As I wake up and read about the news of Actos (from Eli Lilly) joining Avandia (from GlaxoSmithKline) in getting a safety warning from the FDA.
When I see all the politics around this, I cannot avoid wondering what do you guys think? Anyone here taking any of these? How does this make you feel? Do you feel there’s anything that could have been done earlier? When I read this other article, where the the incoming president of the ADA argues that he had been pressured by officials at SmithKline Beecham, I start to think that there could have…
Actually, I think the biggest issue isn’t politics, it is the way the FDA is funded. Basically, in the words of The Boston Globe, "… in 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay “user fees” to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process. In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.
Unfortunately, Congress got very used to the FDA being largely self-funded, therefore they have given little money to the FDA to ensure public safety. This applies not only to drugs, but also to our food. Last year, there were several prominent outbreaks of eColi in spinach and other vegetables that are supposed to be managed by the Food and Drug Administration.
Insulin users are not immune to these problems, either. Did you know that the FDA requires no batch testing of insulin made via rDNA technology? The U.S. Patent and Trade Office filing for Humulin shows that potency of insulin made via synthetic processes can vary by up to 20%. It can be managed, but do you really want a for-profit business to police itself? There are only 3 companies selling insulin, so your choices are pretty limited. While I don’t believe there is a conspiracy theory, I do believe that regulators should be working for public interest, not the needs of the drug industry, but thats not the way it now works.
I actually sell Actos and wanted to share with everyone that this warning on edema and CHF has been in the Actos and Avandia label since 1999, when both drugs were put on the market. It says in plain text under “Warnings” that TZDs can or may cause edema and exacerbate Congestive Heart Failure, and says to not give to patients with CHF Class III or IV. Takeda Pharmaceuticals (the actual manufacturer of Actos and who I work for) and Glaxo Smith Kline have been in talks with the FDA about making this a “boxed” warning to heighten the awareness of this. This is based on no new data, only emphasis on the warning that already exists. TZDs caused edema in only about 7% of patients in initial trials. Physicians are always warned about this and some physicians do not comply. This is why the FDA has made these already existing warnings a “boxed” warning.
Also, I want to make clear that this is not a result and is a separate issue from Dr. Nissen’s meta-analysis in the New England Journal of Medicine regarding Avandia’s MACROVASCULAR COMPLICATIONS. The FDA recently changed the label of Actos’ Prescribing Information to include the first and only outcomes study on a TZD. Over 5,000 patients with Type 2 diabetes and a history of cardiovascular disease (heart attack, stroke, acute coronary syndrome, etc.) were studied for over 3.5 years. These were very sick patients. Actos was shown to have no increase in mortality or macrovascular events. The FDA felt that this evidence was so compelling that they changed the PI for Actos. Actually, if you look at the PI, there is a table in there to show the results from both arms of the study. Actos had less “events”, including death, heart attack, stroke, etc.
So I hope this makes patients taking Actos feel better! As an Actos sales rep, I am going out everyday, pounding the pavement, making sure all physicians and patients feel comfortable taking Actos. We hear worries since these drugs are in the same class, but look at it this way: You have in front of you identical twins. They look alike, may even act alike, but their fingerprints are what keep them different. Actos and Avandia are PPAR agents and each one has a different molecular fingerprint.
I took Actos for about 8 or so months. I can’t say it did me any good, but I can say that it caused me to gain a considerable amount of weight! Nothing else had changed. My diet and all was the same as it had been. I took myself off it finally, as I dont’ have insurance, and it costing me $130/month, and I didn’t feel it was doing me any help. I was right!
My dad was on Avandamet, he too gained alot of weight, and had an acute pulmonary edema attack, just after a surgery to manipulate his shoulder. He nearly died!! Was on a ventilator for a couple days … barely hanging on! I will go to my grave saying that the Avandamet is was brought that on!
Not that I need them, but I’ll NEVER take Actos again, nor will I EVER take Anyting Avandia.
Just my experiences and feelings. I know things work/react differently with each of us. Some have had very good luck with these meds. I’m just not willing to take that risk.
There’s even worse news that just showed up today–a study that had been published in Diabetes Care on May 29, but only in an abstract form that didn’t make clear what its results meant. Turns out that 1 in 50 people taking Avandia AND Actos were hospitalized for heart failure and the data makes it look like the drugs are causing heart failure in relatively young people who did not have it to start with.
This shouldn’t be a surprise. These drugs pack on huge amounts of water weight on people and this probably stresses the heart.
If nothing else, this should really be a wake up call to all of us to keep up with the research about any drug we are taking. I was writing about the edema issue with these drugs in 2003 because the studies had already been published flagging the problem.
I am taking Actos and Glipizide. I haven’t had my problems with the medications themselves and my last tests were all great, other than the weight gain! I was a big guy to start and even with watching what I eat and exercise it keeps adding on! Anyone have any tips on overcoming the medications weight additions?
Seems like the pressure is helping. Read this excerpt from a piece of news posted on CNN Money this morning:
"NEW YORK (Associated Press) - Government regulators are reconsidering how they approve diabetes drugs. They were criticized last year for their handling of heart risks connected with a widely used GlaxoSmithKline pill.
The Food and Drug Administration will hear from diabetes experts, cardiologists and statisticians at a two-day meeting that begins Tuesday. A panel of outside experts are expected to weigh-in on whether drug companies should be required to show that their drugs reduce heart problems and death to win FDA approval.
If FDA adopts such a standard, companies like GlaxoSmithKline, Merck & Co. Inc. and Takeda Pharmaceuticals could be forced to conduct expensive, multi-year studies previously not required of diabetes medicines.
FDA has traditionally cleared drugs for type 2 diabetes, which represents 90 percent of all cases, based on their ability to control blood sugar levels. But the value of that criterion was questioned last year after an analysis of GlaxoSmithKline’s Avandia showed it increased heart attack risk, despite lowering blood sugar."
Avandia here. Somewhat worried, but have known for a couple of years. It (in combination with Metformin) is so good for me in terms of control that it is difficult to think about trying something else. My doctor was really hoping to see more studies and better numbers before making a recommendation. He will let me make the decision if I want, but I figure I’m taking a bigger chance every time I get in an automobile …
I took Actos for several years getting up to the highest dose possible. It caused me alot of weight gain and fluid retention so I ended up having to take Lasix and K+ to get rid of the fluid. A new doc and now taking Januvia and Metformin, I no longer have to take the water pill, no more fluid retention and I lost 23 lbs. no more Actos for me.
Wow. I have gained some weight this year, despite keeping to my normal routine, and had to fight like heck to keep it off. I have also been on Actos this year. I wonder if it related or not? I guess I need to read the package inserts and talk to my doctor.