Avandia (brand name for rosiglitazone) is an oral pharmaceutical drug that is manufactured and marketed by GlaxoSmithKline. It is used to treat Type-2 Diabetes as it helps to control blood sugar levels. According to WebMD, Avandia should only be used by and prescribed for people who have attempted to control their blood sugar levels with other types of anti-diabetic medications without success.
Avandia consists solely of rosiglitazone which is linked to an increased risk of heart attack, cardiovascular disease, and congestive heart failure. Other medications that include rosiglitazone include the brand names Avandamet and Avandaryl. According to Dr. David Graham, an FDA scientist, over 100,000 strokes and heart attacks may have occurred due to the use of Avandia.
On September 23, 2010, the U.S. Food and Drug Administration (FDA) announced that Avandia was added to the list of medications that require physicians to provide and review a medication guide with patients upon prescribing. This was part of the FDAs initial Risk Evaluation and Mitigation Strategy (REMS). On May 23rd, 2011, their strategy was updated to include further restrictions. It states that Avandia and other medications containing rosiglitazone will no longer be available from retail pharmacies. In order to prescribe and obtain the medication, patients and their healthcare providers will need to be enrolled in a special program.
As part of the largest health care fraud settlement in U.S. history, GlaxoSmithKline agreed to pay over $657 million for misrepresentations in their marketing of Avandia. They also agreed to pay a criminal fine of over $242 million for failing to include certain safety information about the drug in reports to the FDA.
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