Would Avandia Heart Attack Risk Keep Drug From Being Approved Under New FDA Guidance
The FDA has announced new guidance for the pharmaceutical industry that applies to all diabetes drugs currently under development. This will require that new medications be put through additional studies designed to provide evidence that they will not increase the risk of heart attacks and other cardiovascular events. However, it is unclear what impact this will have on drugs that are already on the market, like Avandia, whose heart attack side effects have already been established.
>>INFORMATION: Avandia Heart Attack Lawsuit
Avandia (rosiglitazone) was approved by the FDA in 1999 for treatment of type 2 diabetes. The drug increases the body’s sensitivity to insulin and aids in the management of blood sugar levels. However, side effects of Avandia have been associated with an increased risk of heart attacks, congestive heart failure, liver failure, bone fractures, vision loss and death.
Under the new guidance, the FDA is recommending that drug makers conduct “more robust and adequate design and data collection approaches” to make sure that the drugs do not increase the heart risks when compared with older treatments. This will require testing on a greater number of high-risk diabetes, including elderly patients and those with more advanced diabetes and renal impairment. In addition, they will need to have independent cardiologists evaluate any cardiovascular events.
The new guidance only applies to drugs under development which have not already been approved by the FDA. However, in a statement released Wednesday, the drug regulatory agency indicated:
The FDA remains confident that currently marketed antidiabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control. The FDA is continuing to evaluate how today’s recommendations will be applied to already approved antidiabetic drugs and expects to release further guidance on this issue in the future.
There is currently a petition before the FDA calling for an Avandia recall, which was filed in October and it appears very unlikely that Avandia ever would have been approved under the new FDA standards if it was in development today.
Avandia already carries “black box” warnings about potential side effects which increase the risk of congestive heart failure and heart attacks. In addition, the American Diabetes Association has unanimously recommended against the use of Avandia because of concerns about the heart risks and the availability of other safer drugs which can help manage blood sugar levels.
So the question is, how much longer will Avandia be permitted to remain on the market? There are still approximately 10,000 prescriptions for Avandia filled every day, despite the fact that a number of experts have concluded that it is an “unacceptably dangerous drug.”
AVANDIA HEART ATTACK LAWSUITS
The Avandia lawyers at Saiontz & Kirk, P.A. represent individuals who have suffered a heart attack, congestive heart failure, liver failure, macular edema, bone fractures or death as a side effect of Avandia. Lawsuits are being reviewed for individuals throughout the United States, and there are no fees or expenses unless a recovery is obtained.
To review a potential Avandia heart attack case, request a free consultation and claim evaluation.
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