Avandia Trial in Trouble
-PharmExec
04/21/2010 - GSK’s Avandia just won’t stay out of the news. Now comes a report from The Wall Street Journal that the FDA is considering dealing the beleaguered diabetes drug another blow by stopping one of its safety trials. The TIDE trial, which received approval in 2007, pits Avandia (rosiglitazone) against Takeda’s Actos (pioglitazone), a drug that as yet hasn’t suffered from the same safety pitfalls. More>>>
Avandia testing faces new questions
- Philadelphia Inquirer
04/20/2010 - U.S. regulators are reviewing the safety of GlaxoSmithKline P.L.C.'s Avandia diabetes drug as they weigh whether to suspend a trial testing the medicine, Bloomberg News reported. The Food and Drug Administration is reassessing a study comparing Avandia with a rival medicine from Takeda Pharmaceutical Co., and whether it is ethical to pursue the research after studies tied the Glaxo drug to an increased heart attack risk, according to a letter from FDA Commissioner Margaret Hamburg, dated March 30, the news service said. More>>>
Avandia and the Heart: A Reminder That Drugs Can Harm
-The Huffington Post
03/31/2010 - Diabetes is particularly detrimental to the heart, and heart problems are the eventual cause of death for most patients with diabetes. Given this, it is extremely worrisome that Avandia, a drug marketed to treat diabetes, has been found to harm the heart. More>>>
Is Avandia Harmful for The Heart?
-HSJ
03/25/2010 -Avandia is a diabetes drug that is usually given to senior citizens. It helps control blood sugar levels by making the cells of the body more sensitive to the action of insulin. Avandia is for people with Type 2 (non-insulin dependent) diabetes. It is sometimes used in combination with other medications, but it is not for treating Type 1 diabetes. However, there are recent studies that Avandia is harmful for the heart, and increases the chances of getting a heart attack. More>>>
Many Avandia defenders have drug co. ties –study
-Reuters
03/19/2010 - Virtually all of the experts who wrote favorably about GlaxoSmithKline Plc's troubled diabetes drug Avandia had financial ties to drug makers, a finding that shows the need for reform of such relationships, U.S. researchers said on Thursday. More>>>
UBS Says Avandia lawsuits pose up to $6B risk to GS
-Ennislaw
03/15/2010 - The UBS (Union Bank of Switzerland) reported publicly last week that pharmaceutical giant GlaxoSmithKline PLC could end up liable for more than $6 billion in settlements and compensation for serious health complications caused by the company’s popular diabetes treatment medication Avandia. The type-2 diabetes prescription drug has been linked with severe heart problems, including heart attacks. More>>>
Questions raised about ongoing Avandia studies
CTV.ca
03/03/2010 - While health regulators in both Canada and the U.S. wrangle over what to do about the diabetes medication Avandia, some are raising concerns about why clinical studies are still recruiting patients to test the controversial drug. Avandia, or rosiglitazone as it's known generically, was once heavily promoted for Type 2 diabetes because it helps to lower blood-sugar levels in patients. But it has come under intense scrutiny in recent years. More>>>
Remove Diabetes Drug Avandia From Market: FDA Reports
Controversial medicine Avandia raises users' heart risk, leaked documents suggest
-HealthDay News
02/20/2010 - The blockbuster type 2 diabetes drug Avandia raises users' odds for heart attack and heart failure and should be removed from the market, according to confidential government reports. The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking (rosiglitazone) Avandia switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month. More>>>
Senate report links diabetes drug Avandia to heart attacks
-CNN
02/20/2010 - The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report released Saturday. More>>>
Controversial Diabetes Drug Avandia Harms Heart, U.S. Concludes
-The New York Times
02/19/2010 - 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. More>>>
Avandia Heart Attack Risks Lead To Side Effects Lawsuit Local resident's Avandia lawsuit part of national effort
-Gary Post Tribune
12/30/2009 - A local resident's lawsuit against a drug maker for not properly warning patients about how its product increases the risk of heart attacks is joining hundreds of similar lawsuits across the country. More>>>
Diabetes drugs may leave heart at greater risk
Working harder to lower blood glucose in Type 2 diabetics doesn't help the heart, studies say.
-LA Times
10/24/2009 - Medications for Type 2 (adult-onset) diabetes are very effective at controlling blood sugar levels. You'd think, then, that the drugs would also be very effective at controlling complications of the disease related to those spikes in blood sugar: cardiovascular disease, kidney failure, blindness, nerve damage and amputation of limbs. Surprisingly, though, that has not turned out to be the case for cardiovascular events such as heart attacks and strokes. More>>>
Confusing Choices for Doctors and Type 2 Diabetes Patients
-GEN
10/23/2009 - Given the current worldwide type 2 diabetes epidemic, it’s hard for drug developers to ignore the huge potential for new, better, and safer oral drugs. The U.S. market alone has reached $5 billion annually, and the prevalence of type 2 diabetes continues to rise across the globe. More>>>
Study finds certain diabetes drugs may cause bone fractures
-DrugStoreNews
10/01/2009 - A certain class of diabetes drugs may put patients at higher risk of bone fractures, according to a study published in the online edition of the journal PLoS Medicine. More>>>
Avandia Study Shows Increased Risk Of Heart Failure
-Ennis & Ennis, P.A.
-J.Murawski
09/28/2009 - Avandia is marketed by GlaxoSmithKline for the treatment of Type 2 diabetes. Recently however, studies have shown that Avandia significantly increases the risk of heart attack and heart related deaths. More>>>
Diabetes drug could lead to heart failure: Study
-CalgaryHerald
09/26/2009 - New research involving nearly 40,000 Ontario patients is questioning the use of a widely prescribed diabetes drug that an expert in drug safety says should be removed from the market. The study, published this week by the British Medical Journal, found that rosiglitazone — sold under the brand name Avandia — is associated with an increased risk of heart failure and death compared to a similar drug, pioglitazone, or Actos. More>>>
Prescription Avandia Has Been Linked To Cases Of Serious Side Effects And Fatalities
The prescription drug Avandia (rosiglitazone) causes an increase in liver problems, heart problems and bone density problems resulting in fractures
-OfficialWire
09/24/2009 - The prescription drug Avandia (rosiglitazone) causes an increase in liver problems, heart problems and bone density problems resulting in fractures. It has been linked to cases of death due to liver failure and heart failure. Patients who have taken Avandia should be aware of possible side effects and should know when to seek treatment for serious Avandia related health problems. More>>>
Diabetes drug linked to heart failure risk
-UPI
08/25/2009 - Canadian scientists say they have discovered rosiglitazone (Avandia) a type 2 diabetes drug, might be linked with increased risk of heart failure and death. The scientists from the University of Toronto and the Sunnybrook Health Sciences Center in Toronto, said the linkage was found among older patients, compared to a similar drug, pioglitazone (Actos). More>>>
Researchers decry use of diabetes drug Avandia
-The Canadian Press
08/23/2009 - Some Ontario researchers are calling into question the continued use of the controversial diabetes drug Avandia, saying a competing drug in the same class is as effective and less dangerous. The scientists, from Toronto's Institute for Clinical Evaluative Sciences, said people taking Actos or pioglitazone for Type 2 diabetes are 23 per cent less likely to be hospitalized for heart failure and 14 per cent less likely to die than people taking Avandia or rosiglitazone. More>>>
Stop prescribing killer diabetes drug, scientists warn:
Rosiglitazone, brand name Avandia, has higher rates of heart failure and death than similar alternative
-Guardian UK
08/20/2009 - Scientists say doctors should stop prescribing a commonly used diabetes drug, after studies show that it is linked to higher rates of heart failure and death than a similar alternative. More>>>
Rosiglitazone safety questioned, again, this time in population-based study
-TheHeart.org
08/20/2009 - Toronto, ON - The risk of dying or being hospitalized with heart failure, but not of MI, is lower among older diabetic patients taking pioglitazone (Actos, Takeda Pharmaceuticals North America) than in those taking rosiglitazone (Avandia, GlaxoSmithKline), suggests a retrospective analysis based on outpatient data from across Ontario. More>>>
Diabetes drug could lead to heart failure: Study
-The Vancouver Sun
08/19/2009 - New research involving nearly 40,000 Ontario patients is questioning the use of a widely prescribed diabetes drug that an expert in drug safety says should be removed from the market. The study, published this week by the British Medical Journal, found that rosiglitazone — sold under the brand name Avandia — is associated with an increased risk of heart failure and death compared to a similar drug, pioglitazone, or Actos. More>>>
Glaxo's Avandia riskier than Takeda drug -study
-Reuters
08/19/2009 - GlaxoSmithKline Plc's diabetes drug Avandia is associated with an increased risk of heart failure and death among older patients compared with Takeda Actos, according to Canadian research. More>>>
TZDs may increase risk for fracture in men, women
-Endocrine Today
08/17/2009 - Men and women who are exposed to thiazolidinediones may be at increased risk for fractures, especially with pioglitazone. A prospective cohort study examined risk for fractures in 84,339 adults (mean age, 59; 43% women) from British Columbia, Canada, who began treatment with a TZD or sulfonylurea. More>>>
Diabetes drug Avandia comes under new criticism
-LA Times
07/25/2009 - The diabetes drug rosiglitazone, already under fire because it has been found to increase the risk of heart attacks, can also produce liver failure and death in some patients, researchers from the activist group Public Citizen said this week. More>>>
No new Alzheimer's indication for Avandia
-FiercePharma
07/13/2009 - Poor Avandia. The GlaxoSmithKline drug failed an Alzheimer's disease trial, dashing the company's hopes of a new indication and up to $300 million in additional sales. "We saw no efficacy in this study, or the two adjunct trials," Michael Gold, Glaxo's vice president of neurosciences, told Bloomberg. More>>>
Glaxo’s Avandia Fails to Benefit Alzheimer’s Patients in Study
-Bloomberg
07/12/2009 - GlaxoSmithKline Plc’s diabetes drug Avandia failed to benefit patients with Alzheimer’s disease, according to a company-funded study. The findings are another setback for Avandia, once the biggest-selling drug for diabetes in the world, and raise questions about the theory that Alzheimer’s is a form of diabetes of the brain. Sales of Avandia haven’t recovered since a study linked the drug to heart attacks in May 2007. More>>>
5 Risks Linked to Diabetes Medications Like Lantus, Avandia, Actos: Cancer, heart failure, fractures, and eye and liver problems among some diabetes drugs' possible risks
-U.S.News
07/07/2009 - For the 200 million diabetics worldwide, the past few years have brought some disturbing findings about risks that may be associated with certain diabetes drugs. Recent concerns that Avandia (rosiglitazone) might cause cardiovascular problems, for example, have led some experts to call for it to be pulled from the market, although it remains available today. More>>>
Diabetes debate
-Indian Express
07/06/2009 - In a new study, GlaxoSmithKline refuses to accept the claim that its product Avandia puts patients at high risk of heart attacks; diabetologists say the final word is not yet out. More>>>
FDA wants additional study of diabetes drug
-ChicagoTribune
06/27/2009 - In a blow to the diabetes treatment franchise of a Deerfield drug maker, the U.S. Food and Drug Administration has asked Takeda Pharmaceuticals North America Inc. to conduct an additional heart safety trial of its experimental drug alogliptin, the company said this afternoon. More>>>
Diabetes drugs can lead to heart failure
-TheMedGuru
06/25/2009 - A latest study has revealed how a certain category of diabetes drugs can actually increase the risk of heart failure. The class of drugs under study were thiazolidinediones (TZDs). More>>>
How diabetes drugs raise heart failure risk
-ThaindianNews
06/23/2009 - A new study may help explain how a class of diabetes drugs increases the risk of heart failure. Thiazolidinediones (TZDs) have been controversial since a 2007 analysis of Avandia (rosiglitazone), a TZD made by GlaxoSmithKline, suggested that patients taking it are at higher risk of heart attack. More>>>
GSK: RECORD trial results do not change Avandia’s CV risk stigma, bone fracture risk, physicians say
-Pharmawire
06/19/2009 - The final results of the RECORD study demonstrated that overall rates of cardiovascular (CV) hospitalization and cardiovascular death - the two primary endpoints - were similar in patients taking Avandia (rosiglitazone) compared to those receiving metformin and sulfonylurea. More>>>
Recent study links Avandia and Actos to increased bone breaks
-Examiner - Knoxville
06/15/2009 - Be careful!Dr. Merri Pendergrass presented a study of bone fractures in close to 70,000 patients taking either rosiglitazone (Avandia) or pioglitazone (Actos) at the 2009 American Diabetes Association Scientific Sessions. Fracture risk appears to be increased by 40% for patients taking these medications. More>>>
More evidence links glitazones to broken bones
-WebMD – theheart.org
06/13/2009 - New Orleans, LA - The largest study to date looking at whether the risk of bone fractures is increased in the setting of thiazolidinedione drugs (TZDs) suggests that fracture risk is more than 40% higher in people taking TZDs and that both men and women are vulnerable. More>>>
Docs say Avandia fears aren't laid to rest
-FiercePharma
06/09/2009 - Doctors aren't so sure that the Avandia-exonerating safety study is as conclusive as presented at the American Diabetes Association meeting. Some physicians are calling the study "flawed." In an editorial in the Lancet--where the research was published--two doctors wrote that the study's limitations prevent any "definitive conclusions" about Avandia's effects on cardiac safety. More>>>
Avandia Raises Risk of Heart Failure, Fractures
But study found diabetes drug didn't increase chances of heart disease, death
-HealthDay News
06/08/2009 - The diabetes drug Avandia significantly raises the risk of both heart failure and bone fractures, but it does not boost the odds for either cardiovascular disease or death, new research has found. More>>>
Suit against GSK claims Avandia not worth the risks
-SoutheastTexasRecord
05/14/2009 - After taking Avandia for five years, Frank Casteel underwent heart bypass surgery in 2007. Now Casteel is suing the drug's manufacturer alleging that the drug is not worth the risks. More>>>
10 Utahns, 2 others sue pharmaceutical company
-Deseret News
05/02/2009 - Ten Utahns and two people from Oregon filed federal lawsuits Thursday against the pharmaceutical giant GlaxoSmithKline PLC alleging that the company was negligent in researching the drug Avandia, which caused them (or a spouse) to have heart attacks and subsequent health problems. More>>>
Low blood sugar a dementia risk for diabetics
-The Malaysian Insider.
04/14/2009 - Older diabetics whose blood sugar drops to dangerously low levels have a higher risk of developing dementia, US researchers said today. The study by researchers at Kaiser Permanente in Oakland, California, suggests that aggressive blood sugar control resulting in blood sugar so low it requires a trip to the hospital may increase dementia risks in older adults with type 2 diabetes. More>>>
Diabetes drug class linked to vision-threatening complication
-EurekAlert
04/02/2009 - Treatment with the glitazone class of diabetes drugs leads to a "modest" increase in the risk of diabetic macular edema (DME)—a common complication that can lead to vision loss, reports a study in the April issue of the American Journal of Ophthalmology (http://www.elsevier.com/locate/ajo), published by Elsevier. More>>>
Avandia Causing Havoc For Patients
-LawyersandSettlements
03/18/2009 - Centerview, MO: As more lawsuits are filed against the maker of Avandia alleging the drug caused irreparable harm to patients, more patients are wondering if they too have suffered an Avandia heart attack or other Avandia side effects. Meanwhile, public interest groups are encouraging patients to avoid the drug and return to older medications that do not have as many complications. More>>>
Review of Heart Side Effects for Diabetes Drugs Lead to Delay for Proposed Takeda Medication
-AboutLawsuits
03/09/2009 - Following the discovery of heart problems with Avandia and other diabetes drugs, the FDA is requiring that drug makers establish that proposed diabetes medications do not increase the risk of cardiovascular side effects, even if the New Drug Application was filed before the new guidance was issued in December 2008. More>>>
Avandia Health Problems "Frustrating"
-LawyersandSettlements
02/12/2009- Pine Mountain Valley, GA: Dave J. (not his real name) says he is not sure how long he took Avandia for, but he says he was definitely on the medication for a while. Since he took Avandia, Dave has had a number of medical problems, including at least one massive stroke. Following his medical problems, Dave has been unable to return to any of his jobs, which included being a high school teacher, an adjunct professor and a part-time deputy with the sheriff's office. More>>>
Heart risk of diabetes drugs
-BMJ Group
01/21/2009- Two medicines used to treat people with diabetes can increase the risk of serious side effects, new research has found. Rosiglitazone (brand name Avandia) and pioglitazone (Actos) are medicines for type 2 diabetes. More>>>
Glaxo EMails Show That Scientist Knew About Avandia
-InjuryBoard
01/14/2009-The Wall Street Journal reported on January 14 that internal emails from GlaxoSmithKline's scientists show that at the time that Glaxo was publically dismissing the notion that its diabetes drug, Avandia, posed an increased risk of heart attacks, its own scientists expressed concerns that Glaxo's own data was showing the same thing. More>>>
Actos Heart Failure Warning Strengthened in Canada
-AboutLawsuits
12/22/2008- Health Canada has said that the warning label information about potential Actos heart failure side effects will be strengthened to indicate that the diabetes drug should not be used in patients with pre-existing heart failure or taken together with metformin and a sulfonylurea. More>>>
Diabetes Drugs Must Now Clear Cardiovascular Hurdle, Says FDA
-heartwire
12/19/2008- The Food and Drug Administration is now recommending that all new drugs developed for the treatment of type 2 diabetes show that they do not increase the risk of cardiovascular events. More>>>
Diabetes: Major drugs cause bone loss and fractures
-WDDTY
12/18/2008- The major drugs for treating type II diabetes can cause bone loss and fracture, a new study has discovered. The effects can occur within just a year of taking the drugs. More>>>
Two Diabetes Medications Double Fracture Risks in Women
-HealthNews
12/14/2008- If you have diabetes you might want to ask your physician to review the risks of the medications before taking them. Two widely prescribed medication for diabetes, Actos and Avandia, have both been shown to double the risk of fractures among women. The fracture risk did not increas for men. More>>>
Avandia, Actos May Impact Bone Density In Women
-InjuryBoard
12/10/2008- The widely prescribed diabetes drugs Avandia and Actos have been in the news lately because of concerns about the risk for heart failure. Now a British analysis finds Avandia and Actos double the risk of fractures in women, not in men. More>>>
Diabetes drugs double women's fracture risk
- USA Today
12/09/2008- 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. More>>>
Avandia Death Risk Higher Even When Compared with Actos
-AboutLawsuits
11/28/2008- New data suggests that even when Avandia is compared with Actos, another diabetes drug in the same class of medications, it carries an increased risk of congestive heart failure and death. More>>>
Safety risks higher with Avandia than Actos -study
-Reuters
11/25/2008- Older diabetics who took GlaxoSmithKline's Avandia to control their blood sugar had a higher risk of death and heart failure while on the drug than those who took Takeda Pharmaceutical's Actos, a drug in the same class, U.S. researchers said on Monday. More>>>
Glaxo Dismisses Avandia Liver Failure Risk
11/03/2008 - Following a petition filed last week by the consumer advocacy group Public Citizen, which called for an Avandia recall due to a risk of liver failure and other life-threatening injuries, GlaxoSmithKline has issued a statement dismissing the claim that there are liver safety issue caused by side effects of Avandia. More>>>
Public Citizen Petitions FDA to Ban Avandia, Cites Life-Threatening Toxicity as Top Diabetes Associations Advise Against Use
- Public Citizen
10/30/2008 - WASHINGTON, D.C. – The Food and Drug Administration (FDA) should immediately ban the dangerous diabetes drug Avandia because it can cause death from liver failure and has many other life-threatening risks that far outweigh its benefits, Public Citizen said in a petition filed today with the agency. More>>>
Avandia – A Slow Killer
-LawyersandSettlements
09/30/2008- Cottage Grove, OR: Robert has lived his whole life without any serious illnesses. And until recently, he considered himself to be a pretty healthy man. Unfortunately, Avandia took that away from him, made him sick, and likely caused the need for triple by-pass surgery. More>>>
Avandia –Two Weeks to Near Death
-LawyersandSettlements
09/18/2008- Canfield, OH: Dennis is just 40 years old. He was diagnosed with type 2 diabetes and was put on Avandia. But after only two weeks on the drug, Dennis experienced shortness of breath and chest pains. He had a heart attack and he thinks Avandia could have been the cause. More>>>
"Avandia Changed My Life Forever"
-LawyersandSettlements
09/17/2008- Pacific Junction, Iowa: Donita has type 2 diabetes, and was on Avandia for over seven years. One heart attack and a triple bypass later, her life has changed forever. More>>>
Discovered Avandia Problems Just in Time
-LawyersandSettlements
09/11/2008- Donita has type 2 diabetes, and was on Avandia for over seven years. One heart attack and a triple bypass later, her life has changed forever, but she's grateful she discovered potential problems with the drug, and got off it before it was too late. More>>>
FDA to List Drugs Being Investigated
-WashingtonPost.com
09/06/2008- The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients. More>>>
03/16/2008 - Donald McEwen was driving on I-480 when he saw an ad on the back of a bus recruiting people for a study on diabetes. More>>>
03/04/2008 - The government's watchdog agency is investigating whether the Food and Drug Administration's drug-review process cleared two blockbuster medications without sufficient proof of their safety or effectiveness. More>>>
"It seems that almost weekly we're getting a safety missive," said Les Funtleyder, an analyst who covers the pharmaceutical industry for trading firm Miller Tabak. "We're almost getting safety fatigue." More>>>
01/31/2008 - Weeks before an influential article was published last year in the New England Journal of Medicine linking the diabetes drug Avandia to a risk of heart attacks, a physician helping peer-review the article broke the Journal's confidentiality rules and leaked a copy to the drug's maker, GlaxoSmithKline PLC. More>>>
Reviewer leaked Avandia study to drug firm
- Nature
01/30/2008 - A peer reviewer for The New England Journal of Medicine (NEJM ) broke confidentiality and leaked a damaging report about the blockbuster diabetes drug Avandia to the drug's manufacturer weeks ahead of publication, Nature has learned. More>>>
Avandia Study Results Were Leaked Early to Glaxo
- CNBC
01/30/2008 - The wall between a prestigious medical journal and a major drug company may have been shattered. More>>>
FDA Procedures Draw Scrutiny
- Wall Street Journal
01/25/2008 - Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the Food and Drug Administration requires to approve drugs -- and may generate pressure on the agency to raise its bar. More>>>