Content about Avandia

November 25, 2013

Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

SILVER SPRINGS, Md. – Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

June 7, 2013

A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

PHILADELPHIA — A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

May 19, 2011

A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

SILVER SPRING, Md. — A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

April 12, 2011

A point-of-sale safety check may reduce the risk of patients unsafely receiving a drug for Type 2 diabetes that may increase their risk of heart attack, according to a new study conducted by pharmacy benefit manager Prime Therapeutics and scheduled for presentation at the 23rd annual meeting of the Academy of Managed Care Pharmacy in Minneapolis.

ST. PAUL, Minn. — A point-of-sale safety check may reduce the risk of patients unsafely receiving a drug for Type 2 diabetes that may increase their risk of heart attack, according to a new study conducted by pharmacy benefit manager Prime Therapeutics and scheduled for presentation at the 23rd annual meeting of the Academy of Managed Care Pharmacy in Minneapolis.

March 18, 2011

With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

LONDON — With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

February 14, 2011

GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.

The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.

January 17, 2011

Drug maker GlaxoSmithKline will take a legal charge of $3.4 billion related to its promotion of a controversial diabetes drug.

LONDON — Drug maker GlaxoSmithKline will take a legal charge of $3.4 billion related to its promotion of a controversial diabetes drug.

The British company said the charge related to an investigation by the U.S. Attorney’s Office for the District of Colorado regarding sales and promotion of the drug Avandia (rosiglitazone) in spite of reports of the risk of heart attacks in patients taking it.

November 14, 2010

The world of generic drugs has a big year ahead of it. Actually, it has...

The world of generic drugs has a big year ahead of it. Actually, it has a few big years ahead of it. But 2011 in particular carries a certain symbolic value as the year in which Pfizer, the world’s biggest drug maker, loses control of its patent for the cholesterol-lowering drug Lipitor (atorvastatin calcium), the world’s top-selling drug.

September 22, 2010

The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes...

SILVER SPRING, Md. The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes drug made by GlaxoSmithKline.

The agency said Thursday that it would restrict access to the Type 2 diabetes medication Avandia (rosiglitazone) in response to clinical study data suggesting that its use can increase the risk of heart attacks and strokes.