Yourlawyer.com (Actos News)

Class Of Diabetes Drugs That Includes Avandia Linked To Fracture Risk

Wed, 30 Sep 2009 00:00:00 -0700

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.

The team located 1,819 patients aged 40 and older with a recorded bone fracture and who were also prescribed a TZD at least once. The team conducted a “self-controlled case-series study,” which compares the frequency of the event—a fracture—in a demographic over a certain time and when a specific medication—TZDs—is taken versus when the medication is not taken, explained Science Daily. The group was age-adjusted to allow for age-related fractures.

The study revealed that about one and half times as many fractures were reported when people took TZDs versus when TZDs were not taken, said Science Daily. The increased fracture risk occurred in both men and women and affected an array of body areas, reported Science Daily, which also noted that the risk was commensurate with the duration of treatment.

The team concluded that the study’s main advantage was that it removed the potential for differences between those who do and do not take a specific drug, said Science Daily, and that these findings are consistent with others studies in which the TZD-fracture connection was found. The researchers stated that the results "should be taken into consideration in the wider debate surrounding the possible risks and benefits of treatment with thiazolidinediones,” quoted Science Daily.

In August we reported on a large, panel study that also revealed an increased risk of fracture associated with TZDs. That study took place in British Columbia, Canada, and appeared in the Archives of Internal Medicine, according to The Heart. That research team looked at fracture risk in over 84,000 patients who received Avandia or Actos over a sulfonylurea, said The Heart. 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. The U.S. Food & Drug Administration (FDA) asked for a warning on the Actos labeling two years ago to address the risk, noted the Heart. As with the British study, this study found that the risk for fractures increased the longer the patient was on the medication.

In addition to its potential to cause fractures, Avandia has been linked to a long list of other safety concerns. In July we wrote that a prominent consumer advocacy group found that Avandia was associated with death due to liver failure. In June, we wrote about a published Avandia study that found the drug “significantly” raises the risk of heart failure and fractures. 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 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.

FDA Wants New Diabetes Drugs Tested for Heart Risks

Thu, 18 Dec 2008 00:00:00 -0800

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.

Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and the FDA said that none of the diabetic medications currently on the market has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack, the agency said.

The FDA decided to take a look at diabetes drug testing after Avandia was linked to an increased risk of heart attacks. Previously, the FDA required the makers of diabetes drugs to prove they lower blood sugar levels. But the Avandia debacle has led many experts to call on the agency to require drug makers to meet other bench marks, including whether they reduce the risk of cardiovascular problems - the number one killer of diabetics.

"We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," Mary Parks, M.D., director of the FDA Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research, said in a statement announcing the new standards. "FDA's guidance outlines the agency's recommendations for doing such an assessment."

The new guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required. Specifically, the FDA recommends that these studies demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies -- especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.

The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.

The FDA has provided written notice of the recommendations to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatment. The new standards mean that it could take longer for drug makers to bring these new medications to market.

Avandia, Actos Raise Fracture Risk for Women

Wed, 10 Dec 2008 00:00:00 -0800

Women who take the diabetes drugs Avandia and Actos face a higher risk of bone fractures, a new study has found. The fracture problem is just the latest troubling side effect associated with these drugs, which have also been linked to heart problems.

For the study, researchers at North Carolina's Wake Forest University School of Medicine and the University of East Anglia in Britain analyzed 10 previous clinical studies lasting at least a year involving 14,000 patients. According to USA Today, the researchers determined that taking either Avandia or Actos for a year doubled the risk of fractures in women. For those in their 70s, - a group already at a higher risk for fractures - the researchers estimated that one fracture would occur for every 21 women. In women in their mid-50s, the figure equals one fracture in every 55 women.

No increased risk was seen among men who took Avandia or Actos. The researchers speculated that the drugs' interaction with estrogen may have led to weaker bones in women. They called for stronger warnings on drugs' labels about the increased fracture risk.

Both Avandia and Actos are associated with other serious side effects. The labels of both drugs carry strong warnings about their link to heart failure. In May 2007, an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking Avandia had a 43-percent higher risk of having a heart attack. In November 2007, the Food & Drug Administration (FDA) finally ordered that a black box warning detailing Avandia’s heart related risk be added to the drug’s labeling.

In October, the group Public Citizen said it had identified 14 cases of Avandia-induced liver failure in the FDA’s Adverse Event Reporting System. Of the 14 cases of liver failure, 12 resulted in deaths. Those findings prompted Public Citizen to file a petition with the FDA asking that Avandia be removed from the market. The liver failure associated with Avandia, taken together with the drug’s risk of other side effects, including heart failure, fractures and vision loss, was too great to allow the drug to continue to be sold in U.S., the group’s petition said.

In October, the American Diabetes Association/European Association for the Study of Diabetes working group dropped Avandia from its treatment guidelines.

Avandia Linked with Increased Risk of Death, Heart Attacks

Tue, 25 Nov 2008 00:00:00 -0800

According to a study published in a recent issue of the Archives of Internal Medicine, the diabetes drug rosiglitazone maleate—also known as Avandia—may increase the risk of certain cardiovascular events.

The study, which was conducted by Dr. Wolfgang Winkelmayer of Brigham and Women's Hospital in Boston and colleagues, involved patients aged 65 and older who had taken either Avandia or Actos (pioglitazone hydrochloride) for one year. Both Avandia and Actos belong to the same class of diabetes drugs. Both now contain warning labels about using the medications in patients with existing heart failure.

According to CBCNews.Ca, medical claims data for 28,361 patients were reviewed by the research team—14,260 took Actos; 14,101 took Avandia. Avandia patients experienced an increased likelihood of death at a rate of 15 percent and a 13 percent increased risk of heart failure, versus those taking Actos. According to CBCNews.Ca, the Avandia group experienced 1,869 deaths, while only 885 died in the Actos group. Avandia is made by GlaxoSmithKline and Actos is made by Takeda Pharmaceuticals North America In

In May 2007, a New England Journal of Medicine study concluded that Avandia increased the risk of cardiovascular problems in those who took it. U.S. News and World Report noted that the increased risk was at 42 percent and that, based on the study, Avandia might be riskier than Actos.

Both drugs are part of a class of drugs called thiazolidinediones, which are used to lower blood sugar in patients with type 2 diabetes. According to U.S. News and World Report, the U.S. Food and Drug Administration said that GlaxoSmithKline had agreed to add to the existing "black box" an additional warning about the potential increased risk for heart attacks when taking Avandia.

Winkelmayer says that both Actos and Avandia should be used with caution, with extra caution exercised for heart patients, and that neither drug should be prescribed as initial treatment, according to U.S. News and World Report. Dr. Eric J. Topol, director of the Scripps Translational Science Institute and chief academic officer at Scripps Health in La Jolla, California, agrees, “The study reinforces the heart failure risk of rosiglitazone versus pioglitazone," Topol told U.S. News and World Report.

Winkelmayer's study was supported by the American Heart Association and Satellite Healthcare Inc. The researchers also received grants from the pharmaceutical companies Amgen, Fresenius Medical Care, and GlaxoSmithKline/

CBCNews.Ca noted that the American Diabetes Association and a European counterpart dropped Avandia from a list of recommended treatments for people with Type 2 diabetes last month.

Another Study Confirms Avandia, Actos Bone Fracture Risk

Tue, 29 Apr 2008 00:00:00 -0700

Avandia, a diabetes drug already mired in controversy, may double the risk of bone fractures, according to a new study. The study, conducted by Swiss researchers, found a similar risk with the diabetes drug Actos. Previous studies have found that these drugs increase the risk of bone fractures, but the Swiss study sheds light on how serious this problem might be.

Avandia has been a subject of debate since last May, 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. Last July, the Food & Drug Administration (FDA) convened a panel to discuss the issues surrounding Avandia’s heart attack risk. The panel voted 20-3 that the drug did in fact raise the chance of heart attacks, yet the panel still voted 22-1 to allow it to remain on the market. In November, the FDA announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks. However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues. These critics continue to call on both GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market. One diabetes expert, Dr. John Buse, has said that in action on Avandia might be responsible for as many as 83,000 preventable heart attacks.

According to the Swiss bone fracture study, those on Avandia or Actos had double or triple the odds of non-spine fractures. The odds for fracture were increased among patients who took the drugs for approximately 12 to 18 months and the risk was highest for those with two or more years of therapy. The researchers came to their conclusions by comparing the records of 1,020 diabetic patients with fractures diagnosed by British doctors between 1994 and 2005 against a control group of diabetics who did not have fractures.

Avandia and Actos belong to a class of medicines called thiazolidinediones. Last December, researchers in California published a study that explained the possible reasons for the drugs' effects on bone health. In the body, old bone cells are constantly being replaced by newer cells. This process helps to keep bones strong and resistant to fractures. While it was already known that thiazolidinediones inhibited the action of osteoblasts, cells in the body that build bone, the new research found that thiazolidinediones also appears to affect a key cellular protein called the peroxisome proliferator-activated receptor (PPAR-gamma). In their study, the California team discovered that activating this receptor in mice also stimulates the production of osteoclasts, cells whose key function is to degrade bone. Proper bone health is maintained by a balance between osteoclasts and osteoblasts. When this balance is upset, a patient becomes more susceptible to bone fractures, and stands a much higher chance of developing osteoporosis.

With an estimated 3.5 million or more U.S. patients taking thiazolidinediones, the public health impact from bone degradation could be substantial. Based on both the Swiss and California studies, diabetes patients already at a high risk for bone fractures and osteoporosis - for example, post-menopausal women - might want to ask their doctors about alternatives to thiazolidinediones. There are currently many diabetes drugs on the market that do not carry a similar bone fracture and osteoporosis risk.

Avandia Study Says Drug Increases Chance of Heart Failure

Fri, 28 Sep 2007 00:00:00 -0700

Yet another study has found that Avandia and Actos, popular diabetes drugs, raise a patient’s risk for heart failure. These new findings are just the latest to cast doubts on the safety of these medications, which have been under scrutiny for some time.

Actos and Avandia are drugs known as thiazolidinediones, or TZDs and are used to lower blood sugar.   These drugs have been under scrutiny since May when a study of 42 clinical trials conducted by the Cleveland Clinic showed that patients taking Avandia had a 43% higher risk of having a heart attack, and a 64% higher chance of sudden cardiac death. The Cleveland Clinic study also found that Avandia nearly doubled the risk for heart failure. That study caused the Food & Drug Administration (FDA) to convene a hearing of an advisory panel to discuss Avandia’s heart attack risks. While the panel agreed that patients using Avandia do face a greater risk of heart attack, and the diabetes drug should bear the strictest FDA warnings, it stopped short of recommending that Avandia be pulled from the market entirely. Both Actos and Avandia already carry warnings that they may cause or worsen congestive heart failure, a condition in which the heart does not pump blood efficiently.

Published in the Lancet, the latest study was conducted by researchers at the Lahey Medical Center in Massachusetts. Like most other research into these drugs, it was a meta-analysis, meaning that it pooled data from many different clinical trials. This particular study took data from seven trials where more than 20,000 patients with type 2 diabetes or pre diabetes were given Actos or Avandia.   The overall risk of heart failure in all patients was around 72% percent higher than it is the general population.   Patients with a history of heart disease and heart failure had he highest risk of developing heart failure when using Actos or Avandia. However the Lahey study did not find an increased risk of cardiac death in patients using these drugs, something that other research has pointed to.

The authors of the Lahey study claim that the data they examined was more robust than those the Cleveland Clinic analyzed.   The researchers had a panel of experts determine if any heart attacks had occurred in the clinical trials they analyzed.   Also, the seven clinical trials used in the Lahey study had all been previously published.

While the Lahey researchers found that Actos and Avandia both were effective in controlling blood sugar, an accompanying editorial in the Lancet criticized researchers for using reduced blood sugar levels as evidence of a drug’s success.   Rather, it said they should focus more on patient outcomes such as quality of life and survival. The editorial recommends that drug companies conduct further clinical trials of their medications after they are on the market. “Regulatory agencies must hold manufacturers’ feet to the fire to ensure that these are performed,” it says. “Unless limitations on the understanding, analysis, and communication of drug safety issues are addressed, the TZDs will simply become the latest in a series of preventable drug disasters.

Actos Side Effects Heart Disease & Heart Failure Lawsuit

Fri, 28 Sep 2007 00:00:00 -0700

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Injured by Actos?

Actos is a newer class of diabetes drugs called thiazolidinediones or glitazones, which increase the body's sensitivity to insulin. The FDA (Food & Drug Administration) approved Actos on July 15, 1999. Actos is manufactured by Takeda Chemical Industries.

The first approved drug in the class, Rezulin, was taken off the market in 2000 after it was linked to dozens of cases of fatal liver disease. Avandia is another drug that is a thiazolidinediones or glitazones.

The American Heart Association and American Diabetes Association issued recommendations to guide the use of Actos, a glucose-lowering drugs and other as thiazolidinediones (TZDs). Diabetics who have mild heart disease or any problems with their kidneys may be at an increased risk of developing congestive heart failure if they take certain diabetes medications, according to a new study.

The study, published in the September 9, 2003 issue of the Mayo Clinic Proceedings, reported on six cases of congestive heart failure in people taking pioglitazone (Actos) or rosiglitazone (Avandia) to help control their diabetes. The researchers studied the records of six men, between the ages of 66 and 78 years, with type 2 diabetes who had gone to the emergency room at Dallas Veterans Affairs Medical Center emergency room.

All six patients complained of shortness of breath, swelling of their feet, and weight gain, which are symptoms of congestive heart failure and pulmonary edema (fluid buildup in the lungs). Congestive heart failure occurs when the heart can no longer pump enough blood to maintain adequate circulation. Because the heart doesn't pump properly, fluid often builds up in the lungs.

Four of the six people in this study had chronic renal insufficiency, which means that their kidneys weren't functioning normally. Only two had any previous signs of heart disease. Four of the six had high blood pressure. They had been on the diabetes medications for between one month and 16 months. Three people developed symptoms within one to three months after the dose of their diabetes drug had been increased.

If you or a loved one took Actos and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.