Avandia Stays On The Market


The FDA ruled today that the diabetes drug Avandia should stay on the market, despite a study that concluded the drug increased the risk of heart attack by 43%.

Since the study was published, Consumer Reports has come out in favor of older drugs:

Diabetes drugs received wide attention last spring when research found a possible link between rosiglitazone (Avandia) and a higher risk of heart attacks. While those risks remain unclear, the CR Best Buy Drug report cites other reasons that rosiglitazone and the related drug pioglitazone (Actos) are not wise first choices for most people with diabetes, including their higher risk of heart failure compared with other diabetes drugs.

Consumer Reports that patients should first ask their doctors about metformin (Glucophage and generic), claiming that the effectiveness of the older drugs are equivalent to the newer ones, but with less potential risk.

The FDA claims that they can’t pull the drug because the research is “inadequate”. According to the Today show the drug pulls in about $3.2 billion in sales per year for its manufacturer, GlaxoSmithKline.

GlaxsoSmithKline’s representative claimed that the drug couldn’t be pulled from the market because “it’s not like there’s a risk-free alternative here.” Risk-free. No. Comparable effectiveness with potentially less risk? Consumer Reports would say there is.

PREVIOUSLY: Consumer Reports: Older Drugs Better For Those With Type-2 Diabetes
FDA Knew About Potentially Lethal Diabetes Drug Since Last August, Said Nothing

Comments

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  1. Ncisfan says:

    That just gos to show how corrupt the FDA is

  2. NKMike says:

    How does this show the FDA is corrupt? The drug has great benefits, unfortunately it also has a bad side effect. I’m glad that the study’s findings were made public so that doctors can consider the newly discovered side effect when deciding on a treatment regiment for diabetes patients.

    Just because it has a bad side effect it shouldn’t be pulled off the market!

  3. timmus says:

    Man, no way would I take any drug that would put me at risk of cardiac arrest. I’d rank that as one of the lamest ways to go. Maybe #2 behind Chinese candy laced with a delicious cyanide coating as a preservative.

  4. mwshook says:

    (note, I’m a family physician)

    When I read the Avandia study that this is all based on, I was shocked that the media was making such a huge event out of this study. It was a meta-analysis of dozens of studies performed on varying populations, some of which didn’t even report any cardiac events or deaths. A meta-analysis can generate a hypothesis, but I would not say this study comes close to proving anything.

    I’ve never used Avandia as a first-line agent. Yes, the other drugs are cheaper, and possibly safer. But they are not alternatives to Avandia, they are used in conjunctions. Most of my patients on drugs in the glitazone class are already on metformin and glyburide before I added it.

    If a person decides to come off of Avandia, that’s a reasonable choice, but that person is probably already on two medicines, and will have to go on insulin.

    The recent Avandia study certainly raises concern, but I’ve seen nothing to warrant it being withdrawn from the market.

  5. bohemian says:

    Most of the older drugs for most conditions are a better first option. They are cheaper and more is known about the side effects. It seems like the side effects on some of the older drugs are also less severe. They also tend to be on the $4 generics list that most of the big box stores have.

    I have very little confidence in the FDA. I had a heart incident on Vioxx, my dad had a stroke due to taking Seldane for allergies.

    What really concerns me is that most of the OTC generics you buy do not state where they were made. Many of the generic drugs are being made in places like India. India might have a safe oversight on drug production, I don’t know. But I would like to KNOW where the pills were made. Heck I get to know where my shampoo was made but not generic Benadryl?

  6. Piquant1 says:

    The FDA warning on rosiglitazone maleate (Avandia) includes its use in combination pills.

    Avandaryl (rosiglitazone maleate – AVANDIA and glimepiride – AMARYL)
    Avandamet (rosiglitazone maleate – AVANDIA and metformin HCl -GLUCOPHAGE)
    [www.fda.gov]

  7. cashmerewhore says:

    Sometimes the risk of the drug doesn’t outweigh the overall benefits. I know people who continued to take celebrex and vioxx despite the warnings for heart attacks & CVAs. Anti-depressants run the risk of making you suicidal. It’s there in the side effects, if you choose to read them.

  8. Wormfather says:

    IMO, the doctor and the patient should be able to talk about the risks and advantages of this drug before they decide if taking this drug is appropriate.

    There are a lot of people with type 1 diabetes that this drug will be wonderful for, now on the other hand, if you’re someone who developed type two diabetes because of poor diet and lack of excersize, yeah, this drugs not gonna work out to well for you.

  9. Wormfather says:

    Oh, and I’m not a doctor…but I did stay at a Holliday Inn Express last night.

  10. IMO, the doctor and the patient should be able to talk about the risks and advantages of this drug before they decide if taking this drug is appropriate.

    @Wormfather: I agree. Diabetes can lead to death if not treated properly (and a lot of ugly stuff before it kills you like blindness) so for some people an increased risk of cardiac arrest might be worth it when other treatments aren’t enough.

  11. “Comparable effectiveness with potentially less risk? Consumer Reports would say there is.”

    FOR SOME PATIENTS. Not all patients react the same way to the same drugs. You want to START the patient on the older drugs and see if they work. If not, Avandia is a good drug to have in your arsenal for use when it is appropriate.

    Incidentally, has everyone seen Celebrex’s new commercials where they bend over backwards six ways to say “We’re not a miracle drug, you should only use us when nothing else works”? That’s how Avandia, if it’s smart, will be marketing. Or not marketing at all.

  12. monkeyboy42 says:

    This is actually one of those times when the FDA is absolutely right. Ask an endocrinologist who is familiar with the study what they think of Avandia, and you will get a very different story than the one being spread in the media furor. For one endocrinologist’s view, check out [www.medicinenet.com]

    Right now, the FDA is not showing its corruption. Quite the opposite, in fact. They are relying on peer review and hard science to make their decision. Like they are *supposed* to do.

  13. Ncisfan says:

    @ NKMIKE & MONKEYBOY42: I looked into Avandia a little bit more and you guys are right.. my bad

  14. pestie says:

    As a diabetic who’s on both glucophage and pioglitazone, and who didn’t have insurance up ’til a couple years ago, I can tell you what the major difference is between these two drugs:

    30-day supply of glucophage: $7.95
    30-day supply of pioglitazone: $400+

    It should come as no surprise that I eventually started going to a Canadian pharmacy, despite the hassles involved.

  15. usamaah says:

    I’m glad that MWSHOO… (4th comment) pointed out that the entire Avandia thing was based on a meta-analysis and was not actually a proper study or experiment.

    I work as a pharmacy technician (so I clearly don’t have the same knowledge that MWSHOOK who is a family physician does), and the pharmacist I work with a good friend of mine, also was a bit annoyed that such a fuss was being made when the information was actually a hypothesis reached via a meta-analysis.

    Some doctors did take their patients off the drug, mainly because the patients were very upset that they were prescribed the drug in the first place (“you’re supposed to be a pharmacy, but you’re trying to kill me!”). Admittedly this was not the majority reaction but nevertheless it is disappointing how the media did no proper research into the matter and ran with the story. They probably thought it was another Vioxx. By the way, my mom still has Vioxx tablets and takes them because the other medications (including Celebrex) do not help her in nearly the same way.

    I also read the Consumer Reports issue which this post mentions and I thought it was a bit ridiculous for CR to suggest that the cheaper generic drugs are equivalent in efficacy. As MWSHOOK pointed out, many physicians begin with the well established drugs and then only move to newer drugs when no improvement is seen. For some individuals Metformin may work just as well, but for others its possible that Actos or Avandia have a much more potent effect in reducing a patient’s blood sugar (usually when combined with Metformin or Glyburide).

    So I think the FDA made the right decision.

    To BOHEMIAN, as far as prescription drugs go you’re free to ask where the generics are made. For OTC medications you can call the phone number on the box and they should be able to tell you where the medication was manufactured. Still, I agree with you that the information should be printed on the box and you shouldn’t have to call. And for the record, most large Indian manufacturers are alright in my opinion, at least when it comes to prescription drugs. Our current supplier of Metformin (as suppliers can change every few months) is made in Ahmedabad, India and our generic Cipro (remember the drug that everyone wanted because it protected you from Anthrax?) is also made in India. For the record I work at a CVS.

  16. LizS says:

    I have a friend who was on Avandia and had a heart attack in her mid-30s. I think it was within 6 months of starting it and a few months before this was announced. She exercises, eats right and had no warning signs whatsoever. She has since moved on to other meds and has her blood sugar completely under control with those.

    Maybe some people think this is a risk worth taking, but I would only consider it if all other alternatives failed.