[09-23-2010] The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
…And Avandia has been completely banned in Europe.
I saw that on the news this morning at 7am Central time.
Actos (pioglitazone) is also under review by the FDA for possible links to bladder cancer. See Wall Street Journal, September 20, 2010: “FDA Reviewing Safety Information on Actos”. Takeda is now at the half way mark in a 10-year post-market study of its drug. The FDA said there was “an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.”
In studies Actos was associated with a decreased risk of cardiovascular events and/or all-cause mortality compared to Avandia. But the results of Takeda’s post market study have now been released so there likely will be some changes in the warnings issued by the company and the FDA.
Here is a decent and interesting article titled – “Why the EU banned Avandia but the FDA didn’t”
It was published today (sep.24th) at CNNmoney
The article also has some mention of diabetes drug Actos.
I believe this was Banned from our local hospitals over two years ago I’m not sure if the state stepped in or if the local Doctors saw the writing on the wall and just pulled it, but it’s gone from this portion of Massachusetts.
I stopped taking this medication about 3 years ago - just prior to all of the studies being released about stroke etc. I quit taking it, because I started experiencing chest pains. So am truly concerned for anyone that does take this medicine
i am taking avandia. last time i discussed this with my dr. she felt that as long i wasnt having chest pains it was ok to continue. im sure this will impact her decision and i will have to change my meds. im also on byettta, 2x a day. i have to say the avandia did help me. looks like a new med on the horizon for me !
Hmm-so this is why they are telling us not to buy drugs from Canada?All the Lipitor is made in Ireland so now they can kill us wiht stuff made here exclusively???thanks alot
I take this all as support for the restricted carb diet option.
I have been battling the “eat NORMALLY??[whatever that means] and use multiple medication” approach for several years. Yes I know not everyone can manage their diabetes by diet alone, but I think many more can reduce their need for medication and thus their risk.
I was recently shown some advice from the British Diabetic Association from 1959, which said to restrict carbohydrates to no more than 100grams per day.
the informaion I havew not yet found, is what the rate of complications was in those days.
I totally agree with you on this. I do not take any diabetes meds except insulin for I am a type 1 diabetic. I have been mostly out of control on BS for the past 40 years. I recently read Dr. Bernstien’s Book Diabetes Solutions which promotes even lower carb diet than the 100 g. I went on the diet 3 weeks ago and my hard to control blood sugars have totally normalized. I take basal insulin but most of the time need very little rapid action insulin for meals. I wished someone anyone had told me about this before. I eat less than 30 g of carbs per day and the highest bg I have had is 160mg/dl.
I have been a Bernstein fan for a number of years. Along with David Mendosa.
This statement means so much to me. What is the fate of those who consump this drugs in subsaharan Africa either as donations or sales by agents. This product Rosiglitazone and Pioglitazone are of same class. They are highly available in the market. Let us avoid preventable complications.
It gives me a funny feeling to read about Avandia and it’s higher risk profile for heart problems. My father was taking the drug when he had a heart attack.
Through the years there has always been a problem with oral drugs for Diabetes. If asked I would say put Type 2s on insulin when they start having problems while on pills. By going from pill to pill their complications only get worse…
Thanks. Very helpful.
How do you keep your weight up? I too have been an IDDM for almost 40 years and although I prefer a lower carb diet to keep blood sugars stable, I lose too much weight. I often drop down to below size 4 (too thin) - my goal is to stay at about a size 7/8 - which I have been unable to accomplish in recent years, since I have removed almost all food that is packaged, has chemicals, preservatives, food dyes, etc. I was on insulin pump for 10+ years, which made carb counting and insulin coverage for food fairly simple. But due to having to switch my expired Disetronic pump to Medtronic (MedT company is a nightmare to deal with) -I took myself off the pump and now take Lantus shot 1x/day + use an insulin pen to cover carbs everytime I eat. It is difficult “guessing” carb amount in home baked and bakery goods (packaged food labels make it easier) But it’s hard finding packaged, labeled food that is all natural- I do feel like a pin cushion with frequent Humalog via pen shots - To maintain my weight I need to eat at least 200gms carbs- probably closer to 300 gms. R those here that are eating 100gm or less carbs aiming to lose weight? As for Avandia and other similar type drugs, I don’t know why anyone would chose to take chemical-laden pills that almost always have significant dangerous side effects. The insulins on market today are very pure and safe - PILLS ARE NOT.
I put my foot down already. I told my docs whem metformin fails insulin is next
Honestly, I think it needs to be banned completely from the market… And I feel people ought to low carb, until they can’t keep good control anymore, and then just go on insulin. These meds are hella scary and dangerous and they just give people more complications than the frigging Diabetes itself. We are like these willing, idiot sheep, going into the slaughterhouse every time we passively agree to taking more and more dangerous meds. It’s unreal. Until they come up with safe medications I’m not gonna bother… No carb is worth more to me than my life. Then people don’t wanna get on insulin, either, thinking somehow those pills are better… ffs! It’s so frustrating.
Just want to say that I agree with you about the prevailing approach of eat whatever you want, whenever you want, and balance it out with a scary combo of drugs. I never thought I would be able to give up eating candy, cakes, bakery items etc yet found, quite quickly, that the longer I was away from that stuff the less appealing it seemed. I do get my moments of craving something but can ride those out. I think many of us are intimidated by the idea of a new diet… but with a little practice, some forethought and shopping, it gets to be a routine and isn’t as insurmountable as it may have seemed. And, guess what, you start feeling kinda good too! I am on Metformin and a good diet. I have yet to see fasting numbers below 100 but they leveled out at least. Try the restricted carb diet approach, it’s the best medicine, no matter what else we’re taking.