US FDA restricts access of drug Avandia the diabetes drug , Drug will be made available only after risk evaluation and doctors request to the manufacturer .
FDA halts GSK’s clinical trial named TIDE trials, The TIDE clinical trial compares drug Avandia to drug Actos and to other standard anti diabetes drugs, FDA also asks GSK to review key aspects of clinical trial named RECORD which studied the cardiovascular safety of Avandia compared to standard diabetes drugs.
This week after undertaking a review of diabetes drug Actos (pioglitazone) for its possible association with bladder cancer , US FDA has taken a remarkable step by making access of Avandia (rosiglitazone) restricted.
That means the drug Avandia (rosiglitazone) will be made available to patients only after risk evaluation and through a doctors request. The drug is allowed to stay in market.
The drug Actos (pioglitazone) and Avandia (rosiglitazone) belongs to the same class known as thiazolidinediones (TZDs)
The US FDA said in their press release on 23-09-2010 that , they are significantly restricting the use of drug Avandia (rosiglitazone) in Type 2 diabetes mellitus where patients glucose levels can not be controlled with other available drugs .
They are placing this restrictions because FDA found that the data indicates elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
Avandia is manufactured by GlaxoSmithKline (GSK), Avandia is used with diet and exercise to control and improve glucose (blood sugar) in patients with Type 2 diabetes.
Now US FDA has asked the pharmaceutical manufacturer GSK to develop a Restricted Access Program for Avandia under a Risk Evaluation and Mitigation Strategy( REMS). Under this strategy ( REMS) GSK will make available drug Avandia to new patients only in conditions where patients are not able to achieve glucose control with other medications and are not able to take Actos (pioglitazone), which is the only other drug in this class of thiazolidinediones (TZDs).
FDA has also mentioned in their press release that, the current users of drug Avandia who are benefiting from use of the drug Avandia will be able to continue using the medication.
For use of drug Avandia Doctors are required to attest to and document of their patients' eligibility; also patients are required to review risk factor statements describing the cardiovascular safety concerns associated with this drug and acknowledge that they understand the risks.
FDA has also ordered GSK to form a independent group of scientists to review in detail findings in clinical trial called as RECORD, that investigated the cardiovascular safety of Avandia in comparison with other standard diabetes drugs.
FDA found in their review of the clinical trial RECORD some important questions about potential bias in the identification of cardiovascular events. Hence US FDA has asked GSK to do independent review and provide additional clarity about the findings.
In addition US FDA has taken a remarkable dissension to halt the GSK’s clinical trial known as TIDE rescinding all of the regulatory deadlines for completion of the trial. TIDE clinical trial compares drug Avandia to drug Actos and to other standard anti diabetes drugs.
Rosiglitazone selectively act up on PPARγ receptors in fat tissue where it regulate gene expression for cellular process like fatty acid uptake and storage, and glucose uptake .
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