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
Not surprising at all to find this kicks the heart attack rate skyhigh.
Same thing goes on with Glucophage.
I hope you do. It not only can cause all the side effects I mentioned, but also severe swelling. Now I just take a 500 mg glucophage daily, 1/2 a 2.5 mg glyburide daily, maxide daily and my glucose is nearly normal all the time. Eating pretty much what I want, but careful of portion size.
Metformin (generic) really upset my system, so I switched to the real glucophage (more expensive, but worth it) and most problems are gone.
I didn’t know there was a difference between Glucophage and Metformin. I also didn’t know I could get refills at Wal Mart for $4...
Everything points to big money ahead for somebody since this is starting to happen more frequently.
Cardiac problems and diabetes are both symptoms that can be related to insulin resistance. We believe, and there is evidence to support our belief, that much of this is caused by too much polyunsaturated fats and too much grain, especially wheat, in our diets. The only safe cooking oil is coconut oil, a medium chain saturated fat (lauric acid is most of the fat in coconut oil).
Polyunsaturated fats, also known as Omega 6 fats, are found in corn oil, soybean oil, canola oil, along with numerous other vegetable oils. These should be eliminated from our diets.
Olive oil, by the way, is “neutral”. We should not cook with oilive oil, but it is good for salads.
Butter is also okay. Margarine is bad for us. Butter is okay in moderation for cooking.
If you want to use a polyunsaturated oil as a food, it is worthwhile to remember what its effects are: it suppresses metabolism and promotes obesity, is immunosuppressive; causes inflammation and shock; is required for alcoholic liver cirrhosis; sensitizes to radiation damage; accelerates formation of aging pigment, cataracts, retinal degeneration; promotes free radical damage and excitoxicity; causes cancer and accelerates its growth; is toxic to the heart muscle and promotes atherosclerosis; can cause brain edema, diabetes, excessive vascular permeability, precocious puberty, progesterone deficiency, skin wrinkling and other signs of aging.
Why should you be using coconut oil versus any other type of oil? Because it can:
· Help you lose weight, or maintain your already good weight
· Reduce the risk of heart disease
· Lower your cholesterol
· Improve conditions in those with diabetes and chronic fatigue
· Improve Crohn’s, IBS, and other digestive disorders
· Prevent other disease and routine illness with its powerful antibacterial, antiviral and antifungal agents
· Increase metabolism and promotes healthy thyroid function
· Boost your daily energy
· Rejuvenate your skin and prevent wrinkles
I have been on it for four years and no heart attacks so far. I’m not really worried about it. In fact, if I keel over and die tomorrow I am comforted in knowing that now my sisters have somebody to sue.
BTW, if the drug was approved by the FDA eight years ago, that means you can place the blame on the < whisper > Clinton Administration < /whisper > but of course none of the news reports will ever mention that.
thanks for post; I’m printing out for my mom (she takes Avandia)
When I first started on Avandia, my weight went up and my glucose levels were still too high. What changed it was when I went to exercising (mostly long walks) for an hour every other day. The first 15 minutes are not useful but the body soon switches to the long-term reserves which burn off excess sugar. Originally, the doctors suggested a half-hour of exercise every day but I found an hour every other day is easier to fit into my schedule and the benefit is even greater.
Since that adjustment almost two years ago, my blood sugar tests all come back well and my weight stays neutral. I eat pretty much whatever I want although I’d already cut out some things like sodas and burgers many years ago.
There’s not supposed to be any difference, but Metformin is the generic version of glucophage and for me, the generic just doesn’t work as well.
Rosiglitazone and Cardiovascular Risk
Those are links to the original NEJM article and the accompanying editorial, respectively. You may have to register, but they are FReebies.
Along with Type II Diabetes, she'd been diagnosed with having her carotids occluded 85%. Because of her memory problems, she hadn't been taking her glucophage, lipitor and blood pressure meds on a regular basis. She had no medical insurance, didn't qualify for Medicaid and at 60yrs old, Medicare was out of the question. We took the situation in hand and stabilized her blood sugars/blood pressure by diet and specific supplements. Coconut oil was one of the things we put her on.
It's been two years now and she's off all her previous meds, has lost 50lbs and is physically better than she's been in 20 years. It's amazing. The recent doppler showed that she had 95% of her carotids operating....so she won't have to have the surgery.
Six of the 48 trials did not report any myocardial infarctions or deaths from cardiovascular causes and therefore were not included in the analysis because the effect measure could not be calculated.
In plain English, for the patients taking the diabetes drug they ONLY considered those who had some type of heart complication, they did not consider the others. It's like my 12-year old who can run a 5K in 21 minutes... if I decided not to consider those runners who can finish in 20 minutes or less, that would probably put him in the top 5 for most races, but the fact would still remain that many people had run with better times regardless of whether or not I include them in my final analysis. So, if we eliminate those groups where the drug does not have a detrimental effect, that skews the results against the drug, but how real are those conclusions? I'm amazed that a pier-reviewed journal of the status of the NEJM would publish such pseudo-science!
Thank you so much for your post. I try to read and adjust as much as he will accept, but I must admit that I thought coconut oil was a no-no. I can’t wait to try it. I might gain some benefits too. thanks again.
The heart disease and diabetes are more complicated when they want to change some of his medication. I hate it. It takes a while to see how they will affect him, interact, and whether or not it will work. Then when you add anxiety, depression, high blood pressure, water pill, stomach pill, cholesterol, etc, etc.
I’m glad I have him around and no amount of pills is too much trouble. but I’m going out tomorrow and buy some coconut oil. Every little bit helps, and hopefully he won’t notice any change.
Doc had me taking Glucophage, first 1/2 a pill. then 1 then 1 1/2, then 2. It got so bad these side effects that I could not keep my sugar level up for more than an hour, It would plummet down to the low 40’s and I almost almost lost my vision and I was having to eat all the time just to keep it above seizure stage. Took myself off all meds3 yrs ago, thyroid, diabetis and high BP. Now all bloodwork is normal and under control with diet and alot of exercise and I no longer need glasses. Funny the doc still thinks I am taking all that Medication.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.