FDA’s tougher guidelines on diabetic drugs to avoid potential cardiac risks

In response to the increasing heart attack risks, the FDA has revised its guidelines for diabetes drug. The agency has called for more scrutiny on heart condition risks.

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Study finds leading diabetes drug can lead to heart disease

Harvard University researchers have found the diabetes drug Avandia can be harmful to heart and can lead to death. The study was led by Dr. Wolfgang Winkelmayer of Brigham and Women’s Hospital in Boston. He and his colleagues reported people aged 65 and older who took Avandia (rosiglitazone) had a 15 percent higher rate of death after an average of one year.

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Public Citizen requests FDA to ban diabetes drug Avandia

Diabetes drug Avandia, has been associated with various diseases like heart attacks, heart failure, bone fractures, anemia and retinal edema with vision loss. As a result, the non-profit body called Public Citizen has filed a petition to the FDA to ban the drug. Avandia Plaintiffs Steering Committee has confirmed it.

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No Liver Safety Issue With AVANDIA

In an response to the petition filed by Public Citizen on AVANDIA, to the Food and Drug Administration, GlaxoSmithKline has issued the following response.

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Diabetes drug not always harmful on heart

Finally a good news for all the diabetes patients. A research in the Johns Hopkins Bloomberg School of Public Health failed to produce reliable conclusions about the effects of oral diabetes medicines on cardiovascular health, despite controversy over the drug Avandia.

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Diabetes drug found linked with heart failure and death

Thousands of diabetics taking Avandia and Avandamet are told to go the doctor fro check up. Thousands of Australians are advised to go to doctor after major changes were made to the drugs’ guidelines for use.The changes, ordered by the Therapeutic Goods Administration (TGA), come after two major studies released last year showed the products doubled the risk of heart failure and death in some people.

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FDA To Go For More Test For Diabetes Drug To Avoid Heart Problems

At the two day meeting on the standard of diabetes drug, the FDA officials have decided that the testing standard on the type 2 diabetes drug should more thorough to avoid the risk of heart problems. The panel of outside experts voted 14-to-2, at the end of a two-day meeting, to recommend that all makers of these drugs conduct long-term cardiovascular trials, even if the drugs show no signs of heart problems in initial trials.

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FDA To Discuss The Diabetes Drug Standard In Two Day Meeting

A prominent medical expert, Cardiologist Steven Nissen of the Cleveland Clinic urged the U.S. Food and Drug Administration to raise its standards for approving diabetes drugs on Tuesday. Nissen said that companies need to prove new drugs don’t increase cardiovascular disease, the leading killer of diabetics. Nissen suggested that, in addition to requiring more pre-approval studies, companies should have large, long-term studies in place when a drug is approved to monitor whether the drug increases the risk of cardiovascular disease. He discussed the issue of diabetes drugs standards as a part of a two-day meeting starting Tuesday.

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FDA To Reconsider The Diabetes Drug Standard For Safety And Effectiveness

The Food And Drug Administration officials are likely to have a meeting to discuss the proper regulations for the diabetes medicines. They are likely to make the rules and regulations tougher. They reconsider the Government regulations after they were criticized last year for their handling of heart risks connected with a widely used GlaxoSmithKline pill. During the two day meeting the FDA has decided to discuss the issue with diabetes experts, cardiologists and statisticians. If FDA adopts such a standard, companies like GlaxoSmithKline, Merck & Co. Inc. and Takeda Pharmaceuticals could be forced to conduct expensive, multi-year studies previously not required of diabetes medicines.

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