Posted on 05/21/2007 2:42:24 PM PDT by 2ndDivisionVet
The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert Monday.
The Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC (GSK) of London.
More than 6 million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack, according to the review published by the New England Journal of Medicine.
Experts said the overall risk was small and cautioned people not to stop taking the drug on their own but to talk to their doctors.
The company downplayed the report of heart risks, saying the analysis by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic is not definitive scientific proof. In a conference call Monday, Dr. Lawson McCartney who leads Glaxo's diabetes drug development, said the company is not seeing "anything like" the problems reported in the medical journal.
"We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine," McCartney said.
The government will take no immediate action on a label change or other measures regarding the drug, said Dr. Robert J. Meyer of the FDA's Center for Drug Evaluation and Research.
Some data suggests "that there is a potentially significant increase in the risk" but there also is risk if patients switch drugs or do not keep their blood-sugar under control, an FDA statement says.
FDA officials acknowledged that Glaxo submitted information last August indicating some increased risk from the drug but that other studies were contradictory. However, several members of Congress expressed alarm and said they would hold hearings on the safety issues.
Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 18 million Americans and 200 million people worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.
Avandia helps sensitize the body to insulin and was considered a breakthrough medication for blood-sugar control.
Worried patients should not quit Avandia on their own and should discuss concerns with their doctors, wrote Drs. Bruce Psaty and Curt Furberg in an editorial in the New England Journal. Psaty is with the University of Washington in Seattle and Furberg is with Wake Forest University.
However, to the extent that the new analysis shows valid risks, the drug "represents a major failure of the drug-use and drug-approval processes in the United States," they said.
When the drug was approved, "evidence was at best mixed" on its benefit, wrote the two doctors. Both have been frequent critics of the FDA's failure to spot dangers in the drug approval process and its conduct in the case involving Vioxx. The popular arthritis medicine sold by Merck & Co. (MRK) was taken off the market in 2004 when heart problems came to light after it had been taken by millions of people
Several experts said Avandia was another example of the FDA failing to detect a safety problem early enough.
Glaxo's shares trading in the United States fell $3.85, or 6.6 percent, to $53.89 in afternoon trading.
The report on the diabetes drug's risks follow Glaxo's $2.5 million settlement of a lawsuit filed by former New York Attorney General Eliot Spitzer over the release of data on the safety and effectiveness of its drugs. Spitzer, now New York governor, accused Glaxo of fraudulently withholding some results of studies that had examined the safety of prescribing the antidepressant Paxil to children.
GlaxoSmithKline disputed that it attempted to mislead anyone, and said it has always been in favor of widespread disclosure of clinical trial results.
The company's clinical trials registry () is available to the public, although the reports within it are highly technical and may appear incomprehensible to an untrained reader.http://ctr.gsk.co.uk
Meadow Muffin
thanks for the posting. I love being one step ahead.
This situation reminds me of that surrounding the drug called: “Progenitoravox”. (Eyeballs pop from sockets, etc.)
So, by reducing the effects of diabetes on some individuals, the risk of specific complications is increased for others....
There is no one panacea for everybody. And that is why the practice of medicine is PRACTICE, and it is an art as much as a science.
Why aren't they held accountable for approving these drugs? Class action suit against the manufacturer soon to follow.
And so it is with every drug on the market. I would never put any drug in my mouth without thoroughly investigating it and its side effects first.... being informed of how it works and what the sign's and symptoms are of those side effects.
Oh my. Your husband’s situation sounds exactly like my husband’s. Mr. RR has had three by-passes. Type II diabetes, barely controlled hypertension, etc. etc. He has taken Avandia and Metformin (Avandamet) for years for the diabetes. He will call his Dr. in the AM to see what he recommends. Even with strict diet control and lots of excercise, he has problems with the glucose level. The cardiac problems are just an added concern.
Metformin works for me and I’ve never had a Dr suggest it was not up to the job.
Thx for the info
Sheesh! My Doctor just switched me to Advandamet, and I took my first dose just this morning!
...of something, some day...
“Yer gonna DIE!
...of something, some day...”
Yeah I know, but I was pretty sure it was going to be from either terrorism, global warming or “immigration reform” (not meaning to discount Hillary 08).
Thank God. I’ve been trying to warn against this drug for years. Took it once for a couple of months and had just awful side effects, chest pain, muscle weakness, fatigue, etc.
No one believed me. I stopped on my own and got ok. I even wrote to the FDA about it, but no response.
Now that I’m suffering from some of the side effects of reading about Panexa, maybe I need some Progenitorivox as an antidote:
http://www.youtube.com/watch?v=mYodDH4qZQo
That’s very interesting. My husband has been on Avandamet since he was diagnosed with diabetes and, even though his sugar and blood pressure readings are book perfect, he’s always extremely tired. I wonder why his doctor did not put him on Metformin first! I think I need to call the doctor first thing in the morning.
I take Glyburide /Metformin and Avandia.
I commented to my doctor that I had cut down on calories and should have lost about 6-8 lbs,but had only lost 3 pounds. He told me Avandia stores ??? in your fat tissues and people who take it can gain weight.
Today's solution is tomorrow's problem. - tom
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