Avandia Restrictions Put in Place in U.S.

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By: Staff Writers | Published: May 20th, 2011

Avandia will no longer be found on most U.S. pharmacy shelves after November, as part of a risk evaluation and mitigation strategy (REMS) designed to reduce patients’ exposure to the risk of heart problems from Avandia

The FDA announced the new Avandia restrictions on May 18, indicating that the medication will only be available from select pharmacies by mail order and special educational programs will be required before the drug can be prescribed.

The new restrictions on Avandia, which also apply to Avandamet and Avandaryl, were put in place after the FDA decided not to issue a recall for the diabetes drug, despite a known increased risk of heart attacks.

Use of Avandia will be restricted to individuals already being successfully treated with the drug, whose blood sugar can not be controlled with any other anti-diabetic medications. In addition, it is necessary that patients consult with their healthcare provider and indicate that they do not want to use Actos or another pioglitazone medication, such as Actosplus Met, Actosplus Met XR or Duetact.

Avandia (rosiglitazone) was first introduced in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics throughout the world, but sales began to plummet in mid-2007, after potential Avandia heart risks were highlighted in a study published by the New England Journal of Medicine.

A “black box” warning was added to Avandia in the United States in November 2007, but many critics continued to argue that the warning was not strong enough and called for an Avandia recall to be issued in the United States.

Despite heated internal debate, the FDA decided in September 2010 not to recall Avandia in the United States, allowing the medication to remain on the market with severe restrictions on who can use the product.

GlaxoSmithKline has faced thousands of Avandia lawsuits in the U.S. filed by people who allege that the drug maker failed to adequately warn about the risk of heart problems from Avandia. A number of Avandia settlements have reportedly been reached by GlaxoSmithKline in an effort to resolve the litigation, but thousands of cases are still pending in courts throughout the country.

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There Are 3 Comments So Far • (Add Your Comments)

  1. People need to understand that every drug has side effects. A decision to prescribe and take a drug is a cost/benefit decision where the costs are not just economic but physical as well. Drugs are not as targetted as people assume; they have broad effects so that the effect you desire may not outweigh the disadvantages of the drug effects one does not desire.
    That’s why prevention is always the best strategy, albeit one that doesn’t always work either. Treatment almost always involves a compromise. It’s up to the doctor and patient to weigh the choices wisely.

  2. As a 100% disabled veteran who was given Avandia and had major illnesses associated with Avandia, strokes etc. once I notified GSK the maker of Avandia and then was informed by the VA to cease Avandia all because an internal investigation showed GSK KNEW THE DRUG WAS A DANGEROUS AND OFTEN FATAL to people taking it, GSK kept selling it to the VA because they knew it would take years to uncover the dangers. I have spoken to staff in R & D at GSK and several senior Executives all who knew this, now Pepper Hamilton there outside Lawyers are delaying settlements and covering up this in order to bill millions to GSK to delay. All waiting to see how many people will die thus they won.t have to settle. It seems that GSK and there Lawyers are indeed engaged in a conspiracy to hurt Americans who have taken this deadly drug.

  3. If GSK had been forthcoming and honest about the potential health risks associated with taking Avandia, they would not have found themselves in the lawsuits they’re currently defending. However, because they lied and then tried to cover up the truth, well,,,,, you know what happened. The best advice GSK could receive is to admit the mistake, settle the claims and put this thing behind them! However, I believe their lawyers will try to drag this thing out in an effort to avoid paying out larger claims! One must remember that the drug was higly successful for some folks with diabetes. Let them sign a waiver, continue to take the drug and use the revenue to offset the loss.

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