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Posts Tagged ‘Avandia’

The FDA Announced Prescription Drug Avandia Use is Restricted

by admin on: June 20th, 2011

Avandia is the brand name formulation of the prescription drug rosiglitazone. This drug is classified as a thiazolidinedione (abbreviated TZD) and is used in combination with a special diet and exercise program in order to treat type 2 diabetes.

Type 2 diabetes is a condition where a person???s body is not capable of using insulin (a hormone produced in the pancreas that controls blood-sugar levels). Avandia works by increasing a person???s sensitivity to insulin and helps prevent a serious condition known as diabetic ketoacidosis, which occurs if a person???s blood-sugar level remains high and is not treated.

After reviewing the results from long-term trials for Avandia (RECORD and TIDE trials) the U.S. Food and Drug Administration (FDA) made an announcement on September 23, 2010 stating that the use of Avandia (rosiglitazone) will be restricted to patients that have been diagnosed with type 2 diabetes and are unable to use other medications to control their diabetes. The reason for this restriction is that the aforementioned studies produced data that indicated certain people taking Avandia were at an increased risk for suffering a cardiovascular event ??? such as a stroke or a heart attack.

Avandia is manufactured by the pharmaceutical company GlaxoSmithKline (GSK). The FDA instructed GSK that they will need to develop a restricted access program for this drug using a risk evaluation and mitigation strategy (REMS). What this means for patients is that Avandia will only be available to new patients if they do not respond positively to (or are unable to take) Actos (pioglitazone; this drug is also classified as a TZD) or other medications for type 2 diabetes.

In addition, a patient???s physician will have to approve and document their eligibility and ensure that the patient clearly understands the safety concerns (increased potential for a cardiovascular even) before a prescription is provided for Avandia.