Article; Suits filed against drug giant over Avandia

The controversy over the drug Avandia continues to build.
Class action law suits were filed in Canada yesterday against Mississauga pharmaceutical giant SmithKlineGlaxo while an American panel of experts declared that the company should have given tougher warnings to diabetes patients outlining the risks the drug posed to the user's heart health.
U.S. government health advisers voted not to ask the U.S. Food and Drug Administration (FDA) to withdraw the drug, but concluded that there is evidence that its use leads to increased risk of a heart attack. It recommended the drug’s warning label be updated and there should be additional study into the matter.
Meanwhile, class action law suits were filed in Ontario and Saskatchewan on behalf of numerous patients who have experienced health complications after taking the diabetes drug.
Lawyer Tony Merchant told Canadian Press that the filings are on behalf of patients who have died after taking the drug or have suffered heart attacks and loss of vision.
“Every drug does some good or bad,” Merchant said. “The question is whether people were sufficiently warned.”
In an email to The News, former Avandia patient Joyce Cormier of London, Ont. said she took the drug when it first hit the market.
“This drug caused my ankles to swell to the point where little blood vessels burst causing permanent damage to my lower legs,” she said. “I am an incomplete paraplegic, and while I can stand and sometimes use a walker, the swelling persisted during the time I was on this medication. I, for one, hope the FDA takes it off the market. I was fortunate that I didn’t have more serious problems.”
Regulatory health agencies “should not fool around with people’s lives,” Cormier added.
Earlier, FDA scientist Dr. David Graham told the joint panel of experts that the drug’s heart risks, combined with its lack of unique short-term benefits in helping diabetics control blood sugar, meant continued sales were not justified.
GlaxoSmithKline has argued that there is no increased risk, citing its own analyses of studies of Avandia, also called rosiglitazone.
“The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents,” said Dr. Ronald Krall, the company’s senior vice president and chief medical officer.
The FDA convened the experts to consider whether Avandia should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA had said information from dozens of studies pointed to an increased risk of heart attack.
The FDA isn’t required to follow the advice of its advisory committees but usually does.
North of the border, Health Canada is doing its own analysis of study findings and has been following the FDA advisory panel presentations live through a weblink.
“New information will be made public to Canadians and Canadian health care professionals as soon as it is available,” said media relations official Alastair Sinclair.

Source:www.mississauganews.com