Avandia RECALL

Avandia News

09/23/2010 - GlaxoSmithKline Plc’s Avandia, once the world’s best-selling diabetes drug, will be withdrawn from the market in Europe and sales will be limited in the U.S. because of an increased risk of heart attacks, regulators said in decisions announced almost simultaneously.More>>>

09/08/2010 - GlaxoSmithKline Plc’s Avandia diabetes treatment should be withdrawn from the market and never should have been approved, the British Medical Journal’s Editor- in-Chief Fiona Godlee wrote as European regulators prepare to review the drug’s safety.More>>>

08/23/2010 - Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug's maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company's $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. More>>>

07/23/2010 - More than nine out of 10 scientists who backed a drug at the centre of a safety scare had financial links to the pharmaceutical industry, a study has found.More>>>

07/20/2010 - One of the three panelists who recommended that the U.S. Food and Drug Administration allow GlaxoSmithKline to continue marketing Avandia with no further restrictions is a paid speaker for the drug company, reports The Wall Street Journal. More>>>

07/16/2010 - It remains unclear whether the most closely watched FDA advisory panel in years will prove to be the death knell or a life raft for rosiglitazone. More>>>

07/14/2010 - Federal advisers delivered a mixed verdict Wednesday on the diabetes drug Avandia, with a significant number of experts voting to recommend that it be pulled from the market because of safety concerns but a majority urging to keep it available, perhaps with tough new restrictions and new warnings.More>>>

07/12//2010 - A large clinical trial of Avandia, sponsored by its maker, "was inadequately designed and conducted to provide any reassurance" that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday. More>>>

07/12//2010 - The popular diabetes drug Avandia may be far more dangerous to patients than reported in a study touted by the drug's manufacturer, according to a strongly worded report posted Friday by the Food and Drug Administration. More>>>

07/09/2010 - The drug maker GlaxoSmithKline misinterpreted crucial details of a study finding that Avandia, its blockbuster diabetes drug, is safe, a medical reviewer for the Food and Drug Administration said Friday. More>>>

07/06/2010 - The count down to the re-review of GlaxoSmithKline plc's controversial diabetes pill Avandia has begun! More>>>

06/01//2010 - GlaxoSmithKline Plc has settled thousands more lawsuits brought by patients alleging its Avandia diabetes drug caused heart attacks, in a move that may defuse potentially massive claims over the medicine. More>>>

05/20//2010 - GlaxoSmithKline PLC is facing difficulties recruiting patients in the U.S. for a large clinical trial of its diabetes drug Avandia, in the wake of several studies linking the medicine to an increased risk of heart attack. More>>>

05/11//2010 - An major trial of Avandia puts patients at risk and should be stopped, a U.S. advocacy group said on Tuesday in calling on regulators to halt the global study of the controversial GlaxoSmithKline Plc diabetes drug.More>>>

05/10//2010 - GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users, people familiar with the accords say. More>>>

04/21/2010 - GSK’s Avandia just won’t stay out of the news. Now comes a report from The Wall Street Journal that the FDA is considering dealing the beleaguered diabetes drug another blow by stopping one of its safety trials. The TIDE trial, which received approval in 2007, pits Avandia (rosiglitazone) against Takeda’s Actos (pioglitazone), a drug that as yet hasn’t suffered from the same safety pitfalls. More>>>

04/20/2010 - U.S. regulators are reviewing the safety of GlaxoSmithKline P.L.C.'s Avandia diabetes drug as they weigh whether to suspend a trial testing the medicine, Bloomberg News reported. The Food and Drug Administration is reassessing a study comparing Avandia with a rival medicine from Takeda Pharmaceutical Co., and whether it is ethical to pursue the research after studies tied the Glaxo drug to an increased heart attack risk, according to a letter from FDA Commissioner Margaret Hamburg, dated March 30, the news servicesaid. More>>>

04/19/2010 - The Food and Drug Administration is weighing whether to halt a safety study involving thousands of patients taking GlaxoSmithKline PLC's Avandia diabetes drug, a decision that could also determine whether the drug stays on the U.S. market. Studies during the past three years have tied the medicine to an increased risk of heart attacks. More>>>

04/15/2010 - A new analysis of reviews and articles about the controversial diabetes drug Avandia has found that experts who were paid by its manufacturer have been significantly more likely than others to draw positive conclusions about the drug’s safety and efficacy. More>>>

03/31/2010 - Diabetes is particularly detrimental to the heart, and heart problems are the eventual cause of death for most patients with diabetes. Given this, it is extremely worrisome that Avandia, a drug marketed to treat diabetes, has been found to harm the heart. More>>>

03/25/2010 -Avandia is a diabetes drug that is usually given to senior citizens. It helps control blood sugar levels by making the cells of the body more sensitive to the action of insulin. Avandia is for people with Type 2 (non-insulin dependent) diabetes. It is sometimes used in combination with other medications, but it is not for treating Type 1 diabetes. However, there are recent studies that Avandia is harmful for the heart, and increases the chances of getting a heart attack. More>>>

03/22/2010 - Saudi Arabia has suspended GlaxoSmithKline's (GSK.L) diabetes drug Avandia for six months, arguing that potential heart risks outweigh its benefits. The Saudi Food and Drug Authority (SFDA) was the first healthcare regulator to take such action. Its decision means detailing and advertising of Avandia is banned and patients on Avandia will be referred to their doctor for consultation. More>>>

03/15/2010 - The UBS (Union Bank of Switzerland) reported publicly last week that pharmaceutical giant GlaxoSmithKline PLC could end up liable for more than $6 billion in settlements and compensation for serious health complications caused by the company’s popular diabetes treatment medication Avandia. The type-2 diabetes prescription drug has been linked with severe heart problems, including heart attacks.More>>>

03/08/2010 - With its alarming rise and high number of diabetes cases, India is called the diabetes capital of the world — the sugar disease is emerging as an enormous health problem in the country. Various studies have shown that the high incidence of diabetes in India is mainly because of sedentary lifestyle, lack of physical activity, obesity, stress and consumption of diets rich in fat, sugar and calories. Among the various drugs used to treat the disease, one of it is Rosiglitazone, which is used to treat type II diabetes. However, lately there has been some dispute over the effectiveness of the medicine and its side effects. More>>>

More HERE