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Posts with tag PopularDiabetesDrug

Diabetics taking Avandia caught in volley of debate

For those of you following the Avandia story in the news, you're probably wondering how the patients currently taking Avandia are feeling. Are they flushing the pills down the toilet? What about the patients enrolled in GlaxoSmithKline's current Avandia clinical trial -- are they dropping out like flies? If you are unfamiliar with the Avandia debate, news broke last week that Avandia, a popular diabetes drug, may increase the risk of heart attack. A 43% higher risk.

It may depend on the specialty of your doctor. BusinessWeek has reported endocrinologists tend to be more skeptical of the study, noting its weaknesses compared to original, more rigorous clinical trials. Many cardiologists and drug safety experts give the study more weight, and remain worried about Avandia's potential cardiac danger. Doctors on the frontline are concerned patients may stop taking the drug without medical consultation as many are confused and frightened.

Dr. Nissen, the whistle-blower on Avandia and leader of the fight to withdraw Merck's arthritis drug Vioxx due to safety issues, acknowledges there are real limitations in his analysis, but he points out Glaxo's own data found a 30% increase in the risk of heart attack from Avandia. Nissen was alarmed enough to release his meta-analysis showing a 43% increased risk versus waiting for the results of Glaxo's 4,400-patient, eight-year clinical trial named RECORD, which is specifically measuring cardiovascular outcomes of Avandia.

Critics say Nissen went too far out on a limb this time as a meta-analysis examining 42 Avandia trials with varying research methodologies is not terribly reliable.

Continue reading Diabetics taking Avandia caught in volley of debate

Avandia controversy stirs Congress to investigate FDA

Remember learning about "checks and balances" in U.S. History class? When state leaders gathered in 1787 to draft the Constitution, they established three branches of government (legislative/executive/judicial) to protect individual freedom and prevent government from abusing its own power. Now, Congress is questioning the balance of powers over at the Food and Drug Administration (FDA).

Republicans and Democrats in the House and Senate have called for an investigation into the FDA in the wake of the New England Journal of Medicine study which suggests the popular diabetes medication, Avandia, significantly increases the risk of heart attacks. A House hearing is set for June 6.

Original trials by the drug's maker, GlaxoSmithKline, revealed twice the rate of ischemic heart disease for patients taking Avandia versus recipients of placebos. The medical reviewer for the FDA initially expressed concern, but determined the risk was more benign following further analysis.

Continue reading Avandia controversy stirs Congress to investigate FDA

Popular diabetes drug Avandia poses heart attack risk for type 2 diabetics

When my mom was first diagnosed with diabetes in the late 1990s, her internist prescribed Rezulin, a popular diabetes drug approved in 1997. Then one day the phone rang. Her internist called to alert her Rezulin was causing fatal liver failure and he wanted her off the drug immediately.

Now Avandia, a popular diabetes drug which helps sensitize the body to insulin, is on the hotseat. A recent study published in the New England Journal of Medicine by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic suggests Avandia significantly raises the risk of heart attack for type 2 diabetics.

Nissen pooled results of nearly 28,000 people across dozens of studies, revealing a 43 percent higher risk of heart attack for Avandia users compared to diabetics prescribed different drugs or no diabetes medication at all. Two-thirds of type 2 diabetics die of heart problems. With a 43 percent higher risk, Avandia may be downright dangerous.

GlaxoSmithKline PLC, maker of Avandia, disputes Nissen's analysis, but admitted a similar review revealed a 30 percent increased risk. I don't know about you, but a 30 percent higher risk of heart attack frightens me. Glaxo did say further rigorous studies did not confirm an excess risk.

I suspect the phones will soon be ringing in the homes of Avandia-prescribed type 2 diabetics. And it's not good news.

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