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Part 1: “IT’S A NIGHTMARE” After the Avandia debacle, is history about to repeat itself? Amy Lynn Evans remembers the onset of the illness that left her with seven hundred thousand dollars in medical bills. The morning began like any other. “My son was getting ready for work, and he said to me ‘Mom, you don’t look too well.’ When I went to the emergency room, they found a blood clot on my lung.

The controversial diabetes drug Avandia should stay on the market for now, with relaxed restrictions on its use, Food and Drug Administration advisers said on Thursday.The FDA has been reconsidering its approval of Avandia, which was the world’s No. 1 diabetes drug until research showed it could raise the risk of heart attacks and other heart dangers. Since then, its use has been heavily restricted and prescriptions have plummeted, and the FDA wanted to know if it was worth even keeping the drug on the market.The agency’s expert panel of advisers said the data is clearly confusing and they were...

WASHINGTON -- GlaxoSmithKline LLC will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement in U.S. history, the Justice Department said Monday. Accompanying the criminal case was a civil settlement in which the government said the company's improper marketing included providing doctors with expensive resort vacations, European hunting trips, high-paid speaking tours and even tickets to a Madonna concert. The $3 billion combined criminal-civil fine will be the largest penalty ever paid by a drug company, Deputy...

A widely-used diabetes drug should be pulled from the market, European regulators say.Avandia is used to control blood sugar levels in type 2 diabetes patients. It was licensed 10 years ago and more than 100,000 patients in the UK use it despite on-going concerns linking it to heart problems. After reviewing safety data, the European Medicines Agency said the benefits no longer outweighed the risks and it should be suspended. The drug - generic name rosiglitazone - is also used in combination with other drugs under the names Avandamet and Avaglim.

The Associated Press WASHINGTON -- Federal health scientists have panned a GlaxoSmithKline study that the company used to defend the safety of its embattled diabetes drug Avandia, a once blockbuster-seller that has fallen out of favor because of potential ties to heart attacks. The Food and Drug Administration posted an exhaustive 700-page review of Avandia on Friday ahead of a meeting next week to decide whether the drug should stay on the market. The FDA finds itself in a difficult position that's all too familiar: reviewing a drug approved a decade ago that now appears tied to deadly side effects....

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009....

A molecular pathway could explain how a class of drugs leads to heart failure. Researchers who study how tumours balloon in size have discovered one way that enlargement of the heart can lead to heart failure. The work, although mostly done in mice, could help explain why a class of diabetes drugs called thiazolidinediones (TZDs) increase the risk of heart failure.These drugs have been controversial since a 2007 analysis1 of Avandia (rosiglitazone), a TZD made by GlaxoSmithKline, suggested that patients taking it are at increased risk of heart attack. Less controversial are data linking TZDs with heart failure, a distinct...

NEW YORK — Treatment with a thiazolidinedione, either pioglitazone or rosiglitazone, has been linked to an increased rate of bone fractures, particularly in women, in several recently published reports. Although a definitive link between these drugs and an increased fracture risk has not yet been proved, the evidence amassed so far is suggestive enough to prompt caution in the treatment of patients with a thiazolidinedione (TZD), Dr. Robert G. Josse said at a meeting sponsored by the American Diabetes Association. “In those with a higher fracture risk, consider other hypoglycemic therapy,” advised Dr. Josse, professor of medicine and nutritional sciences...

Contact: Jessica Guenzel jguenzel@wfubmc.edu 336-716-3487 Wake Forest University Baptist Medical Center WINSTON-SALEM, N.C. –A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members. "We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market," write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences. Rosiglitazone and pioglitazone are the two major thiazolidinediones....

Two more studies published in yet another prominent medical journal have raised questions about the safety of Avandia, a once-popular diabetes medicine. One study found that Avandia, made by GlaxoSmithKline, doubled the risks of heart failure and raised the risks of heart attack by 42 percent. A second study found that Actos, a similar drug made by Takeda, actually lowered the risks of heart attacks, strokes and death but, like Avandia, also raised risks of heart failure. Taken together, some of the authors said, the two studies in The Journal of the American Medical Association confirm what doctors and patients...

GAITHERSBURG, Md., July 30 — A federal drug advisory committee voted overwhelmingly on Monday to recommend that the diabetes drug Avandia remain on the market, even after finding that it raised the risks of heart attacks. Panel members said that studies concerning Avandia were too murky to merit drastic regulatory action and that other diabetes medicines might have similar risks... The votes — 20 to 3 on the heart attack risk and 22 to 1 on the marketing — were cast after an extraordinary meeting in which officials from the Food and Drug Administration, which brought the committee together, openly...

Back in the ’60s, when University of Michigan students were holding protests over civil rights and the Vietnam War, an undergraduate named Steven E. Nissen was at the center of the political dissent. Four decades later, that former campus activist is now Dr. Nissen, who is shaking up the nation’s pharmaceutical industry. His questioning of the safety of the Avandia diabetes medication in late May, for example, prompted a federal safety alert and led to a sales decline of about 30 percent for the drug, which brought in $3.2 billion for GlaxoSmithKline last year. Now, with a federal panel soon...

A large clinical study meant to test the heart safety of the diabetes treatment Avandia may be in jeopardy as a result of recent reports of the drug’s risks, according to an executive at its maker, GlaxoSmithKline. Dr. Ronald L. Krall, the medical director for GlaxoSmithKline, said in a telephone interview yesterday that some of the 4,450 patients enrolled in the drug trial, called Record, have dropped out this week because of safety concerns about Avandia. Dr. Krall said he did not yet know how many patients have withdrawn, but said Glaxo was now worried about whether it could complete...

The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert Monday. The 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 (GSK) of London. More than 6 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 percent higher risk of heart attack,...

Diabetes Drug's Benefits Come at a Price By The Associated Press From Associated Press December 04, 2006 1:10 PM EST A newer drug appeared to delay the progression of the most common form of diabetes a little longer than two older medications but also raised the risk of heart problems, weight gain and fractures, a large study has found. The results, along with the higher cost of the new drug, suggest that metformin, sold as Glucophage and other brands, should remain the first choice for newly diagnosed patients with Type 2 diabetes, several specialists said. Avandia, by GlaxoSmithKline PLC, did...

ASSOCIATED PRESS The largest diabetes prevention study ever done has found that a drug already used to treat the disease also can help keep "pre-diabetics" from developing it. But many experts say losing weight and exercising remain a safer, cheaper approach. The drug, rosiglitazone, or Avandia, appeared to cut the risk of developing Type 2 diabetes by more than half, doctors reported Friday. Type 2 is the most common form of diabetes, afflicting more than 200 million people worldwide. Avandia also helped restore normal blood-sugar function in many of those who took it. A second part of the study found...