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September 23rd, 2010
11:34 AM ET
Diabetes drug Avandia restricted by FDAThe controversial diabetes drug Avandia will stay on the market, but the U.S. Food and Drug Administration restricted its use to patients with type 2 diabetes who cannot control their illness with other medications. The restrictions are based on studies showing an increased risk of serious heart problems, including heart attacks and strokes, in patients taking Avandia, the FDA said Thursday. Just minutes after the FDA posted its decision on its website, its European counterpart, the European Medicines Agency, announced that it’s going further and suspending approval for the marketing of Avandia in Europe. If the decision is finalized by the European Commission, the drug will be removed from the European market, along with two medications Avandamet and Avandaryl that combine Avandia’s active ingredient with other drugs. Dr. Hans-Georg Eichler, the agency’s senior medical officer, said he expects a final decision within “a few weeks.” The FDA’s move runs counter to the recommendation of a senior scientist, Dr. Gerald Dal Pan, who advised the agency to pull Avandia from the market altogether. Dal Pan heads the FDA’s Office of Surveillance and Epidemiology, which oversees the safety of drugs that have previously been approved. In explaining her decision, FDA Commissioner Margaret Hamburg said the agency “is taking this action today to protect patients, after a careful effort to weigh benefits and risks. We are seeking to strike the right balance to support clinical care.” Approximately 600,000 Americans take Avandia, and those patients may continue taking the drug, Hamburg said, “if they are benefitting and they acknowledge that they understand the risks. Doctors will have to attest to patients’ eligibility.” Avandia is used to control blood sugar in type 2 diabetics. It was approved by the FDA in 1999 and by 2006 was widely prescribed, with sales of more than $3 billion in 2006. But the drug came under close scrutiny in 2007, when Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, published an analysis which showed a 43 percent increase in heart attacks for patients on Avandia. The finding led the FDA to order GlaxoSmithKline (GSK), the drug’s maker, to conduct a thorough study of its safety. The full results of that study – known as RECORD – were made public last year. While GSK said the safety data was reassuring, the study came in for blistering criticism at a July meeting of an FDA advisory committee, where Dr. Thomas Marciniak, an FDA scientist who reviewed the data, said GSK ignored several cases of patients who suffered severe adverse effects. In June, another FDA scientist, Dr. David Graham, published an analysis which came to similar conclusions as Nissen had. The accumulation of negative findings led the advisory panel to recommend a clampdown on use of Avandia, although the panel’s vote was split, with 17 in favor of restrictions, while 12 members voted to pull it from the market entirely and three said no action was needed. On Thursday, the FDA ordered GSK to develop a program to ensure that access to Avandia is tightly controlled. It also ordered the company to pay for an independent review of the RECORD study, and ordered a stop to another study comparing Avandia with Actos, a competitor’s drug. Nissen, the Cleveland cardiologist who became the drug’s most well-known critic, sounded a mixed note after hearing of the decisions. “It’s taken too long to stop the use of a drug that clearly was harming people. We’ve got to fix this system.” At the same time, he said he’s satisfied with the FDA and European moves. “The use of Avandia and related products will essentially cease in the U.S. and Europe. I will anticipate that 99 percent of the use of this drug will cease worldwide.” Others who have studied Avandia were more critical. Dr. John Santa of Consumer Reports Health called the FDA’s failure to withdraw the drug, disappointing. “It’s frustrating for us to see there are still several hundred thousand patients on this,” Santa said. “We have concerns that many of those people don’t realize there are other alternatives that are more effective and less risky.” Paul Thacker, who as an investigator for Senator Charles Grassley (R-Iowa) and the Senate Finance Committee accused GSK of burying negative information about Avandia, said the FDA is being too timid. “When you look at all the evidence provided by Congress to the FDA about misconduct by GSK, and when you look at the numerous independent studies saying that the drug is harming patients, what evidence does the FDA want to have to make a decision that a drug needs to be yanked? What evidence do you need?” Thacker left Grassley’s staff this month for a position with the Project on Government Oversight. FDA Commissioner Hamburg and Dr. Eichler of the European Medicines Agency each downplayed their split, saying the two agencies agreed on Avandia’s risks but chose different strategies to manage it. “We discussed the decisions with each other. These decisions were not made in isolation,” Hamburg said. A slight note of discord came from Dr. Janet Woodcock, who heads the FDA division that evaluates medicines, who said “There is still considerable uncertainty of the magnitude and existence of this cardiovascular risk.” In a memo, Woodcock said that patients might still benefit from Avandia if they did not respond to other medications. Medical groups warned that patients should not stop taking Avandia without first talking to their doctors. A joint statement from the Diabetes Society, the American Association of Clinical Endocrinologists and the Endocrine Society said stopping medication “can result in higher levels of blood glucose that may cause serious short term health problems and could increase the risk of long term diabetes-related complications.” In a statement, GSK said it still has faith in its product. Wrote Chief Medical Officer Dr. Ellen Strahlman, “The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions. Type 2 diabetes is a condition that affects the way the human body metabolizes sugar. Symptoms include weight loss, fatigue, blurred vision, frequent urination, and increased hunger and thirst. There is no cure, but patients can manage their conditions with proper diet and exercise; medications or insulin therapy may also be needed, says the Mayo Clinic. About 8 percent of the U.S. population - or nearly 24 million people - is living with diabetes, and 90 percent of those cases are type 2, according to the National Diabetes Information Clearinghouse. Here are alternatives for people with diabetes if you are concerned about Avandia. |
  About this blog
Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.
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But the country still has one of the highest mortality rates in any hemisphere
Swedish officials praised the achievements the country's lockdown free coronavirus strategy on Tuesday, Saying the relaxed policies had helped slow the indication of COVID 19.
"tranny is slowing down, treating COVID 19 patients in intensive care is decreasing significantly, And the increasing death toll curve has been flattened, Swedish new Minister Ann Linde said at a press briefing.
But the wider picture of the country's coronavirus response is a bit more complex.
Some Swedish experts have said the country's methods will eventually yield positive results, handy folks have acknowledged serious pitfalls in the risky strategy.
Visit 's web site for more stories.
Swedish officials defended the country's lockdown free coronavirus strategy on Tuesday, Saying it had managed to slow multiplication of COVID 19.
Sweden never issued a formal lockdown in respond to the coronavirus pandemic. instead, The country's coronavirus model relies on personal burden and encourages citizens to stay home when they're sick and maintain social distancing when in public. Most company, dining places, taverns, And schools have continued open, Though gatherings of greater than 50 people were banned in late March.
At a press briefing in Stockholm on tues, Foreign Minister Ann Linde touted the successes of the nation's policies.
"transmitting is slowing down, the treatment of COVID 19 patients in intensive care is decreasing significantly, And the increasing death toll curve has been flattened, She being said, depending on. "there's full lockdown of Sweden, But many parts of the Swedish society have shut down,
But the wider picture of the country's coronavirus response is a bit harder.
As of the following thursday, Sweden had recorded above what 34,440 bags and 4,125 deaths. the nation's unemployment rate stands at 7.9% and is expected to keep to rise.
And figures from our universe In Data, An online research publication based at the University of Oxford, required that Sweden recorded the most coronavirus deaths in Europe per capita over the seven days from May 12 to May 19.
He predicted that Sweden's case count and death toll would continue to rise in the coming weeks but said the particular was "On the incline,
"When lands with a lockdown open up, intending to get their cases, he was quoted saying.
Other Swedish officials have referred to serious shortfalls in the risky strategy.
on the inside April, just above 2,000 Swedish scientists signed open slavic women dating letters urging the to reconsider a lockdown.
Sweden's former state epidemiologist Annika Linde told the local newspaper Dagens Nyheter on Tuesday that the country's coronavirus response "Maybe has not been the smartest in every respect,
"If we had carry out over again, I think we should have imposed significantly tougher restrictions right from the start, She told the place. "We should have known how underprepared we were in healthcare, And older care. A shutdown could have given us enable you to prepare ourselves, Think things through the use of, And radically slow the spread of infection,
Sweden's foreign minister credited criticism of Sweden's policies in her Tuesday briefing and encouraged experts to continue to voice their opinions.
"we have freedom of speech in Sweden, She being said.
even now, She remained confident that Sweden's actions would cultivate success in curbing the virus finally.
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