FDA has declared that the organization will restrict the use of the Diabetes drug Avandia (rosiglitazone) to patients with Type 2 Diabetes who were unable to achieve glucose control on other medications since the drug elevated risk of cardiovascular events, such as heart attack and stroke. The administration further announced that current users of Avandia, who are benefiting from the drug, can continue using the medication if they choose to do so.
Avandia, manufactured by GlaxoSmithKline (GSK), is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 Diabetes Mellitus. The drug is in a class of drugs known as thiazolidinediones, or TZDs.
The U.S. Food and Drug Administration ordered GSK to develop a restricted access program for Avandia under a risk evaluation and mitigation strategy (REMS). Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class.
In addition, the FDA ordered GSK to convene an independent group of scientists to review key aspects of the company's clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs.
The agency has also stopped the GSK's clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs.
The FDA may take additional actions after the independent re-analysis of RECORD is completed.
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