pioglitazone (Actos, Takeda Pharmaceuticals). The meta-analysis, published March 17 in the British Medical Journal, analyzed the results of 16 studies involving 810,000 patients (429,000 on rosiglitazone and 381,000 on pioglitazone). Most patients were more than 60 years old. Yoon Kong Loke, MD, senior lecturer in clinical pharmacology at the University of East Anglia in Norwich, England, and colleagues noted that both drugs, which help to control blood sugar levels in patients with type 2 diabetes, are known to increase the risk of heart failure. However, they said, "It is unclear whether there are clinically important differences in their cardiac safety. Compared with pioglitazone, rosiglitazone was associated with a modest but statistically significant increased risk of heart attack (16 percent), congestive heart failure (23 percent) and mortality (14 percent)

GlaxoSmithKline: US$3.4bn charge over Avandia and legal case

"GlaxoSmithKline has set aside £2.2bn (US$3.4bn) in the fourth quarter of 2010 to cover legal costs. The charges relate to its diabetes drug Avandia, and a federal investigation into the company's sales and promotional practices for nine other products in the United States. Avandia was banned in Europe last year while the US restricted its use because of a suspected link to heart disease. The charge is in addition to a £1.57bn charge Glaxo announced in July. That was to cover various legal settlements, including claims over Avandia, as well as antidepressant Paxil and an investigation into standards at a factory in Puerto Rico" - BBC

European Medicines Agency decides to suspend Avandia

"The European Medicines Agency has announced a recommendation to suspend Avandia (Rosiglitazone) from the European market following a review into the safety of the drug. Diabetes UK is advising anyone currently taking Avandia to consult their healthcare team without delay to discuss switching onto an alternative treatment that is best suited to their needs" - Diabetes UK

Canadian expert calls on U.S. FDA to stop 'unethical' diabetes drug trial

A leading Canadian researcher and the U.S. group Public Citizen are calling on the U.S. Food and Drug Administration to pull the plug on a major international drug trial, calling it unethical. They say the TIDE trial, which is investigating the cardiovascular risks of the diabetes drug Avandia, should be stopped because there's enough evidence to show the drug is more dangerous than a similar drug, Actos and both drugs are more dangerous than older diabetes drugs. "It really does not make sense that this trial should continue," said Dr. David Juurlink, a researcher at Sunnybrook Health Sciences Centre in Toronto who conducted an earlier large study comparing the drugs. That study, published last summer, found people taking Actos or pioglitazone for Type 2 diabetes are 23 per cent less likely to be hospitalized for heart failure and 14 per cent less likely to die than people taking Avandia or rosiglitazone - Canadian Press

Senate report: Avandia maker knew of cardiac risks (USA)

"A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007. The agency ordered a warning to be included on Avandia's label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive. Soon afterwards Sen. Grassley, one of the FDA's toughest critics in Congress, disclosed that the agency's internal safety experts came within one vote of recommending a withdrawal of Avandia" - Washington Post

GlaxoSmithKline diabetes drug faces more criticism

"Two prominent consumer groups have warned that diabetes patients should not take GlaxoSmithKline's drug Avandia because of dangerous side effects and the availability of equally effective treatments. Public Citizen, a consumer advocacy group, on Thursday called for the U.S. Food and Drug Administration to take Avandia off the market, citing several life-threatening risks, including heart and liver damage. That followed updated treatment guidelines issued last week by the American Diabetes Association, a leading patient-advocacy group, which recommended against using Avandia. The group said it was unclear whether Avandia increased heart-attack risks, but it argued that other treatments were available. The association's Web site says it receives funding from pharmaceutical companies, though not currently from GlaxoSmithKline. Another group, the American Association of Clinical Endocrinologists, whose members treat diabetic patients, continues to support using Avandia" - Philly.com