Avandia

In this week’s blog I am going to talk about a medication that was once the most popular medication for type 2 diabetes, but is now very rarely used due to severe side effects.  I’m including it because it is still available within the United States and I know that some patients are on it so they should be aware of how it works and exactly why its use is so heavily regulated.  This week I will be discussing the diabetic medication Avandia.

How does it lower blood sugar: Just like Actos that I discussed in last week’s blog, Avandia is a TZD.  For a refresher on all of the classes of diabetic medications, look at my previous blog here.  Avandia works by helping your cells recognize insulin, the hormone that helps push glucose from your blood and into the cell.  Remember, we don’t want large amounts of glucose floating around in your blood, because that causes problems all over the body.

The effect on your numbers: We usually see a patient’s A1c lowered by 1-2% with Avandia (for example, an A1c of 8.6 could go down to 7.6 or 6.6).  However, it does take at least 4-8 weeks to see an intial change in your A1c, and it might even take up to 16 weeks to see Avandia’s full effectiveness.  Another number that Avandia affects is weight, especially if the medication is taken with insulin and certain other diabetes medications.  Patients can gain up to 12 pounds or more.

Dosing: Avandia is started at a dose of 4 mg taken once daily (or 2 mg taken twice daily if preferred).  After 2-3 months the dose can be increased up to 8 mg taken once daily (or 4 mg taken twice daily if preferred).  This is the maximum dose of Avandia.  Avandia may be taken with or without food.

Side effects: The two most common side effects of Avandia are edema (a fancy word for extra fluid that accumulates in your legs, ankles, feet, etc) and weight gain.  In very rare cases, Avandia can cause problems in the liver and eyes.

But the most severe and worrisome side effects of Avandia have to do with the heart.  These side effects include chest pain, congestive heart failure, shortage of bloodflow to certain areas of the heart (known as ischemia) and brain (causing stroke), and heart attack.  Some studies have shown that patients on Avandia are at a 30-40% increased risk of having a heart attack versus diabetic patients not on Avandia.  These major side effects have led to much discussion, studies, and a final decision by the Food and Drug Administration (FDA) in 2010 that influenced the future of the once-popular diabetic medication.

The RECORD and TIDE Trials and the FDA Decision: In 2007 the New England Journal of Medicine published an article based on a cardiologist’s analysis of previous research trials.  He had determined that Avandia increased heart attack risk by 43%.  Because of all of the criticism about their drug, the makers of Avandia (the drug company GSK) sponsored a trial aimed at proving the safety of Avandia.  In 2009 the journal The Lancet published their results, called the RECORD trial.  The researchers determined from their study that Avandia did increase the risk of having a bone fracture and some heart failure, but they did not find that Avandia caused more deaths from a heart attack.  However, the research trial was highly criticized because of certain limitations that were believed to have influenced the final results.

After hearing from an advisory committee on the safety of Avandia, the FDA (which monitors the safety and effectiveness of all medications in the US) ordered for a research trial to take place.  It was called the TIDE trial.  It would also be studying whether or not Avandia caused an increased risk of death from a heart attack.  Three years into the study, in 2010, the FDA put a hold on the trial and no longer allowed researchers to sign up any more study patients.  The FDA had determined that the risks appeared to be too great compared to the possible benefits of lowered blood sugar, so they wanted to restrict the use of Avandia to prevent further possible deaths, at least until they could have a more thorough review of the RECORD trial.

Because of these risks, the FDA decided in September of 2010 that Avandia would no longer be available for use in all patients.  After that decision, Avandia was removed from all pharmacies and can now only be dispensed by mail order pharmacies that are registered under a specific program.  Patients that were taking Avandia prior to September of 2010 could remain on the medication, as long as it was benefitting them and they and their doctor were aware of the heart risks.  Only patients that are unable to control their diabetes with other medications, including Actos, will be allowed to start on Avandia now, and the doctor will have to provide documentation of this.  The patient must also acknowledge that they are aware of the risks of heart attack involved with taking Avandia.

Who should not take Avandia: Any patient starting on Avandia must be completely aware of the risks involved, including the possible increased risk of a heart attack and death.  Patients with certain stages of heart failure should absolutely not take Avandia, and if you have any history of heart problems you need to make your doctor aware of these so that they can fully evaluate if Avandia is right for you.

Drug interactions:  Avandia does interact with certain medications including the cholesterol medications fenofibrate and gemfibrozil, thyroid medications, and the heart medication amiodarone.  Over-the-counter medications glucosamine, licorice, and ginseng also interact with Avandia.  I have not included all medications in this list, only some of the most commonly used, so always talk to your local doctor or pharmacist regarding any medication interactions.

Monitoring: As always, you will have to monitor your blood sugars daily and your doctor will watch your A1c.  If you are taking Avandia, you need to watch for signs of heart failure.  If you start to have swelling (fluid buildup), trouble breathing, or sudden weight gain, contact your doctor immediately.  You should also be watching for nausea and vomiting, decreased appetite, stomach pain, excessive tiredness, and any yellowing of the skin or the whites of your eyes.

Place in therapy for diabetes: As you can see, Avandia is not a very popular diabetes medication anymore.  Right now it is considered one of the last choices for patients, only when nothing else has worked.  But if you are one of the patients taking Avandia for one reason or another, you need to be aware of these risks.

If you want to read more about Avandia, you can visit the drug’s website here.

For more information on what the FDA has to say about Avandia, visit their website here.

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As a disclaimer, I am your “virtual” pharmacist, here to provide you with information and answers to questions.  However, I am not your local pharmacist and could, in no way, be aware of your specific medical needs.  Remember to always check with your medical provider and pharmacist before stopping or starting any new medications.  My posts are based on general pharmacy principles and should not be regarded as your “first opinion” when it comes to your health.  Please consult with your doctor and pharmacist about anything regarding your health.

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