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Thursday, January 29, 2009

FDA seeking "do over" on popular blood thinner

Article by Dr. Jon Ingilis, Jan 28, 2009

Of all the laboratories, scientists and technology the FDA has at its disposal, it's the one thing it doesn't have that it tends to need most.

A time machine.

America's favorite bureaucracy seems to constantly be in the business of unleashing some health menace on the American public, and then frantically trying to undo it. The latest FDA "do over" effort involves the blood thinner Plavix.

The FDA announced this week that it was investigating Plavix to see if it is ineffective in patients taking prescription medications for heartburn, such as Nexium (you know, the kind of knowledge it would have been nice to have before millions of Plavix prescriptions were written). The investigation comes on the heels of a study that found people taking heartburn meds with Plavix were far more likely to be hospitalized for heart attacks and strokes, which lead researchers to wonder whether heartburn drugs neutralized Plavix.

But here's the crazy thing – heartburn drugs are often being prescribed with Plavix, because the blood thinner can cause upset stomach.

You heard that right – doctors are prescribing drug combinations without any idea of how those drugs will interact. As shocking as that sounds, it happens all the time. Drug companies are not required to study all the ways their drugs will interact with other drugs… they just wait and see what happens.

In other words, Bristol-Myers Squibb Co. and Sanofi-Aventis SA get to sell $7 billion a year worth of Plavix, while the FDA sits back and waits to see if any carnage results.

There was carnage, of course – and it was completely avoidable. I mean, the majority of folks on Plavix are middle age and older – the same demographic most likely to suffer from heartburn to an extent that would require medication.

You didn't need a crystal ball to understand that these two drugs would be taken together. It was obvious, especially given Plavix's ability to upset your digestive system.

It all goes back to what I've been telling you for years – you can't count on government oversight to keep you safe. The FDA's drug review process is broken and dysfunctional. You need to look out for yourself.

If you're on heartburn meds and Plavix, talk to your doc right away. Better yet, if you're on either of these drugs, have a frank discussion with your doctor about whether you really need them. You might be surprised.

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