(Avandia Heart Attack News) Fri, 30 Jan 2015 22:59:24 -0500 Fri, 30 Jan 2015 22:59:24 -0500 pixel-app en FDA identifies stumbling blocks for new diabetes drug Wed, 09 Jan 2013 00:00:00 -0500 The Food and Drug Administration issued a statement this week indicating that a clinical trial of a new type 2 diabetes drug has suffered some setbacks as there have been a rash of dangerous side effects reported among its participants.

According to a Reuters report, the FDA published a report this week on the developments of a clinical trial on the prospective Johnson & Johnson drug canagliflozin, a proposed new prescription drug treatment in the fight against type 2 diabetes. The agency said early results of a clinical trial of the drug show that increases a person's levels of bad cholesterol to the point where the drug poses heart risks to a patient taking it.

This side effect is bad news for diabetics, who are more often than not overweight or obese and face the greatest risk of diabetes-related death from heart disease. The FDA requires any new type 2 diabetes drug that gets its approval to be free of the risk of causing heart-related complications. This development obviously impedes this drug's progress past the agency and to prescribing physicians.

The agency also noted in its study that patients in the trial had also shown to have suffered adverse effects on their kidneys and increased fungal growth in the perineum and bacterial growth in the urinary tract, according to the report. A final review of the drug is expected on June 10 when FDA officials will vote on the drug's overall safety and whether or not to recommend it for approval.

The indications are that this panel may choose to send the drug back for more development, especially to work on lowering the risk of heart-related side effects or to at least identify certain patients who may be more at risk of suffering heart-related problems while taking canagliflozin. Testing during the trial to find out if taking the drug increased the risk of cancer of the kidneys, adrenal glands, testes, breasts, and bladder were negative.

If Johnson & Johnson is successful in getting canagliflozin approved for use, the company plans to market it as Invokana. 

If it is approved, it will join other drugs in a class known as SGLT2 inhibitors, a newer treatment of type 2 diabetes, a disease that is growing at a rate to be considered a public health epidemic. Millions of Americans have been diagnosed with type 2 diabetes and the disease figures to affect more Americans in the future as lifestyles become more sedentary and diets become more unhealthy.

Current and previous drug treatments for type 2 diabetes have only enjoyed moderate levels of success but many people taking them have suffered serious and sometimes fatal side effects of the drug.

Glaxo Reaches Record $3 Billion Settlement to Resolve Paxil, Wellbutrin and Avandia Fraud Charges Tue, 03 Jul 2012 00:00:00 -0400 GlaxoSmithKline has agreed to pay a record settlement to resolve charges that it illegally marketed some of its drugs, including Paxil and Wellbutrin.  The $3 billion settlement with the U. S. Justice Department will also resolve charges that Glaxo failed to report important safety data to the U.S. Food & Drug Administration (FDA) about its diabetes drug Avandia.

According to the Justice Department, the $3 billion Glaxo settlement constitutes the largest healthcare-fraud settlement in U.S. history.

"Today's multibillion-dollar settlement is unprecedented in both scope and size. It underscores this administration's firm commitment to protecting the American people and holding accountable those who commit healthcare fraud," James Cole, U.S. deputy attorney general, said at a news conference in Washington, D.C.

According to a statement from the Justice Department, Glaxo agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia.  Under the terms of the plea agreement, the company will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.  The guilty plea and penalties must still be approved by the U.S. District Court. 

Glaxo has also agreed to pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states.   The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations, the Justice Department said.

The government had charged that Glaxo marketed Paxil to patients under 18, even though the FDA had not approved Paxil for use in children.  It further charged that the company promoted off-label uses of Wellbutrin, including for weight-loss and for the treatment of sexual dysfunction and substance abuse addictions.  According to the government, Glaxo paid doctors millions of dollars to promote these unapproved uses of Wellbutrin.

According to a report published by The Los Angeles Times, this is just the latest in a string of large settlements the Justice Department has reached with big pharmaceutical companies for illegally marketing their drugs.  In 2009, Pfizer plead guilty and agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs, including its now-recalled painkiller, Bextra; the anti-psychotic Geodon; and its anti-epileptic, Lyrica.  In 2009, Eli Lilly & Co. also agreed to pleaded guilty to a federal misdemeanor charge and pay $1.42 billion for unapproved uses of its schizophrenia drug Zyprexa.

Diabetic Macular Edema a Possible Avandia, Actos Side Effect Tue, 12 Jun 2012 00:00:00 -0400 A new study is raising more concerns about the possible side effects of thiazolidinediones, a group of drugs that includes Actos and Avandia.   The study, published in the Archives of Internal Medicine, found that type 2 diabetes who took either Actos or Avandia faced a higher risk of developing an eye disorder called macular edema compared to patients who did not take the drugs.

The study followed more than 100,000 people for a decade with type 2 diabetes who were listed in a U.K. database.  None of the patients had macular edema at the start of the study.  Just over 3,200 were using either Actos or Avandia. 

After one year, 1.3 percent of patients taking thiazolidinedione developed diabetic macular edema, compared with 0.2 percent of those not taking the drugs. The risk stayed the same whether patients were taking either Avandia or Actos.  When either drug was used with insulin, the risk increased to 4.4-fold.

The Archives of Internal Medicine study is the largest to ever investigate a possible connection between Actos or Avandia and macular edema. 

"Clinicians should be vigilant in the clinical screening for diabetic macular edema among those patients taking thiazolidinediones," the study authors wrote.

They advised that type 2 diabetics treated with Actos or Avandia have their vision checked on a regular basis, especially if they are using insulin or have pre-existing vision problems.   The study authors also called for additional studies to determine if thiazolidnenones cause diabetic macular edema.

Settlements Reported in 20,000 Avandia Heart Attack Lawwsuits Thu, 02 Feb 2012 00:00:00 -0500 GlaxoSmithKline has reportedly agreed to settle more than 20,000 Avandia heart attack lawsuits, according to a report from Bloomberg News.  The agreement to settle the Avandia lawsuits was reached in court-ordered mediation and comes just months after Glaxo said it would pay $3 billion to settle U.S. criminal and civil probes into whether it illegally marketed Avandia and other medications. 

Since November 2007, Avandia's U.S. label has included a black box warning detailing its association with heart attacks. The black box was added after Dr. Steven Nissen of the Cleveland Clinic published a study showing that patients taking Avandia had a 40 percent increase in the risk of cardiovascular disease. Since 2007, more evidence of Avandia's heart risks has accumulated. Last year, the U.S. Food & Drug Administration (FDA) placed severe restrictions on sales of Avandia, after determining its heart risks outweighed its benefits.

The controversy surrounding Avandia sparked thousands of product liability lawsuits.  Previously, Glaxo had agreed to pay over $700 million to settle over 15,000 patient claims that Avandia caused heart attacks and strokes.  In November, U.S. District Judge Cynthia Rufe appointed a mediator to preside over settlement negotiations for an unspecified number of Avandia cases that were consolidated before her in Philadelphia, and imposed a deadline for settling 75 percent of cases.  More than 2,500 cases are pending before Judge Rufe, Bloomberg said, while others have been filed in state courts around the country.

Now, a plaintiffs' attorney involved in that litigation has told Bloomberg that Glaxo has reached an agreement to settle 20,000 Avandia lawsuits.  However, it is still unclear if enough cases have been settled to meet the deadline.  If Judge Rufe's directive isn't been met by the deadline, she's promised to start scheduling cases for trial.

In a statement emailed to Bloomberg yesterday, a Glaxo spokesperson said the most-recent settlements of Avandia patients’ suits “are covered by existing provisions and those payments will be funded through existing cash resources.”

Avandia, Actos Study Sees Higher Risk of Diabetic Macular Edema Tue, 28 Jun 2011 00:00:00 -0400 People taking the diabetes medications Actos or Avandia have yet another side effect to worry about - a potentially blinding eye disorder called diabetic macular edema.  Diabetics are already vulnerable for this disease, which causes damage to retinal capillaries; however, their risk can usually be reduced by keeping blood sugar levels under control.

A new study involving 100,000 diabetics in the U.K. has found that people taking either Actos or Avandia who are unable to control their blood sugar are at an increased risk of the eye disease.  The study found that 1.3 percent of those who took either Actos or Avandia developed diabetic macular edema after one year, compared to 0.2 percent of those who did not take either of the drugs. Overall, the risk of diabetic macular edema increased 3 to 6 times among people who used Actos or Avandia.

The new study, conducted by researchers from the University of Nottingham, was presented over the weekend at the American Diabetes Association’s Annual Meeting in San Diego. 

Earlier this month, sales of Actos were suspended in France and Germany after a French study found that people taking Actos for more than a year faced a higher risk of developing bladder cancer.  Shortly after that, the U.S. Food & Drug Administration (FDA) issued a Drug Safety Communication to alert the public to the Actos bladder cancer association, and mandated that information regarding this potential side effect be added to the Actos label.

Avandia’s label has included a black box warning regarding an increased heart attack risk since 2007. Last year, the FDA placed severe restrictions on the sale of Avandia because of its association with an increased risk of heart attacks and strokes.

1,000 Avandia Settlements in the Works Thu, 05 May 2011 00:00:00 -0400 Momentum appears to be building towards more Avandia lawsuit settlements.  Bloomberg News is reporting that GlaxoSmithKline, maker of the controversial diabetes drug, is close to resolving about 1,000 Avandia lawsuits now pending in state courts.

During a hearing in the Philadelphia federal court where 1,600 Avandia lawsuits have been consolidated, a plaintiff’s attorney told the judge overseeing those cases that settlement talks in Los Angeles state court have resolved about 2,400 cases, while 200 in Philadelphia state court and an undetermined number of cases in Illinois are close to settlement. 

There are currently around 5,300 Avandia lawsuits  pending in state courts around the country, Bloomberg said.  The lawsuits claim Glaxo failed to adequately warn Avandia users about its association with heart attacks and strokes.

According to Bloomberg, Glaxo has spent at least $700 million over the last eight months to resolve about 12,000 Avandia lawsuits.  The drugmaker has set aside more than $6 billion for legal costs tied to Avandia and other medications

Several Avandia lawsuits are set to go to trial in the next year, Bloomberg said.  Those include two in November in California  and New Mexico, and another in New Mexico scheduled for March 2012.

According to a report from, Avandia’s heart risks have been known since November 2007, when a black box warning – the U.S. Food & Drug Administration’s (FDA) strongest safety alert – detailing its association with myocardial ischemia was added to its label. Then last September, the FDA restricted sales of Avandia, as well Avandamet and Avandaryl, after concluding their association with an increased risk of heart attacks and strokes outweighed the drugs’ benefits for most patients. At the same time, regulators in Europe announced that sales of Avandia and related drugs would be suspended.

After U.S. and European regulators took those actions, Glaxo stopped promoting Avandia.  According to Bloomberg, since those restrictions were imposed, sales of Avandia - once the world's best selling diabetes drug – have fallen 43 percent.

Avandia Side Effects Lawsuits | Side Effects: Heart Attack, Stroke, Heart Failure, Heart Complication Thu, 05 May 2011 00:00:00 -0400 Avandia Side Effects May Lead To Heart Attack Lawsuits

Avandia Side Effects | Lawsuits, Lawyers | Side Effects: Heart Attack, Stroke, Heart Failure, Heart Complications

Avandia, a drug used to treat type 2 diabetes, has been linked to a significant risk of heart attack, strokes and heart failure. In 2010, the US Food & Drug Administration (FDA) severely restricted sales of Avandia. Avandia has also been restricted in Canada, and Avandia sales have been suspended in Europe. Our Avandia injury lawyers believe that people injured by this diabetes drug may be entitled to receive compensation from GlaxoSmithKline in an Avandia lawsuit.

If you or a loved one took Avandia and suffered from a heart attack, stroke or other heart problem, our Avandia injury lawyers want to hear from you today. You may be entitled to receive compensation for medical bills, lost wages, pain and suffering, and other damages. Please contact on of our Avandia injury lawyers today for a free Avandia lawsuit evaluation.

Avandia's Sorry History

Avandia is an anti-diabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin. Known generically as rosiglitazone, it is marketed as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl).

Avandia was once one of the best-selling diabetes drugs on the market. In 2006, sales peaked at $2.5 billion dollars. But in 2007, doctors began to back away from Avandia after it was linked to a high risk of heart attack, stroke and other heart problems.

Since November 2007, Avandia's label has included a black box warning the FDA's strongest safety alert detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since 2007, evidence of Avandia's heart risks has continued to grow. In the summer of 2010, the FDA convened an outside advisory panel to consider Avandia once again. The panel voted 20-12 to recommend that Avandia be allowed to stay on the market. However, 10 panel members voted that its sales should be restricted and that warnings on its label regarding heart risks be strengthened.

Among the evidence considered by the advisory panel was a study conducted by Dr. David Graham of the FDA’s Center for Drug Evaluation and Research. It found that patients in the US Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009. Graham's study involved 227,500 patients, making it the largest to date, and found that patients who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took another drug called Actos.

In September 2010, the FDA placed severe restrictions on Avandia, citing its heart risks. The FDA's directive means that patients in the US will only have access to Avandia if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of Avandia's cardiac side effects. The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks, FDA Commissioner Margaret A. Hamburg, M.D. said in a statement announcing the new Avandia restrictions. We are seeking to strike the right balance to support clinical care.

At the same time, regulators in Europe announced that sales of Avandia and related drugs would be suspended. The suspension is to remain in place unless convincing data are provided that identify a group of patients that would benefit from the drugs. In November 2010, the Canadian regulatory agency Health Canada announced restrictions on Avandia similar to those in the US.

In addition to restricting Avandia sales, the FDA also ordered Glaxo to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, another study considered by the advisory panel. RECORD studied the cardiovascular safety of Avandia compared to standard diabetes drugs. RECORD, which was released in 2009, did not find increased heart risks, as other Avandia studies have. It was touted by Glaxo as evidence of the drug's safety.

However, RECORD was widely criticized on many fronts. Prior to the 2010 advisory panel meeting, the FDA posted an Avandia briefing document on its Web site that characterized RECORD as inadequately designed and conducted to provide any reassurance about the CV (cardiovascular safety) of rosiglitazone. The memo further stated that the RECORD results confirm and extend the recognized concerns regarding heart failure” and possibly suggest an increased risk for heart attacks. The FDA review of RECORD found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial tally of adverse events, mistakes that further obscured Avandia's heart risks.

Finally, the FDA halted a Glaxo-funded clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial was designed to compare Avandia to Actos and to standard diabetes drugs.

FDA Restricts Sales of Avandia

In September 2010, the Food & Drug Administration (FDA) placed severe restrictions on Avandia, citing its heart risks. The FDA's directive means that patients in the US will only have access to Avandia if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of Avandia's cardiac side effects.

Legal Help for Victims of Avandia Injuries

It is important that Glaxo be held accountable for the injuries Avandia has caused. If you or someone you care about suffered an Avandia heart attack or stroke, you have valuable legal rights. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-529-4363) to discuss your case with one of our Avandia injury lawyers today.