The diabetes drug Avandia has been linked to so many health problems that some have questioned whether or not it should be on the market at all.

In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning. The warning followed an analysis of 42 clinical trails published by the Cleveland Clinic in May 2007 that found patients taking Avandia had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. (more…)

The risk of bone fracture in individuals taking thiazolidinediones has again been suggested in another recent study. Science Daily just reported that research published this week in PLoS Medicine discussed the risk between the type 2 diabetes drugs and bone fracture. Thiazolidinediones—known as TZDs—were introduced in the 1990s and include such popular medications as Avandia (rosiglitazone) or Actos (pioglitazone).

The study, led by Ian Douglas of the London School of Hygiene and Tropical Medicine—reviewed, said Science Daily, the General Practice Research Database, which is a listing of clinical records of over six million patients registered at 400 general practice surgeries in the United Kingdom. (more…)

Another study involving Avandia has found an increased risk of heart failure among patients taking the controversial diabetes drug. The Canadian study was published this month in the British Medical Journal.

Avandia’s cardiovascular side effects first became the subject of concern in May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning. (more…)

The diabetes drug Avandia carries more risk than Actos, a new study conducted by Canadian researchers has found. According to a Reuters report, seniors in the study taking Avandia were more likely to suffer from heart failure, and were more likely to die. The findings prompted the authors of the study to question the continuing use of Avandia.

According to Reuters, researchers at Sunnybrook Health Sciences Centre in Toronto analyzed six years of records for nearly 40,000 patients aged 66 years and older. They found that for every 93 patients given Avandia rather than Actos there would be one additional cardiovascular event or death each year. No significant difference in the risk of heart attack between Avandia and Actos was found. (more…)

Another large, panel study has revealed an increased risk of fracture associated with thiazolidinediones (TZDs), which are used to treat type 2 diabetes. The study, which took place in British Columbia, Canada, appears in the August 10/24, 2009 issue of the Archives of Internal Medicine, said The Heart. TZDs are a class of diabetes drugs that includes Avandia and Actos.

The study, said the Heart, looked at fracture risk in over 84,000 patients who received Avandia (rosiglitazone) or Actos (pioglitazone) over a sulfonylurea. The study revealed that men and women experienced an increased risk of fractures when taking a TZD and found that Actos could actually be responsible for an increased fracture risk, said the Heart. (more…)

According to emerging research, GlaxoSmithKline’s diabetes drug, Avandia, can cause death as a result of liver failure, and should be banned by the U.S. Food & Drug Administration (FDA). The group, Public Citizen, published the research in the peer-reviewed medical journal Pharmacoepidemiology and Drug Safety.

According to Public Citizen, it petitioned the FDA to ban Avandia as far back as October due to its risks, including heart attack, heart failure, and liver toxicity, noting that these risks “far outweigh its benefits,” especially given that there are safer medical alternatives for the treatment of Type 2 diabetes. The study discussed 11 cases of severe liver toxicity, mostly fatal, that were associated with Avandia (generic: rosiglitazone) use, said Public Citizen. (more…)

A newly published Avandia study has found that the controversial diabetes drug “significantly” raises the risk of heart failure and fractures. But unlike previous research, this study did not find that people taking Avandia were at a higher risk of heart death, and was unable to determine if the Avandia patients in the study had a higher chance of heart attack. However, according to a report on WebMD, the study – known as RECORD- is causing some controversy because it was funded by GlaxoSmithKline, the maker of Avandia.

Avandia’s cardiovascular side effects have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning.

Concerns over Avandia’s safety had prompted the American Diabetes Association to advise against prescribing Avandia in favor of Actos, another drug in the same class, WebMD said. But now, the Association may reconsider that stance in light of the RECORD study.

According to an article on usnews.com, the Website of U.S. News and World Report, the RECORD study involved 4,447 patients with type 2 diabetes, randomly selected to take Avandia plus metformin and sulfonylurea or just metformin and sulfonylurea. The study was not blinded, meaning that study investigators and patients knew which treatment they were getting, WebMD said.

At a news conference announcing the RECORD results, Dr. Philip D. Home, chairman of the study steering committee and a professor of diabetes medicine at Newcastle University in Britain said Avandia “clearly has a role, alongside other drugs [in the treatment of diabetes], provided you obey the contraindications, which are not to use it in people with heart failure and to think twice for people at high risk for fractures.”

But not everyone is so sure. Dr. Stephen Nissen, who conducted the 2007 study that first found an increase risk of heart attacks among Avandia users, is among them. According to usnews.com, Nissen called the RECORD study “seriously flawed” because more patients in the Avandia group were taking cholesterol-lowering statins and that group had what looked to be a high drop-out rate. “Obviously, it is impossible to assess the safety of a drug when patients are not actually taking it,” Nissen said.

In the same report, Dr. Suzanne Steinbaum, director of women and heart disease at Lenox Hill Hospital in New York City, said that determining which patients might safely use Avandia might prove difficult, as type2 diabetes already puts people at a higher risk of heart disease.

Avandia lawsuits continue to be filed in courts around the country. Two just filed in Illinois involve a whopping 186 plaintiffs. Another Avandia lawsuit in Texas claims the dangerous diabetes drug is not worth its risks.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline, the maker of Avandia and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a Black Box warning detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling.

Since the May 2007 study highlighting Avandia’s heart risks was released, thousands of people injured by the drug have filed lawsuits against Glaxo. The two Illinois lawsuits were filed May 15 in Illinois state court. The 186 plaintiffs in the lawsuits allege Glaxo failed to warn of potential serious side effects from which they or their deceased relatives suffered.

As a result of their ingestion of the drug, the plaintiffs say they became ill and were impaired in their health, strength and activity. They also incurred medical costs, lost wages, suffered disabilities and experienced pain, according to the complaints. The plaintiffs maintain Glaxo should have provided warnings on Avandia’s heart risk before the FDA required the company to do so, especially since the company knew that most people with diabetes have risk factors such as high blood pressure and cholesterol that provide a susceptibility for heart disease and stroke.

In both Illinois lawsuits, the plaintiffs are seeking a judgment in excess of $450,000, plus costs, attorney’s fees and other relief the court deems just.

The Texas lawsuit, filed on May 13 in the U.S. District Court of the Eastern District of Texas, Texarkana Division, involves a man who had to have heart bypass surgery after having taken Avandia for five years. The lawsuit alleges that Glaxo employed a “spectacular” marketing and distribution strategy despite knowing that “its drug was unreasonably dangerous and that the diabetic patient population was uniformed of the dangers.”

“Defendant Glaxo did not provide sufficient warnings and instructions that would have put Plaintiff and the general public, on notice of the dangers and adverse effects caused by ingesting [Avandia], including without limitation to risk of heart attack,” the lawsuit states.

The lawsuit claims that Avandia is defective in design and unreasonably dangerous and states that the risks of using Avandia far outweighed the benefits.

Recent reports point to GlaxoSmithKline long being aware of Avandia’s cardiac risks.  In 2007, a Cleveland Clinic study conducted by prominent cardiologist Dr. Steven Nissen and published in the New England Journal of Medicine (NEJM) found that patients taking the diabetes drug experienced a 43-percent higher risk of suffering a heart attack.  Many called for Avandia’s recall, but as Wall Street Journal (WSJ) reports today, Glaxo argued against the findings.  Now, some details of Glaxo’s behind-the-scenes Avandia cover-ups are being made public.

Glaxo emails prove its own researchers were worried its findings mirrored Nissen’s study says the WSJ.  Following release of the study, both Glaxo and the U.S. Food & Drug Administration (FDA) came under fire for a failure to warn the public about Avandia’s risks.  Also, 2007 Congressional testimony revealed both groups knew about the cardiac risks in 2005 and an FDA scientist who advocated for a strong black box warning alleged that the damaging information was removed from an Avandia safety review.  Just before the study was published, reports WSJ, Glaxo’s senior consultant wrote in an email, “The numbers are the numbers, the analysis is very similar to our own.” (more…)

New diabetes drugs will now have to be screened for heart risks before they can be approved, the Food & Drug Administration (FDA) said yesterday.  The new testing standards do not apply to drugs already on the market, including Avandia and Actos, two medications that have been linked to heart problems.

According to the FDA, more than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia. (more…)