Internal FDA reports say controversial diabetes drug causes heart attacks, recommend removal (NYT)

[heli]

http://www.nytimes.com/2010/02/20/health/policy/20avandia.html

February 20, 2010
Controversial Diabetes Drug Harms Heart, U.S. Concludes
By GARDINER HARRIS

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks...

[hobbit709]

1. I was on Avandia for two years.

Right after I started using it it was when my circulation problems started. It's improved a bit but still not the way it was before I was on Avandia.

[HysteryDiagnosis]

3. Circulation problems?? Legs perhaps?? I don't understand

how this med could have made it out of the shoot.

[Mari333]

2. glaxosmithkline says it studied avandia yeah right

they have their lawyers lined up in Armani suits right now defending themselves against a huge class action lawsuit.

[HysteryDiagnosis]

4. Strange, they knew almost 30 years ago that statins would diminish

coenzyme q10 production in the liver but didn't add it to the statins even though they had a patent to do so. Now, they put out a drug that affects circulation and don't add anything natural such as horse chestnut or pycnogenol to enhance circulation... once again showing how STUPID they can truly be.

[Yurovsky]

5. exactly... Big Pharma sees patients as ATMs, not human beings...

and when one of the ATMs dies, well, it must've been a defective ATM. Big Pharma would never hurt anyone...

[TreasonousBastard]

6. 300 heart failures a MONTH! That's damn near an epidemic...

and it should be a no-brainer to take it off the market when there are alternatives. Methinks the decision will come when the patent runs out, though.

(BTW, anyone notice that the presumptively evil and widely demeaned Baucus and Grassley are the heroes in this?)

[DonkeyHoTay]

7. Diabetes Meds - Type II

When I was in Japan, a diabetes clinic in Ginza worked out a
meds plan for me which has successfully reduced my blood sugar
to normal levels - - 

Actos late at night (with a half oz of grain alcohol) to
prevent the "dawn phenomenon", Amaryl at mid-morning
after breakfast to stabilize my blood glucose for the day,
Metformin with every main meal.

I have also found that taking 2000 units of Vitamin D each day
is also effective in maintaining consistent control.

It is so important to take meter readings at least two or
three times a day!  If only the test strips could be given out
 free to all diabetics!

For new diabetics, please GOOGLE  "Dr Richard
Bernstein" who is still alive and in practice in New York
State.  His life story and work on effective treatment of
diabetes is a MUST for newly diagnosed diabetics.  
http://www.diabetes-solution.net/

[pleah]

8. I lost a cousin to diabetes at the age of 42.

:(

[c brand]

9. 500 heart attacks + 300 heart failures EVERY month vs. 34 deaths in 10 years for Toyota

and they're still selling this drug like mad!!!