F.D.A. Says Millions Got Unapproved Heart Pills

[alp227]

Source: The New York Times

Doctors in the United States wrote more than four million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce the chest pain angina or to stop a heart attack.

But the majority of the drugs sold had not been approved for sale, nor had their safety and effectiveness been vetted, by the Food and Drug Administration.

And many doctors, who discovered only last week that pharmacies were giving their patients unproved heart tablets, now say they have no way of knowing whether patients have suffered unnecessarily as a result.

Read more: http://www.nytimes.com/2010/03/27/business/27nitro.html

[midnight]

1. I thought was the reason we couldn't get our medications via canada?

[havocmom]

2. Yep, not safe they said. No way to assure purity they said.

We won't be getting as much $$ from you is what they meant. They don't give a tinker's damn about safety or purity.

[tblue]

3. Dammit. I gotta check what my mom is taking.

Nitro has been prescribed forever. What next? Isn't gov't supposed to oversee this stuff?

[urotsukidoji]

4. That's not entirely correct.

The crafty (mis-)wording of the article lends itself to misinterpretation.

Don't misunderstand...it's only the efficacy of the nitroglycerin TABLETS that missed scrutiny. Impure/poorly manufactured drugs are often worse than no drug at all. That Canada cannot be trusted to produce chemically pure compounds is the line we're being sold. (Statistically, that's total bollocks, BTW).

The drug itself still has the same (very useful) effects, physiologically...it's still the best vasodialator to combat anginal pain and congestive heart failure.

Seriously, DO NOT encourage your family members to stop taking nitro when they need it. (!) DO have them all start writing letters to their government to do their d*mned jobs properly.


The only story here is that the FDA has once again failed us entirely.

[BlueIris]

5. Five posts total?

You should post more.

[Dappleganger]

6. Welcome to DU!

:hi:

[BumRushDaShow]

7. Not quite correct either

This as well as many other "old" drugs were "grand-fathered" in via the http://en.wikipedia.org/wiki/Kefauver_Harris_AmendmentKefauver-Harris Amendment">Kefauvrer-Harris Amendment to the Food, Drug, and Cosmetics Act as they were being used before this amendment was enacted in 1962. Thus they were not required to submit New Drug Applications (including clinical data, etc) to allow their continued use, but would need to provide some sort of data to prove their effectiveness. More recently, a decision was made to go back and start enforcing the requirement for such data on those grand-fathered drugs that still had not provided data.

Now enter 20 years of (non-contiguous) repukes in the White House and 12 years of repukes and/or DINOs running Congress (with 8 years where the repukes controlled it all), and this combo essentially destroyed the agency with a lack of funding to bring on the staff necessary to review what would be an avalanche of ANDAs for those remaining drugs. As a sidenote, the agency had and still has MOUs with Canada regarding pharmaceuticals.

The only thing that failed you were repukes and the DINOs who work with them, so re-direct your frustration to the source.