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

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 to cut jobs says report

"British drug maker GlaxoSmithKline will cut thousands of jobs when it announces full-year results this week, media reports said on Sunday. The Sunday Telegraph said up to 6,000 posts would be eliminated around the world. The Observer said as many as 10,000 jobs could go - 10 per cent of the company's global work force. GlaxoSmithKline PLC spokesman Phil Thomson would not comment on the reports, but said the company had "an ongoing restructuring program". Major pharmaceutical manufacturers are facing increasing competition from generic rivals to their best-selling drugs. Like its rivals, Glaxo has already been cutting jobs to help make savings. The company aims to shave STG700 million ($A1.54 billion) off its annual cost base by 2010. Last week, rival AstraZeneca confirmed plans to slash another 6,000 jobs, bringing its total cut to 15,000. US drug maker Pfizer Inc also has cut almost 15,000 jobs in the past two years" - MSN Australia

GSK starting huge study on new type of heart drug

Drugmaker "GlaxoSmithKline PLC is making a big investment in a new type of drug for the gigantic heart disease market, announcing Thursday it is starting a 15,000-patient, late-stage study of its experimental compound darapladib. The drug is meant to keep plaque deposits in heart arteries stable, so they don't rupture - the top cause of heart attacks and strokes. If approved, this would be the first drug in a new class that inhibits an enzyme called Lp-PLA2, Patrick Vallance, head of drug discovery at the British pharmaceutical company, told The Associated Press"

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