News from the FDA

Today the medication Avandia was in the news.  I talked about Avandia in its own post earlier on the blog (you can read about it here).  When I discussed Avandia, I mentioned the rocky history that it has had in recent years.  Avandia has gone from being the most prescribed diabetes medication to one that is very restricted and rarely used due to possible side effects.  The FDA is meeting this week to reassess whether or not Avandia needs these restrictions, or if it is indeed a safe medication.

So, why all the concern?  Let me provide a review of what I discussed previously about the RECORD trial: “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.”

Because of this trial, and another called the TIDE trial, the FDA decided to restrict the use of Avandia to only certain patients and pharmacies, after extensive paperwork is filed.  In order for Avandia to remain available in the US, the makers of Avandia (GSK) had to agree to a re-adjudication of the RECORD trial by an independent party.  The results of this process are being discussed this week by the FDA, and they will make a decision in the next few days as to whether or not Avandia will continue to be sold in the US.

The studies and processes that the FDA is going through are quite confusing, but the bottom line is that Avandia is being reconsidered as a possible safe alternative for patients with type 2 diabetes; the future of Avandia hangs in the balance as we speak.  As you can see, the FDA is constantly on the lookout for not just things that can help us, but things that can harm us.  I know that I am anxious to see what they decide for the future of Avandia.

If you would like to read more about the committee meetings of the FDA on Avandia, you can look here.

The New York Times also published an article discussing the matter, if you’d like to read it here.

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 considered as your “first opinion” when it comes to your health.  Please consult with your doctor and pharmacist about anything regarding your health.

Posted in Meds and More!

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