FDA posts heart attack warning on anti-diabetes drug Avandia

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Washington: The US Food and Drug Administration has announced that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

Janet Woodcock, MD, the FDA’s deputy commissioner for scientific and medical programmes and acting director of the Center for Drug Evaluation and Research said: “The FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings.

“The FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines.”

Avandia is manufactured by Philadelphia-based GlaxoSmithKline (GSK) and was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn’t enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia’s existing boxed warning – FDA’s strongest form of warning – includes the following statement:

“A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.

GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

So far no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

Stem cell hope for diabetes

New Orleans: Scientists have used stem cells from human bone marrow to repair defective insulin-producing pancreatic cells responsible for diabetes in mice.

The treatment also halted damage to the kidneys caused by the condition.

Researchers from New Orleans’ Tulane University are hopeful it can be adapted to treat diabetes in humans.

Stem cells are immature cells which have the capacity to turn into any kind of tissue in the body.

The US team treated diabetic mice who had high blood sugar and damaged kidneys.

One group of mice were injected with stem cells. After three weeks they were shown to be producing higher levels of mouse insulin than untreated mice and had lower blood sugar levels.

The injections also appeared to halt damaging changes taking place in the glomeruli, the bulb-like structures in the kidneys that filter the blood.

Researcher Dr Darwin Prockop said: “We are not certain whether the kidneys improved because the blood sugar was lower or because the human cells were helping to repair the kidneys.

“But we suspect the human cells were repairing the kidneys in much the same way they were repairing the insulin-producing cells in the pancreas.”

Dr Prockop said his team were planning to carry out trials in patients with diabetes.

“The physicians will be selecting patients with diabetes whose kidneys are beginning to fail.

“They will determine whether giving the patients large numbers of their own adult stem cells will lower blood sugar, increase secretion of insulin from the pancreas and improve the function of the kidney.”

Theoretically, pancreatic beta cells produced from a patient’s own bone marrow could be used to treat diabetes, overcoming the requirement for immunosuppression following islet transplantation.

However, a way to prevent transplanted cells from being destroyed by the body is needed as this is why Type 1 diabetes develops in the first place.