Avandia

Swiss Scientists Confirm Avandia's Link to Osteoporosis

2008-05-15T00:54:50Z

Swiss researchers recently concluded that Avandia, a type 2 diabetes drug, nearly doubles the chances of osteoporosis and bone fracture among patients who take the drug and is increased for patients taking the drug for more than a year. The results of the study come on heels of controversy surrounding the drug’s link to increased heart disease and various studies warning of potential risks related to bone degradation.

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The type 2 diabetes drug was introduced to the market in 1999 from GlaxoSmithKline, and has been reportedly prescribed to nearly 3.5 million Americans suffering from the disease. Avandia was once considered one of the most popular treatments until results of several clinical trials reported in the news in 2007 determined a strong connection of the drug to cardiomyopathy and cardiovascular disease. One study, published by the Cleveland Clinic, found a 43 percent increase for patients developing these various heart diseases. Dr. John Buse, an expert on diabetes, has openly stated that Avandia may have been responsible for approximately 83,000 preventable myocardial infarctions over the last few years.

Additional studies then began to surface linking the drug to an increased risk of osteoporosis, although many of the studies did not have definitive proof of the connection until the recent Swiss study was published. The Swiss study determined patients on Avandia and Actos, which is also part of the Avandia class of drugs known as thiazolidinediones, doubled and, in some cases, tripled the “odds of non-spine fractures” among patients, according to news reports. For patients who took the drug for 12 to 18 months, this risk increased, and for those on the drug longer than two years were found to be at the highest risk of bone fracture and osteoporosis.

Osteoporosis is a disease characterized by loss of bone density and leads to abnormally porous bones, thus increasing the fragility of bones and an increase of fractures and breaks. A bone diseased with osteoporosis will have a density similar to that of a sponge, whereas healthy bones have a brick-consistent density level. Bones are made up of collagen, calcium and protein to ensure strength. Avandia was found to inhibit the development of osteoclasts and osteoblasts, which are cells that induce the redevelopment of healthy bone over time. It has been suggested that nearly 18 million Americans are at risk for osteoporosis and those taking Avandia increase that risk as well as the odds for early onset osteoporosis.

The Swiss researchers used medical records of over 1,000 diabetic patients who were diagnosed with bone fractures between the years of 1994 and 2005. The medical records included diagnosis of fractures for these patients from British physicians, and the research was compared to a control group of diabetics that did were not diagnosed with bone fractures during that time. Since these reports began to surface the manufacturer has seen a noticeable decline in sales. Most recently, the U.S. Food and Drug Administration (FDA) issued a warning letter to GlaxoSmithKline after a routine inspection turned up information being withheld by the company to the FDA on Avandia.

Although, the FDA has yet to address the new research on the osteoporosis and bone fracture risk of Avandia. In fact, the FDA has only responded to the controversial heart disease link by placing a black box warning on Avandia prescriptions, which some health experts consider to be a mild slap on the wrist considering the severe safety issues associated with the drug and many of these individuals are advocating removal of the drug from the market. The black box warning is the strongest label given by the FDA and warns of significant risk and the potential for life-threatening risks associated with taking a drug.

Individuals who have taken Avandia and who were adversely affected by the side effects of osteoporosis and bone fracture should speak with a pharmaceutical attorney about developing Avandia litigation to potentially receive monetary compensation for the medical bills incurred at the cost of the Avandia side effects.

GlaxoSmithKline: Avandia Unlikely to Recover

2007-08-11T06:03:02Z

The U.S. Food and Drug Administration recently voted to keep Avandia on the market. Avandia is a drug manufactured by GlaxoSmithKline and it is used to treat type 2 diabetes. However, though the news would seem positive for GlaxoSmithKline, the FDA's treatment of the situation has called into question the FDA's ability to manage situations such as these and the review likely will damage Avandia sales.

]]> The FDA's panel meeting was prompted by a meta analysis conducted by Dr. Steven Nissen. Nissen's report was published in the New England Journal of medicine in May. Many medical specialists have stopped prescribing Avandia to patients as a result of the study.

Warning Label Urged for Avandia

2007-08-10T05:16:12Z

A U.S. Food and Drug Administration panel has concluded that diabetes patients taking the drug Avandia to treat their condition have a greater risk of heart attack than those taking other drugs to treat their conditions. While the panel did not advise removing the drug from the market, they did say that Avandia needs a stricter warning on its label.

Warning Label Urged for Avandia

]]> The panel's recommendation likely will only cause more problems for GlaxoSmithKline, the manufacturer of Avandia. Increasing information suggests that GlaxoSmithKline was aware of the dangers of Avandia more than a year before a report linked Avandia to increased heart and kidney risks. More than 20 million Americans and about 170 million people around the world have diabetes.

Reports of Avandia-Related Heart Attacks Jumps

2007-08-10T03:52:22Z

The side effects noted by patients taking diabetes drug Avandia tripled in the months after a study linked the drug to increased rates of heart attacks. A report from the U.S. Food and Drug Administration says: "In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped... Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet."

Reports of Avandia-Related Heart Attacks Jump, Highlight Flawed FDA Monitoring

]]> The reports may indicate that doctors who were previously unfamiliar with the side effects of Avandia began to report side effects that they had believed to be unrelated to Avandia. However, it is not possible to determine much more than that from the report, though the report is suggestive of the fact that the FDA needs to change its post-approval drug monitoring process.

Class Action Filed Against Avandia

2007-08-09T04:07:11Z

A class action lawsuit has been filed against GlaxoSmithKline, saying that the drug company did not do enough to alert those taking the drug of the drug's risk. The lawsuit was filed at the Court of Queen's Bench in Regina on the behalf of a 75-year-old woman who died in May after having taken Avandia.

Class Action Suit Launched Over Avandia

]]> Avandia was approved for the treatment of Type 2 diabetes in March 2000. Tony Merchant, the lawyer representing the plaintiff's estate, says of the lawsuit: "People have to have informed consent. They have to know what the risks are ... And that affords people the opportunity to really decide. That's where we think Avandia fell down." A spokesperson for GlaxoSmithKline in Toronto says that the company has not yet heard of any Canadian class action lawsuit.

FDA Gave Glaxo Extra Year to Profit from Avandia

2007-08-08T04:45:23Z

A memorandum acquired by the Senate Finance Committee shows that Food and Drug Administration knew that there were dangerous side effects associated with GlaxoSmithKline drug Avandia. The memo shows that Dr. David Ross, a FDA reviewer, recommended that there be a highlighted boxed warning on Avandia packaging about an increased risk of CHF. CHF is a life-threatening condition that occurs when fluid builds in the lungs and causes a shortness of breath.

FDA Gave Glaxo Extra Year to Profit Off Avandia]]> The memo also recommended that a warning about an increased risk for macular edema be added to Avandia's packaging. Even though the recommendations were approved by Dr. Rosemary Johann-Liang, they never were added to Avandia's label. Congestive heart failure "is a very, very clear adverse reaction syndrome" with Avandia, said Johann-Lang. Johann-Lang has since left the FDA.

Avandia- FDA Controversy Causes Questions of Comeback

2007-08-08T03:18:31Z

The U.S. Food and Drug Administration decided this week that GlaxoSmithKline's diabetes drug Avandia shall remain on the market, but will carry more warnings on its label. Avandia recently was linked to increased heart and kidney problems in those who take the drug to manage their diabetes. Shares of GlaxoSmithKline had their biggest gain in two years after the FDA advisory panel decided not to withdraw Avandia from the market.

Glaxo Avandia FDA Adversity Fuels Doubts of Comeback

]]> The news causes questions for GlaxoSmithKline: will the drug company's stock market value ever recover to its value prior to the Avandia scandal? Pascale Boyer Barresi, an analyst at Bordier & Cie, says "Glaxo probably will receive a black-box warning and the sales will probably not recover to the previous level. [Avandia sales] will probably recover 10 to 15 percent, but the decline was so far that I think once doctors have changed their patients, they will not switch back."

Diabetes Drug May Cause Heart Problems

2007-08-07T05:18:13Z

A month after a study found a possible link between heart attacks and GlaxoSmithKline's diabetes drug Avandia, the number of reported side effects tripled. Dr. Ronald Goldberg from the University of Miami Diabetes Research Institute says that diabetes patients are excited to switch medications. Goldberg says that when he explains the risks possibly associated with Avandia to patients, they "tend to feel more comfortable going off to a different medicine, a different oral medicine."

]]> At Baptist Medical Arts pharmacy, the pharmacists say that they have seen about a 50 percent decline in the number of Avandia prescriptions. Goldberg, however, says that he only is insistent that patients switch drugs in a few cases: "The only situation where I'm a little bit more insistent that they change is if they have cardiovascular disease," he said. "That might be the group where it's most prudent to insist on a change until we know more."

Is Avandia Safe? Depends Who You Ask.

2007-08-07T02:43:14Z

A majority of the recent federal drug panel has voted to keep Avandia on the market. Data from recent studies have linked Avandia to increased risk of heart and kidney problems. The panel advises that Avandia remain on the market, but with more warnings on its labeling.

Is Avandia Safe? Depends Who You Talk To?

]]> Dr. David Graham testified at the federal drug panel on July 30. He said of Avandia: "It's well established that rosiglitazone increases congestive heart failure." GlaxoSmithKline, the manufacturer of Avandia, reiterates its position that Avandia is safe. Since Steven Nissen's report in the New England Journal of Medicine implicated Avandia for increasing heart and kidney problems, further studies have indicated similar results. Sales of Avandia have fallen drastically since Nissen's report was made public.

Avandia Heart Risks May Be "Inconclusive"

2007-07-13T20:24:44Z

Researchers from the New England Journal of Medicine are reporting that data on Avandia's overall heart risks are "inconclusive." Researchers say that they have not yet established if there is an association between Avandia and heart attacks or Avandia and heart disease in general. The Food and Drug Administration says that Avadia and another diabetes drug, Actos, will be required to carry a "black box" warning about the heightened heart attack risk from taking the drug.

Avandia Heart Risks May Be "Inconclusive"

]]> In May, researchers conducting an interim study found that Avandia appeared to increase the risk for heart problems. The maker of Avandia, GlaxoSmithKline, says that the findings are flawed because the data that was analyzed was not specifically looking for heart risk. A more recent study in which half of the participants took Avandia and a combination of metformin and sulfonylurea and the other half of the participants only took sulfonylurea-metformin found that there was not an increased risk of heart attack or heart problems in general in patients who were taking Avandia. However, heart failure was 2.15 time more common in the Avandia group.

Avandia May Get Bone Warning

2007-07-12T21:11:57Z

GlaxoSmithKline Plc's diabetes drug Avandia may soon have a warning label to consumers advising that the drug causes an increased risk of bone fractures. A recent study shows that Avandia leads to an increased risk of broken bones in women. The effect has not yet been studied in men.

Glaxo's Avandia May Get Bone Warning, Analyst Says

]]> Andrew Baum, a Morgan Stanley analyst, says that the new data "suggests that thiazolidinedione treatment is a risk factor and can contribute to excess incidence of fractures in diabetes." Baum is "almost certain" that Avandia will get a new warning about fracture risks in women on its label. GlaxoSmithKline, the manufacturer of Avandia, says that the study's conclusions are "limited" and that any clinical relevance cannot yet be determined.

Congress Works to Balance Drug Safety and Fast Approval

2007-07-07T21:22:59Z

The recent safety concerns over Vioxx, Ketek, and Avandia are highlighting the longstanding debate on how prescription medications should be approved for use by American consumers. The safety of the three drugs was called into question after the Food and Drug Administration approved them for use. Vioxx has been implicated in thousands of heart attacks, Ketek causes liver failure, and the health hazards of Avandia have only just begun to be realized.

Congress Seeks to Balance Drug Safety, Quick Approval

]]> Jerry Avorn, a Harvard Medical School physician, says that he is "deeply disappointed in the way things are headed." He believes that not enough money is spent on "pharmocovigilance;" the term refers to the ongoing study of drug safety.

New Data Show Those Taking Avandia Had Lower Medical Costs

2007-07-06T07:58:02Z

Recent data from more than 15,000 patients with type 2 diabetes show that initial therapy with Avandia was associated with significantly lower medical costs and total visits to the doctor compared to patients who were treated with a sulfonylurea. Dr. Mel Sheng Duh, the co-author of the study, said, "the study findings demonstrate that treatment with Avandia resulted in significantly lower total medical costs for the patient over time, when compared to sulfonylurea therapy. These data are important to physicians selecting treatment for their patients because the financial burden of diabetes and its associated health problems is staggering -- not only to patients but to their families and the healthcare system as well."

New Data Show Patients Treated With Avandia(R) (Rosiglitazone Maleate) Incurred Lower Medical Costs and Used Fewer Healthcare Resources When Compared to Patients Treated With Sulphonylureas

]]> Main findings from the study indicate that the total direct medical costs were significantly lower in the group taking Avandia compared to the sulfonylurea group. The study looked at real-world medical, pharmacy, and disability insurance claim data from more than 3,000 patients treated with Avandia.

Avandia Maker Sued Over Heart Attack

2007-07-05T07:29:15Z

Larry Alan Stanford's widow and son are suing GlaxoSmithKline, the maker of the diabetes drug Avandia. Peggie Stanford, Larry's widow, says that her husband died as a result of having taken the drug. Larry Stanford died on May 21 from a heart attack. Stanford had been taking Avandamet, a form of Avandia, combined with another diabetes drug, since early 2005.

Avandia Maker Sued Over Heart Attack

]]> Stephen Drinnon, the lawyer representing the Stanfords, says that he "believes the evidence will show the company knew there were problems with Avandia but decided to keep on selling it to Larry and others." A GlaxoSmithKline spokeswoman responded that the company will "vigorously defend our medicine."

Understanding How PPAR-Gamma Agonists Work

2007-07-04T19:21:32Z

The peroxisome proliferator-activated receptor, PPAR-gamma agonist, class of drugs is the fastest-growing class of drugs in the type 2 diabetes market. Currently, GlaxoSmithKline's Avandia and Takeda's Actos are the fastest-growing class of drugs in the type 2 diabetes market.

Understand How Recent Safety Concerns Will Affect PPAR-Gamma Agonists

]]> Recent evidence has suggested that Takeda's Actos actually lowers heart risk. This calls into question what makes Avandia a dangerous drug, if it is even a dangerous drug.