Two North Carolina patients have sued GlaxoSmithKline claiming its diabetes drug, Avandia, caused their heart attacks.  Hundreds more are seeking compensation for health problems they experienced after taking Avandia.  The patients blame Glaxo for not adequately warning of all of the pill’s cardiovascular risks.

Glaxo “knew of these dangerous effects in Avandia from the many trials which they performed and to which they had access and from their own analysis of these studies,” the lawsuit reads. “But [the company] took no action to adequately warn or remedy the defects, but instead concealed, suppressed and failed to disclose these dangers.”  The lawsuit also claims that doctors and patients didn’t have the information they needed to assess Avandia’s risks and that Glaxo sales representatives minimized Avandia’s side effects.  Also according to the lawsuit, one patient involved took Avandia from April 2006 until she was admitted to the hospital because of a heart attack in February 2007; she has since developed congestive heart failure.  The other patient took Avandia from 2000 to 2007; in 2002 she suffered a heart attack and required triple bypass surgery. (more…)

Last week, a Food & Drug Administration (FDA) advisory panel voted to back tougher testing requirements for diabetes drugs.  In a 14-2 vote, which came late last Wednesday at the end of 2-day meeting, the outside experts recommended that diabetes drugs undergo more thorough safety reviews to ensure they don’t raise the risk of heart problems.  The panel also recommended that after approval, the makers of diabetes drugs conduct long-term studies to assess heart risks, even if initial clinical trials have not turned up such issues.

The FDA decided to take a look at diabetes drug testing after one popular medication - Avandia - was linked to an increased risk of heart attacks.  Currently, the FDA requires the makers of diabetes drugs to prove they lower blood sugar levels.  This outcome is known as a surrogate endpoint, because it was thought that lowering blood sugar would have a positive effect on cardiac risks and life span - the true goals of a diabetes drug.  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. (more…)

A prominent cardiologist told federal regulators yesterday that new diabetes drugs should be tested to insure that they don’t cause heart problems. Dr. Stephen Nissan, the lead researcher on a study that found Avandia increased heart attack risks,  told a Food & Drug Administration (FDA) panel considering new rules for the drugs that it is high-time the agency toughened requirements for new diabetes drugs.

Currently, the FDA only requires that the makers of new diabetes drugs to prove that they lower blood sugar levels before they are approved. But Dr. Nissen told the FDA panel that there are enough drugs on themarket now that lower blood sugar very well. (more…)

When doctors were recently asked which commonly prescribed medications they would avoid, they came up with the following eight.  Perhaps you might want to reconsider these medications as well.  At a minimum, speak to your doctor, as there are safer options for all of these medications.

• Advair:  This asthma medication contains the long-acting beta-agonist (LABA) salmeterol.  A 2006 study of 19 trials, which was published in the Annals of Internal Medicine, revealed that with regular use, LABAs can increase asthma attack severity.  Salmeterol is more widely prescribed than other LABAs, thus the danger is greater and may contribute to as many as 5,000 asthma-related deaths in the United States annually.  Another study that same year led the US Food and Drug Administration (FDA) to label Advair with a “black box,” the FDA’s strongest warning.   (more…)

According to researchers comparing the results of two diabetes trials, weight gain, the use of multiple drug combinations, and even lowering blood sugar too low, too fast may have been factors in causing early deaths.  Both trials, one conducted in the United States and Canada, the other in Australia, were designed to measure the benefits of using drugs such as Avandia to dramatically lower blood sugar in diabetes patients.

The two trials followed over 21,000 elderly, often obese, diabetics, using multiple drugs—including Avandia—to tightly control blood sugar levels in an effort to avoid complications that can cause disability and death.  While cutting kidney disease in one trial, the treatments—which included Avandia—failed to protect diabetics from heart disease and stroke in the second.
 Avandia was given to 90 percent of the intensive therapy group in the second—Accord—trial.  Both studies, the largest ever for diabetes, were just published by the New England Journal of Medicine. (more…)

Outgoing head of GlaxoSmithKline (GSK) Jean-Pierre Garnier says the he does not foresee the US Food and Drug Administration (FDA) softening its position on drug approvals.  Garnier is stepping down at the company’s annual meeting next week. “This is not a pendulum,” he says, “society wants to avoid risk.  We have to tease out rare side effects earlier.”

Garnier added that the FDA has raised the bar and companies must adapt by shifting drug development priorities and conducting trials on targeted sub-populations to better realize rare side effects prior to regulatory submission.  Other senior industry personnel suggest the U.S. election has strongly impacted the FDA’s position on new drugs and Garnier believes “the market will get reconstituted” with a new focus on so-called “progressive blockbusters,” which will ultimately reduce drug development costs by eliminating false negative results sooner. (more…)

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. (more…)

Avandia and Vytorin are the subject of yet another government investigation.  The Government Accountability Office (GAO) will look into whether the US Food and Drug Administration’s (FDA) drug-review process cleared two popular medications without sufficient proof of their safety or effectiveness.

Senator Charles E. Grassley (Republican-Iowa) requested the GAO investigation after recent studies suggested that the diabetes pill Avandia increases the risk of cardiac problems in patients, and another study showed that  the cholesterol drug Vytorin may not actually lower the risk of heart attack and artery-clogging plaque, as assumed by millions of patients and doctors.  “There’s enough of a pattern of problematic drugs to ask for an independent review of how the FDA follows up on the effects of medicines that it’s approved,” Grassley said.  The question is whether the FDA should approve drugs based on biological measures, such as cholesterol and blood sugar, without evidence that they improve more meaningful measures, such as survival. (more…)

Avandia lawsuits against GlaxoSmithKline over the drug’s alleged cardiac side effects are beginning to make their way through the courts,  and many more are expected.  One a man is suing GlaxoSmithKline in federal court, claiming Avandia caused him to undergo heart bypass surgery.  Attorneys allege the drug maker should have known that Avandia—prescribed to improve blood sugar in type 2 diabetes patients—is linked to a significant and increased risk of heart failure, heart attack, and stroke.

The lawsuit is among several filed nationwide targeting Avandia and Glaxo; it is believed there are thousands yet to be filed.  Over six million Americans used the drug and concern about Avandia is nothing new.  The connection between Avandia and increased heart failure risk has been known since 1999 when the drug was first approved.   Avandia sales have plummeted since publication in The New England Journal of Medicine linking Avandia with increased risk of heart attack and failure, but Nancy Pekarek, spokeswoman for GlaxoSmithKline, said the company stands by Avandia, “We are certainly confident that when the courts or the juries look at the clinical data, the responsible way in which we communicated that information, and our openness in posting our clinical trial data online, they will see our position,” she said.  The lawsuit alleges that the company “had the knowledge, the means, and the duty to provide the medical community and the consuming public with more accurate descriptive information and more adequate warnings regarding the association between Avandia and heart failure…” (more…)

A diabetes drug trial was halted recently after it was determined that trial participants receiving aggressive diabetes treatment were dying at a higher rate than those who did not receive intensive therapy.  However, researchers involved in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial were quick to assert that the controversial drug Avandia was not to blame for the deaths, and that the overly aggressive treatment administered to some participants was most likely the cause of the deaths.

The ACCORD trial, sponsored by the U.S. National Heart, Lung, and Blood Institute (NHLBI), began in 2001 at 77 sites in the United States and Canada with the enrollment of 10,251 patients with type 2 diabetes who were at high risk for heart attack or stroke because they had at least two risk factors, including high blood pressure, high cholesterol or obesity. Those in the trial received either medications to aggressively lower their blood sugar below recommended levels, or standard treatment to control their disease.  The goal of the aggressive treatment group was to lower blood sugar levels — a measure known as hemoglobin A1c — to below 6 percent, far below the current target of under 7 percent and closer to what is seen in non-diabetics. The researchers said they would now adjust the ACCORD trial so the blood sugar of patients would not be lowered so much. (more…)