Diabetes drugs double women's fracture risk

From USA Today:
Long-term use of a popular class of oral diabetes drugs doubles the risk of bone fractures in women with type 2 diabetes, a new study reports.

According to researchers at Wake Forest University School of Medicine who reviewed 10 previous drug trials, for every 20 women in their 70s with type 2 diabetes who took thiazolidinediones — rosiglitgizone (brand name Avandia) and pioglitazone (brand name Actos) — for at least one year, one of them has a chance of suffering a fracture. In women in their mid-50s, the figure equals one fracture in every 55 women. That's more than double the normal risk for those age groups. ...more

Doctors allege intimidation in raising drug warnings, investigation shows

From CBC News:
Two physicians who tried to warn about the high risk of serious side-effects of the Type 2 diabetes drug Avandia allege they were intimidated by the company that sells it, a CBC investigation revealed Wednesday.

Last year, a review published in the New England Journal of Medicine found a 43 per cent higher risk of heart attack among people taking Avandia, or rosiglitazone, compared to a control group, and 64 per cent more likely to die of cardiovascular problems.

Avandia was hailed as a breakthrough for blood-sugar control. It is designed to help sensitize the body to insulin.

Both the U.S. Food and Drug Administration and Health Canada have issued strong warnings as a result of the 2007 study. By that point, researchers were estimating thousands of people taking Avandia had died, given it had been on the market since 1999. In Canada in 2007, doctors had written more than a million prescriptions for Avandia, according to IMS Health Canada, an industry trend watcher.

In 2000, Dr. Mary Money, an internist from Hagerstown, Md., raised one of the earliest alarms about Avandia. Of 33 patients she put on the new drug, 20 went on to develop serious edema, or fluid retention — a symptom of heart failure. ...more

Ban diabetes drug Avandia: consumer group to FDA

From CBC News:
The diabetes drug Avandia should be banned over its risks of heart and liver damage, a U.S. consumer group urged.

In a petition filed with the U.S. Food and Drug Administration on Thursday, the group Public Citizen called for the Type 2 diabetes drug, whose generic name is rosiglitazone, to be pulled from the market.

Last week, the American Diabetes Association and a European counterpart unanimously advised doctors against using Avandia in updated treatment guidelines.

"The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities," Public Citizen said in its petition.

"Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure."

In November 2007, GlaxoSmithKline Inc., the manufacturer of rosiglitazone, updated its prescribing information in consultation with Health Canada after a study published in the New England Journal of Medicine reported a 43 per cent higher risk of heart attack for those taking rosiglitazone compared to people taking other diabetes drugs or no diabetes medication at all. ...more

N.S. man sues over drug Avandia

From the Halifax Chronicle Herald:
A Nova Scotian man has launched a class action lawsuit against the federal government and the company responsible for the popular drug Avandia, most commonly used to treat Type 2 diabetes.

Counsel for Ronald Finck of Shinimicas Village, Cumberland County, filed the statement of claim in Nova Scotia Supreme Court in Halifax on Wednesday.

Named as defendants are Glaxosmithkline Inc., Glaxosmithkline PLC, Glaxosmithkline Services Unlimited, Smithkline Beecham Corporation and the Attorney General of Canada.

In the court document, lawyer Wei Wu of the Merchant Law Group in Saskatchewan claims that Avandia, also known as rosiglitazone, raises the risk of heart attack, heart failure and death in older patients.

He alleges that Glaxosmithkline knew or should have known that its product, approved by Health Canada on March 21, 2000, was unsafe for patients. ...more

Diabetes drug linked in study to heart risk

From the Toronto Star:
A massive "real world" study of the popular diabetes drug Avandia shows it can produce distressing increases in the risks of heart attacks and death, according to Ontario research published yesterday.

And a key study author says the research, which followed some 160,000 diabetics in this province for more than four years, should cause Health Canada to consider new restrictions on its use.

The drug – prescriptions for which are filled more than a million times a year in this country – can increase the risks of heart failure by 60 per cent and of heart attacks by 40 per cent over other medications meant to control Type 2 diabetes, the study says.

"Our study is the first one done in a real-world population that really supports that these drugs are associated with a higher risk of cardiac events," says lead author Dr. Lorraine Lipscombe.

"We hope that the experts at Health Canada will consider our study ... and make some new decisions about the future of these drugs," says Lipscombe, a researcher with the Institute for Clinical Evaluative Sciences. ...more

Common diabetes drug may increase chances of developing osteoporosis

From CBC News:
The popular diabetes drug marketed as Avandia may increase bone thinning, a discovery that could help explain why diabetics can have an increased risk of fractures.

New research raises the possibility that long-term treatment with rosiglitazone, as Avandia is also called, could lead to osteoporosis. The diabetes drug is used to improve response to insulin.

While bones seem solid, they constantly are being broken down and rebuilt by the body. Researchers found that in mice, the drug increased the activity of the cells that degrade bones, according to a report in this week's online issue of Nature Medicine. ...more

Manufacturer restricts use of diabetes drug Avandia

From CBC News:
The manufacturer of a drug for treating Type 2 diabetes has placed new restrictions on use of the medication based on a Health Canada review of clinical data pointing to an increased risk of heart-related problems in some patients.

GlaxoSmithKline Inc., in consultation with Health Canada, is updating prescribing information on products made from or containing the drug rosiglitazone: Avandia, Avandamet and AvandarylTM.

Once touted as the gold standard for preventing Type 2 diabetes in high-risk patients, rosiglitazone lost its glitter after a study published in the New England Journal of Medicine in May showed Avandia significantly raised the risk of heart attack and possible death. ...more

New restrictions on the use of rosiglitazone products due to cardiac safety concerns (Avandia, Avandamet, Avandaryl)

From Health Canada:

GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important new restrictions on the treatment of type 2 diabetes mellitus with the rosiglitazone-containing products: AVANDIA® (rosiglitazone), AVANDAMET® (rosiglitazone and metformin), and AVANDARYLTM (rosiglitazone and glimepiride).

Further to a Health Canada assessment of adverse event reports, published articles* and other available information on congestive heart failure, myocardial infarction, and related events, the Canadian Product Monographs for rosiglitazone-containing products are being updated and will include the following new usage restrictions: ...more

Class-action suits launched against makers of diabetes drug

From the Toronto Star:
A lawyer is attempting to launch class action lawsuits in two provinces against the makers of Avandia, a popular Type 2 diabetes drug.

Tony Merchant of the Merchant Law Group filed statements of claim in Saskatchewan and Ontario on Monday, alleging GlaxoSmithKline should have done more to warn consumers of the drug's risks.

Merchant says statements of claim will be filed in other provinces later this week.

"(The plaintiffs) have suffered heart attacks or suffered loss of their vision, and in some cases they have died," Merchant alleged in an interview late Monday. ...more

Diabetes drug should remain on market: advisers

From CTV News:
The widely used diabetes drug Avandia should remain on the market, U.S. government health advisers recommended Monday. They say evidence of an increased risk of heart attack from taking GlaxoSmithKline's Canadian-manufactured drug doesn't merit removal.

The nonbinding recommendation to the Food and Drug Administration came on a majority vote by the panel.

"We're being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision," said Rebecca Killion, a Bowie, Md., diabetic and the panel's patient representative. ...more

Two Diabetes Drugs Double Heart Failure Risk: Study

From the Washington Post:

Patients taking either of the diabetes drugs Avandia or Actos face twice the risk of developing heart failure compared to people not on the popular medications, a new study finds.

This means for every 50 patients with type 2 diabetes taking these drugs, one patient will develop heart failure within 26 months, according to the report released Friday and published in the August issue of Diabetes Care.

"Both Avandia and Actos double the risk of heart failure," concluded the lead author of the first study, Dr. Sonal Singh, an assistant professor of internal medicine at Wake Forest University School of Medicine. "We know these drugs increase the risk, but we found the risk is more substantial than suspected. This occurs at even the lowest dose and among young patients." ...more

Experts say early results from Avandia study not reassuring, despite Glaxo's claim

From the Canadian Press:
The maker of the controversial diabetes pill Avandia on Tuesday published preliminary results of a study that the company claims show the drug does not raise heart risks. However, experts say the results are inconclusive and even seem to suggest more risk from the drug.

More people on Avandia suffered heart problems than those on other diabetes drugs - a bad sign even if the difference was so small that it could have occurred by chance alone, some doctors said. ...more

Deaths linked to diabetes drug?

From the Winnipeg Free Press:
Health Canada says the deaths of several Canadians could be linked to the popular Type 2 diabetes drug Avandia, the Free Press has learned.

Last week, a report in the New England Journal of Medicine linked Avandia to a greater chance of heart attack and possibly death.

Initially, Health Canada told the media that 28 Canadians who were taking Avandia suffered heart attacks since 2000. They didn't say if any of the heart attacks were fatal.

But after the Free Press looked into Health Canada's adverse-reaction database, spokeswoman Renee Bergeron confirmed 19 people have died from heart attacks or heart failure while taking Avandia. ...more

Pharmacist urges Avandia users to keep using it

From the Peterborough (Ont.) Examiner:
Avandia — a Type 2 diabetes drug that's been possibly linked to six Canadian deaths — is still "excellent" for diabetics as long as they don't have heart conditions such as congestive heart failure, a pharmacist says.

Murad Younis, of Westmount Pharmacy on Charlotte Street, says he worries all diabetics will be scared off the daily tablets after the U.S. issued a safety alert last week.

The alert was in response to a New England Journal of Medicine (NEJM) study linking the drug to a greater risk of heart attack.

Avandia got more bad press when Health Canada reported Wednesday a preliminary review indicates the drug could be linked to the deaths of six people who died from heart attacks or heart failures. ...more

Cardiac Safety of Avandia® (rosiglitazone maleate)

From Health Canada:
GlaxoSmithKline Inc (GSK), in conjunction with Health Canada, would like to address public concerns about the safety of Avandia®.

An article recently published in the New England Journal of Medicine (NEJM) has raised concern about an increased risk of myocardial infarction (heart attack) and cardiovascular death in patients with type 2 diabetes treated with Avandia®. This article was based on a review of 42 clinical studies. The conclusions reached require confirmation. Further investigation of these results is underway and more information will be communicated when available.
For the public

Diabetes drug linked to heart attacks

From the Toronto Star:
The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, prompting the U.S. government to issue a safety alert yesterday.

The U.S. Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC of London.

More than six million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 per cent higher risk of heart attack, according to the review published by the New England Journal of Medicine. ...more