Medication safety issues do get scrutinized, and rightly so. In July 2010, the FDA had a meeting with the Endocrinology and Metabolic Drugs Advisory Committee along with the Drug Safety and Risk Management Advisory Committee. They debated whether to add more to Avandia's black box warning or pull the drug off the shelf entirely. Utimately, they recommended that Avandia stay on the market. The FDA is now mulling over their next move.

So why are we not as diligent in scrutinizing the statistics and methods of evaluation that jumped to inconclusive conclusions? How many people avoided heart conditions by staying on this FDA-approved drug?

Perhaps we just need to change the black box warning: "Avandia can cause or worsen heart failure. So can too much ham at Thanksgiving if you have a weak heart." My personal favorite approach to the Avandia black box warning comes from the Physicians Committee for Responsible Medicine (PCRM) who filed a lawsuit in the U.S. District Court for the District of Columbia. PCRM urges the FDA to require that diabetes drugs carry warning labels that "low-fat, plant-based diets can effectively treat type 2 diabetes without dangerous side effects associated with oral medications." Gotta love that panache. PCRM would have to supply the pharmaceutical companies with henna-embossed lettuce wraps in order to fit that lengthy warning around the pill bottles! (Disclaimer – as a vegetarian leaning towards becoming a vegan, I agree that the science behind a plant-based diet is a powerful tool to help manage diabetes, but It is a tough approach for many.)

I'm not suggesting Avandia is the answer. I'm saying it is one of many medications that help, especially for individuals with insurance plans that don't cover the other similar drug Actos. (This is not an article about comparing which has a better metabolic profile.)

My concern from my clinical practice observations is that our scientific community may have done more harm than good in this debate. It is now almost as rare to see someone on Avandia as it is Micronase. It is frustrating to see the clinical impact this has had individuals who did well on Avandia who were pushed back onto the glycemic roller coaster.

Maybe we should ask how many people were harmed versus helped by stopping their Avandia as a direct result of the inconclusive meta-analysis? Those results are inconclusive too.

EDITOR'S NOTE: The Food and Drug Administration announced that Avandia will be permitted to remain on the market, but under extremely restricted circumstances. READ MORE ABOUT IT.

Read Theresa's bio here.

Read more of Theresa Garnero's columns.

NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition. 


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Last Modified Date: June 19, 2013

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