A new study has given further evidence that rosiglitazone can contribute to risk of heart problems and heart failure.
A new study published by The BMJ today adds to evidence that rosiglitazone - a drug used to treat type 2 diabetes - is associated with an increased risk of heart problems, especially heart failure.
For the past 100 years, diabetes has been regarded primarily as a disorder of blood glucose. And for much of the past 40 years, physicians believed that antidiabetic drugs should be prioritized by their ability to lower blood glucose towards normal levels.
At one time, Avandia (generic name: rosiglitazone) was a major diabetes drug for GSK with sales exceeding $3 billion annually. Like all drugs to treat diabetes, Avandia had received regulatory approval based on its ability to lower blood sugar which, if left untreated, can result in diabetic complication such as kidney disease, blindness, amputations and heart attacks. However, after being on the market for a number of years, a retrospective analysis conducted by Dr. Steven Nissen and Ms. Kathy Wolski at the Cleveland Clinic found that, rather than reduce heart attacks and strokes, Avandia use in diabetics resulted in an INCREASE in heart attacks and deaths in patients. Inexplicably, Avandia wasn’t providing the long-term benefit expected despite lowering blood sugar.
Today and tomorrow, the FDA is convening a panel of experts to give it advice on what kinds of studies it should require to determine whether diabetes drugs help the heart, or hurt it. The current FDA requirement, that companies first prove that a new medicine does not create excess harm for the heart and then conduct a study to see if the medicine prevents heart attacks and other heart problems, dates back to a period a decade ago when a series of controversies about unsafe medicines made national headlines.
Reporting in the Proceedings of the National Academy of Sciences, investigators demonstrated in cancer cell lines and animal models that the research compounds - similar to common anti-diabetic agents known as thiazolidinediones (TZDs) - sensitized lung tumor cells to carboplatin chemotherapy. Tumors in rodents treated with the combination of carboplatin and one of the experimental compounds, SR1664, weighed less than those in animals treated with carboplatin alone.
Rare Diseases Patients Need More Than Miracles And Trumpcare
The plaintiff insurers adequately alleged they suffered a concrete injury under the Racketeer Influenced and Corrupt Organizations Act (RICO), Judge Juan R. Sánchez of the U.S. District Court for the Eastern District of Pennsylvania said in a Nov. 9 opinion.
AstraZeneca ($AZN) has made no secret of its intention to deepen its presence in China, despite the country's economic slowdown. And it's not above asking for local help to fulfill its objectives.nThe UK-based pharma group has enlisted the aid of Shenyang-based biopharma company 3SBio to help kick-start two drugs for diabetes. The disease already afflicts almost one in 10 adults in China and is becoming increasingly common as the population adopts a westernized lifestyle.
And that’s final, the U.S. Supreme Court says: GlaxoSmithKline will have to face claims that it conspired to rip off payers by downplaying the risks of its diabetes drug Avandia.