FDA review spotlights heart risk of diabetes pill (Avandia)

Washington Post ^ | July 10, 2010 | MATTHEW PERRONE

[neverdem]

The Associated Press

WASHINGTON -- Federal health scientists have panned a GlaxoSmithKline study that the company used to defend the safety of its embattled diabetes drug Avandia, a once blockbuster-seller that has fallen out of favor because of potential ties to heart attacks.

The Food and Drug Administration posted an exhaustive 700-page review of Avandia on Friday ahead of a meeting next week to decide whether the drug should stay on the market.

The FDA finds itself in a difficult position that's all too familiar: reviewing a drug approved a decade ago that now appears tied to deadly side effects. Experts say the FDA's predicament is a result of shifting standards for the agency: increased scrutiny on safety and stepped-up pressure from Capitol Hill...

[Dubh_Ghlase]

NG! I took this for several years...! (Gulp!)

[goodwithagun]

Didn't the FDA approve this drug to begin with? Sheesh. Glad I turned to alternative medicine a few years ago. Since then, I haven't had to deal with meds that cause explosive diarrhea and sudden death.

[muawiyah]

Determining cause and effect with Avandia is quite difficult. Many physicians (probably almost all of them) thought it a good idea to prescribe this drug to their diabetic patients who used both Glipizide and Glucophage ~ the constituent parts of Avandia ~ to reduce the effort they had to make to deal with their diabetes.

Those who didn't have heart trouble were probably not administered Avandia if they had no other problems.

FDA had to back that out of the equation to come up with this recent finding.

My own thoughts are that simply taking Glucophage and Glipizide at the same time is probably not that neat an idea anyway. Both drugs contain ingredients that "talk to the nucleus", and that's gotta' have some unknown effects, plus the Glucophage works, in part, by blocking the passage of both starch and B-12 across the membranes in the small intestine. It probably screws around with other stuff anyway.

I expect the very next FDA report on these two drugs is going to be to avoid using them simultaneously.

[snippy_about_it]

Did you switch to alternative medicine for type 2 diabetes?

[CaspersGh0sts]

“Sheesh. Glad I turned to alternative medicine a few years ago.”

Better watch your liver. I’ve seen several people go the “altnerative route,” only to realize their alternative herbs were destroying theirs.

The best means of dealing with diabetes is, of course, to lose about 20 pounds. Lots of natural things help, like fish oil, cinnamon, and vinegar. I’d encourage this route to my patients before going the med route.

Just realize that “alternative” doesn’t necessarily mean better or safer.

[goodwithagun]

No, I had a problem with systemic candida. I didn't realize I had it for about four months. I was nursing and just thought it was supposed to feel painful. Finally the exterior symptoms erupted and my doc gave me a script for a one week regimen of Diflucan. BTW, one Diflucan is prescribed for vaginal yeast infections. One pill only. This didn't work so she put me on a two week regimen. This did not work so she put me on a two week loaded dose. This also did not work, and I really freaked out when she told me I had to get a liver test because anti-fungals can permanently damage the liver. Great! I found a natural health expert, he put me on a natural regimen and I was much better after a week and cured after about three months. No liver damage this way, by the way. The natural regimen actually bolsters liver function. After that experience I decided to take the natural approach for my polycyctic ovarian syndrome. Because of PCOS I had to take dangerous meds to conceive. For the first time in my life I have a normal cycle and I have ovulated every cycle except for one. That happened to be a very stressful month. Alternative medicine is not for everyone, but it is for me.

[neverdem]

Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone (Avandia and Actos, respectively)

Rosiglitazone and the Case for Safety Over Certainty

Recommended Blood Pressure Level Differs For Heart Patients With Diabetes

FReepmail<< b>FReepmail< /b> me if you want on or off the diabetes ping list. /b> me if you want on or off the diabetes ping list.

[upchuck]

Avandia: not on my to do list.

OT: Interesting story about surgical weight loss and Type II Diabetes:
http://news.yahoo.com/s/ap/20100707/ap_on_he_me/us_med_diabesity_surgery

[annelizly]

a few years ago they gave this to my mother and it gave her congestive heart failure symptoms...the doctor refused to believe us. we agonized over it and finally she decided to take herself off of it and symptoms disappeared. a year after the doctor convinced her to start taking it again and AGAIN congestive heart failure! Finally she quite taking it all together...a year or so later she died from heart related issues.

I really wonder if this crap weakened her heart so badly that it killed her anyway.

[neverdem]

Many physicians (probably almost all of them) thought it a good idea to prescribe this drug to their diabetic patients who used both Glipizide and Glucophage ~ the constituent parts of Avandia...

That's not so.

Approximately 10 years ago, the thiazolidinediones rosiglitazone and pioglitazone were introduced for the treatment of type 2 diabetes. Like their forerunner troglitazone, which was removed from the market following reports of hepatotoxicity, these drugs act on the gamma subtype of peroxisome proliferator-activated receptors (PPAR-gamma) in the cell nucleus, resulting in heightened insulin sensitivity and improved glycemic control.

Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Sulfonylureas like Glipizide increase the amount of insulin released by the pancreas.

[neverdem]

Thanks for the link.

[muawiyah]

Uh, which part ~ isn't Avandia merely a one shot pill replacing the other medications ~ creating what is supposedly a more controllable flow of both?

Or do you dispute how Glipizide convinces the beta cells to yield more insulin?

I only read the latest articles on this stuff, so maybe I missed some of the older theories.

An inlaw using both Glipizide and Glucophage encountered instant congestive heart problems with the veryfirst use of Avandia. His hospitalization lasted several weeks.

He's back on the old stuff ~ it's far less deadly!

Recently I've substituted insulin injections for glipizide, and that also reduced my glucophage need as well.

BTW, remember to use your B-12 pills.

[neverdem]

Uh, which part ~ isn't Avandia merely a one shot pill replacing the other medications ~ creating what is supposedly a more controllable flow of both?

No, there are combo oral diabetes meds, but Avandia isn't one of them. Avandamet is a combo of Avandia and metformin, i.e. Glucophage. That's why I linked the mechanisms of action for the thiazolidinediones and metformin. They are completely different.

Or do you dispute how Glipizide convinces the beta cells to yield more insulin?

No

An inlaw using both Glipizide and Glucophage encountered instant congestive heart problems with the very first use of Avandia.

Read the JAMA editorial, "Rosiglitazone and the Case for Safety Over Certainty," that I linked upthread. The gamma subtype of peroxisome proliferator-activated receptors are expressed in the nephrons of the kidney causing retention of sodium and water.

[muawiyah]

Thinking of "metaglip" ~ prescribed frequently along with Avandia.

Obviously Avandia has it's own troublemaking potential.

[Pining_4_TX]

http://junkfoodscience.blogspot.com/2007/01/junkfood-science-weekend-special.html

http://junkfoodscience.blogspot.com/2007/08/was-this-really-proof-that-bariatric.html

http://junkfoodscience.blogspot.com/2007/02/why-we-never-hear-why-people-dont-talk.html