Scientists link diabetes drugs to heart failure

[Cheba_Mami]

FDA: No apparent heart risk from Prilosec, Nexium - CNN.com

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hmmm what can i say? it wouldn't surprise me if still there's something wrong

[Al-khiyal]

August 15, 2007 -- Diabetes drugs Avandia and Actos will be labelled with severe warnings about a risk of heart failure to some patients, U.S. health officials said Tuesday.

The makers of the drugs, GlaxoSmithKline Plc and Takeda Pharmaceutical Company Ltd., have agreed to add the "black-box" warnings, the Food and Drug Administration said. The warnings, the most severe that prescription drugs can bear, stress the medicines may cause or worsen heart failure and that patients should be closely monitored.

The warnings also apply to combination drugs that include the active ingredients in Avandia, made by Glaxo, or Takeda's Actos. The drugs help patients with Type 2 diabetes control their blood sugar levels.

The warnings, which the FDA said in June it would seek, are separate from concerns that Avandia also raises the risk of heart attack.

FDA advisers said last month that the heart attack risk in patients taking Avandia appeared real, but the evidence wasn't conclusive enough to merit pulling the drug from the market.

They did recommend Avandia's label be updated to include information on that risk. The FDA said it was continuing its review of the issue.

A Health Canada spokesman said Tuesday that a review of the class of drug known as rosiglitazone (Avandia) is underway and revised warnings are being considered.

"Health Canada's review of the safety data on rosiglitazone is ongoing, and is expected to be completed by late fall 2007," Alastair Sinclair, media relations officer for Health Canada, said Tuesday in an e-mail.

"Further revisions to the product monographs are under consideration. New information will be made public to Canadians and Canadian health-care professionals as soon as it is available."

2 diabetes drugs require label with heart failure warnings: FDA

[Al-khiyal]

Diabetes drug Avandia suspended over health fears

September 23, 2010 -- Around 90,000 British diabetes patients were warned against continuing to use one of the most popular treatments for their condition after regulators ruled it could lead to heart attacks or strokes. After a three-year battle with UK pharmaceutical giant GlaxoSmithKline, the European Medicines Agency (EMA) recommended that Avandia, or rosiglitazone, which is used by 2 million people worldwide, should no longer be used after growing concerns about its potentially damaging effects on patients. The benefits of the drug, which is used to control Type 2 diabetes, no longer outweighed its risks, the regulator ruled. The decision means that no new prescriptions can be issued for it, and that no new patients can start receiving a drug once seen as a major breakthrough in tackling the disabling effects of diabetes.

Evidence linking Avandia to an increased risk of a heart attack or stroke has been building since 2007. GlaxoSmithKline has insisted that Avandia is safe but in July agreed to pay $460 million (£304 million) in damages to settle about 10,000 lawsuits in America linking its use to patients suffering serious medical setbacks.

"Avandia is going to be suspended throughout Europe from now – that is, it can't be prescribed," said a spokeswoman for the Medicines and Healthcare products Regulatory Agency (MHRA), the UK's drug safety watchdog, last night. "For those who are on it, healthcare professionals should review their treatment and switch them to another drug or drugs if necessary." Professor Kent Woods, the agency's chief executive, said: "Patient safety is the top priority for the MHRA. Clinicians should review all patients currently on rosiglitazone and take appropriate action."

"The EMA no longer believe that Avandia is a safe treatment," said Simon O'Neill of the charity Diabetes UK. "We are recommending that people with diabetes taking Avandia get in touch with their healthcare team as a matter of urgency to discuss their treatment options. We would not advise them to stop taking their medication in the meantime even if they are experiencing adverse side effects, as it is very important that people with diabetes keep their blood glucose under control to prevent short- and long-term complications."

First used in 1999, Avandia works by controlling blood sugar levels through making patients more sensitive to their own insulin. But the MHRA pointed out that action was needed because diabetics already have an increased risk of having a heart attack or stroke.