Avandia: June 2007 Archives

Warning to Avandia Patients in Canada

Avandia patients in Canada are being advised to speak to their doctors after a study published in the New England Journal of Medicine established a link between the risk of heart-related problems and Avandia. Prior to the study, the U.S. Food and Drug Administration added a black box warning about heart-related problems to Avandia; this is the most severe warning possible.

Warning to Avandia Patients in Canada

Lawsuits against GlaxoSmithKline, the manufacturer of Avandia, already have begun in the United States. Those who are taking Avandia for treatment of diabetes should not stop taking the drug without first consulting a doctor.

Posted by Patricia Bowling at 01:58 PM | Permalink

GlaxoSmithKline Sued in Death of Man

Larry Alan Stanford died on May 21, the same day that the report implicating Avandia for increasing heart attack risk in those who took it was published. Stanford's family is suing Glaxo, alleging that the company knew the risks of the drug, yet continued to sell it anyway.

GlaxoSmithkline Sued in Death of Man Who Took Avandia

A New York law firm already has filed a class action shareholder lawsuit against Glaxo. Glaxo maintains that Avandia is a safe treatment for diabetes and that the New England Journal study was flawed.

Posted by Patricia Bowling at 01:50 PM | Permalink

Link Between Avandia and Canadian Deaths Explored

Health Canada says that 19 people died from heart-related problems while taking Avandia. There is not enough information in 12 of the deaths to decide whether or not Avandia caused the death; however, in six of the cases, there is a chance that Avandia caused the death. A recent medical review suggests that people who took Avandia had a 43 percent higher chance of having a heart attack.

Link Between Avandia and Canadian Deaths Explored

Avandia is made by GlaxoSmithKline and was approved for use in Canada in March 2000. In 2001, Glaxo warned that Avandia can cause fluid retention that can cause congestive heart failure. Those who have experienced acute heart failure, liver disease, or shortness of breath should ask their doctors if they should continue to take Avandia.

Posted by Patricia Bowling at 10:04 PM | Permalink

Perlegen Seeking Genes Responsible for Side Effects

Perlegen Sciences announced that it has collected over 3,000 DNA samples from diabetic patients who were treated with Actos and Avandia. The company plans to analyze the samples to determine the genetic variability that makes patients susceptible to side effects. About 200 million people worldwide have diabetes. Both Actos and Avandia are drugs of the insulin sensitizing thiazolinedione class.

Perlegen Seeking Genes Responsible for Actos and Avandia Side-Effects; Completed Collection of 3,000 DNA Samples

The US Food and Drug Administration has asked that "black box" labels be added to the packaging of the drugs. Perlegen is a leader in identifying the genetic variation that is linked to drug response and predisposition to disease. Perlegen will use these samples to identify genetic variation that contribute to the risk of experiencing the side effects of taking a certain drug.

Posted by Patricia Bowling at 09:14 PM | Permalink

Avandia Hearing Says FDA is Negligent

IMS Health, a medical information tracking firm, says that the FDA was negligent in monitoring the diabetes drug Avandia for health risks. The New England Journal of Medicine says that there was a 43 percent increase in the risk of heart attack in Avandia patients. Dr. Steven Nissen and Kathy Wolski conducted the meta-analysis of previous data.

Avandia Hearing Exposes FDA as Negligent Watchdog

Bart Stupack, the Chairman of the US House Energy and Commerce Committee, said that the concerns over Avandia, only add to the evidence that the U.S. FDA is not doing an adequate job of monitoring products. "The FDA is on notice that we have reached the end of our rope on their stonewalling of investigations into their failures to keep Americans safe from dangerous drugs and poisonous foods," said Stupak.

Posted by Patricia Bowling at 08:59 PM | Permalink

FDA May Lack Speed in Prescription Drug Reviews

Concerns linger over whether the Food and Drug Administration adequately balances speed and safety in approving new drugs. The FDA says that "immediate access to breakthrough medicines" is important to patients, they "also want to believe the drugs are safe."

FDA Might Lack Balance Between Speed, Safety In Prescription Drug Reviews

However, an "increasing number of FDA drug safety officers... say they have been punished or ignored after uncovering dangers of popular medicines." In 1992, the FDA began to accept user fees from drug companies in exchange for faster reviews of medications and any reviewers say that this negatively affected the FDA's authority. The "culture at the FDA shifted toward valuing speed over safety" and the agency managers now "are largely judged on how quickly their employees make a decision on new drug applications."

Posted by Patricia Bowling at 11:16 AM | Permalink

Diabetics Find Alternatives in Wake of Avandia Scare

Many wary patients and doctors are switching diabetes drugs after Avandia was linked to higher heart attack risk. Januvia, a Merck drug that competes against Avandia in the diabetic drug market, has benefited greatly from Avandia's problems. However, Januvia has been on the market an even shorter period than Avandia; risks posed by Januvia may just not be recognized yet.

Amid Avandia Doubts, Diabetics Consider Alternatives

James A. Underberg, who helped test Januvia and is an assistant professor at the New York University School of Medicine, says: "Does Januvia have an effect on cardiovascular? I have no idea," he said this week. "Doctors have to be concerned about the safety of any new drug." Known side effects of Januvia include nasal inflammation, but Merck says that "these events are, for the most part, transient." Many experts still question why patients are being prescribed newer drugs with questionable side effects when proven choices such as metformin and insulin are available.

Posted by Patricia Bowling at 10:58 AM | Permalink

GlaxoSmithKline Sued by Shareholder

GlaxoSmithKline has been sued by shareholders who say the company misled investors about the safety of their drug Avandia. The lawsuit was filed in New York and says that GlaxoSmithKline did not disclose an analysis that showed that Avandia patients face an increased risk of heart attacks. Jean-Pierre Garnier, the Chief Executive Officer of Glaxo, maintains that Avandia isn't dangerous.

GlaxoSmithKline Sued by Shareholder Over Avandia

Glaxo says that their own clinical trials do not show an increased risk of heart conditions in patients taking Avandia. The lawsuit seeks class action status and an unspecified amount in damages for investors who bought GlaxoSmithLine stock between October 27, 2005 and May 21, 2007. Lawyers for Glaxo did not immediately respond to the allegations.

Posted by Patricia Bowling at 10:57 AM | Permalink

Lawsuit Overshadows Glaxo's Launch of New Diet Pill

GlaxoSmithKline is launching a new over-the-counter diet pill. The pill is known as Alli, and it will be the first prescription weight-control drug that will be switched to over-the-counter sales. It will be the only such drug to have won Food and Drug Administration approval and will go on sale in the United States next week.

Lawsuit Over Avandia Overshadows Glaxo's Launch of New Diet Pill

The release of the drug have been overshadowed by the news that Glaxo is facing a lawsuit from U.S. investors who say that the drugmaker misled shareholders about the safety of Avandia; the complaint says that Glaxo "failed to adequately disclose the fact that it had performed a meta-analysis - a pooled analysis of several clinical trials - of Avandia which showed an increased risk of heart attacks". Sales and prescriptions have been falling since the lawsuit was filed.

Posted by Patricia Bowling at 10:55 AM | Permalink

Avandia Market Falls on Safety Concerns

The U.S. market value of GlaxoSmithKline's drug Avandia continues to fall after a report linked the drug to higher rates of heart attacks. Avandia is one of the company's biggest sellers. It is a type of diabetes drug in the thiazolidinedione (TZD) class of drugs.

Avandia's Market Shrinks on Safety Concerns

The recent study was done by Steven Nissen, the head of cardiology at the Cleveland Clinic. It looked at data from 42 trials involving 28,000 patients. Prior to the report, Avandia and Avandament, another GlaxoKlineSmith drug similar to Avandia, had a 53.8 percent share of weekly new drug prescriptions.

Posted by Patricia Bowling at 10:54 AM | Permalink

Rosiglitazone and Cardiotoxicity — Weighing the Evidence

David M. Nathan, M.D., explores the data on the health risks of Rosiglitazone, also known as Avandia, in his editorial entitled Rosiglitazone and Cardiotoxicity — Weighing the Evidence. Nathan says that the recent meta-analysis by Nissen and Wolski that first indicated a potential link between Avandia and death from cardiovascular causes has caused a dilemma for doctors and their patients. If Avandia is determined to be unsafe, millions of patients currently being treated with Avandia will have to be switched to different drugs. However, thus far, does enough evidence exist to merit such action?

Rosiglitazone and Cardiotoxicity — Weighing the Evidence

Nathan says that he feels the unscheduled interim analysis from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes was biased toward Glaxo's own interests. The data from the RECORD trial do not assure the safety of rosiglitazone, but do not suggest that it is unsafe either.

Nathan suggests that patients taking Avandia remember that other medications are available. Nine classes of antidiabetic medications exist, including older medications that are efficient at lowering glycated hemoglobin levels and are less expensive than thiazolidinediones. Nathan wonders if physicians should feel comfortable prescribing a drug that has been linked to increased heart risk by eight percent.

Posted by Patricia Bowling at 11:20 AM | Permalink

Avandia's Safety Defended by Glaxo

Moncef Slaoui, Glaxo's chairman for research and development, testified before the U.S. House Committee on Oversight and Government Reform that Avandia carries no higher cardiac risk than other diabetes medications in its class. Avandia is a type of drug known as a thiazolidinedione, or TDZ. Slaoui acknowledged that TDZ drugs are associated with a higher risk of congestive heart failure; a warning about this already is present on Avandia's label.

Glaxo Defends Avandia's Safety Before Congress

"The most important message today for the Committee and the public is this: The cardiovascular profile of Avandia is comparable to that of the two other oral anti-diabetes medicines that are most widely used in the United States today," said Slaoui. Avandia is used to control blood sugar levels in people with type 2 diabetes whose bodies no longer can regulate insulin.

Posted by Patricia Bowling at 11:43 AM | Permalink

Doctor Says Glaxo Pressured Him to Hush Criticism

John Buse, a diabetes expert from the University of North Carolina, says that he was pressured by GlaxoSmithKline to stop criticizing the safety of Avandia when the drug came on the market in 1999. Buse says that he mentioned his concerns about the safety of the drug to Avandia and was told that his "actions were scurrilous enough to attempt to hold him liable for a loss in market capitalization."

Doctor Says Pressured to Stop Criticism of Glaxo Drug

Buse's testimony was laid before a Food and Drug Administration committee that is debating the safety of the drug. Henry Waxman, the chairman of the committee, says that the recent cases of unsafe products making made available highlights the inadequacy of the FDA's approval process. He said, "Avandia is a case study of the need for reform of our drug safety laws." Glaxo maintains that no real evidence shows extreme cardiac risk linked to Avandia.

Posted by Patricia Bowling at 12:28 PM | Permalink

Information about the RECORD Study

The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes study, or RECORD, was a 6-year, open-label study in which patients with type 2 diabetes who did not have proper glucose control were randomly assigned to take rosiglitazone (Avandia) or a combination of metformin and sulfonylurea. Interim results of the study were collected for 4447 patients after a mean time of 3.75 years in March 2007. Data showed Rosiglitazone was linked to a small, insignificant increase in the risk of the primary outcome.

The Record on Rosiglitazone and the Risk of Myocardial Infarction

However, the study does have several weaknesses. Randomization was not hidden. Also, the primary outcome, which is a compilation of all hospitalizations and deaths from cardiovascular causes is a poor choice for noninferiority design. Lastly, using a composite outcome to design a trial generally leads to less data and low power for any composite-outcome elements that may be of interest.

Posted by Patricia Bowling at 11:39 AM | Permalink

Questions Remain About Rosiglitazone Safety

Jeffrey M. Drazen, M.D., Stephen Morrissey, Ph.D., and Gregory D. Curfman, M.D. responded via editorial in the New England Journal of Medicine to the charges that Avandia increases cardiovascular risk. They say that the New England Journal of Medicine published the study because data suggested enough of a significant risk to justify concern and any increase in cardiovascular risk should be of note.

Rosiglitazone- Continued Uncertainty about Safety

As a result of the publication of the original article, the steering committee of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes began an unplanned interim analysis of some of the cardiovascular end points in the trial. However, the data from the interim analysis are inconclusive because of low statistical power. Much debate still remains about whether Avandia really is a dangerous drug.

Posted by Patricia Bowling at 10:54 AM | Permalink

Rosiglitazone Evaluated for Cardiovascular Outcomes — An Interim Analysis

A study published in the New England Journal of Medicine found that there were more patients with heart failure in the group taking rosglitazone, also known as Avandia, than in the control group. Researchers conclude that their data are inconclusive about any increased risk of hospitalization or death in those who take Avandia. Their data show no evidence to conclude any increased risk of death from cardiovascular causes or any other cause.

Rosiglitazone Evaluated for Cardiovascular Outcomes — An Interim Analysis

The study was performed by Philip D. Home, D.M., D.Phil., Stuart J. Pocock, Ph.D., Henning Beck-Nielsen, D.M.S.C., Ramón Gomis, M.D., Ph.D., Markolf Hanefeld, M.D., Ph.D., Nigel P. Jones, M.A., Michel Komajda, M.D., John J.V. McMurray, M.D., for the RECORD Study Group. It was a meta-analysis that looked at whether there was an increased risk of cardiovascular disease in those with type 2 diabetes taking the diabetes drug Rosiglitazone, or Avandia.

Posted by Patricia Bowling at 10:26 AM | Permalink

New Data Suggests Avandia Does Not Show Health Risks

An ongoing study sponsored by GlaxoSmithKline does not show any increase in the risk of heart attacks in patients taking the diabetes drug Avandia. However, the interim data does show that two times as many patients taking Avandia had congestive heart failure. Glaxo says that the increased risk for congestive failure already had been recognized.

Glaxo Says Avandia Data Comforts, Experts Unsure

Moncef Slaoui, Glaxo's research and development chairman, says that "patients and physicians should find these date reassuring." However, Dr. Bruce Psaty, from the University of Washington in Seattle, says that a 33 percent higher risk of heart attack in Avandia users is well supported by research: "Rosiglitazone ... appears to be associated with an increase rather than a decrease in the risk of myocardial infarction (heart attack)."

Posted by Patricia Bowling at 12:32 AM | Permalink

Avandia Fiasco Questions U.S. Drug Approval System

The recent report on Avandia that links the drug to an increased heart attack risk is reigniting concerns that the Food and Drug Administration is not stringent enough in its monitoring system of new drugs. The Food and Drug Administration had previously been criticized for not doing more once Merck & Co.'s Vioxx painkiller was linked to heart dangers. Representative Henry Waxman, said "The American people deserve to know why eight years after FDA approved Avandia, it's still unclear whether the drug is harmful or helpful."

Glaxo's Avandia Fuels Arguments for Tougher U.S. Drug Oversight

Glaxo has responded to the allegations that Avandia is unsafe by saying that the evidence is incomplete and inconclusive. Ron Krall, Glaxo's chief medical officer, says that the company's research has not shown any evidence of increased risk.

Posted by Patricia Bowling at 12:47 AM | Permalink

June 29, 2007

Warning to Avandia Patients in Canada

June 28, 2007

GlaxoSmithKline Sued in Death of Man

June 27, 2007

Link Between Avandia and Canadian Deaths Explored

June 26, 2007

Perlegen Seeking Genes Responsible for Side Effects

June 25, 2007

Avandia Hearing Says FDA is Negligent

June 22, 2007

FDA May Lack Speed in Prescription Drug Reviews

June 21, 2007

Diabetics Find Alternatives in Wake of Avandia Scare

June 20, 2007

GlaxoSmithKline Sued by Shareholder

June 19, 2007

Lawsuit Overshadows Glaxo's Launch of New Diet Pill

June 18, 2007

Avandia Market Falls on Safety Concerns

June 15, 2007

Rosiglitazone and Cardiotoxicity — Weighing the Evidence

June 11, 2007

Avandia's Safety Defended by Glaxo

June 06, 2007

Doctor Says Glaxo Pressured Him to Hush Criticism

Information about the RECORD Study

Questions Remain About Rosiglitazone Safety

Rosiglitazone Evaluated for Cardiovascular Outcomes — An Interim Analysis

New Data Suggests Avandia Does Not Show Health Risks

June 05, 2007

Avandia Fiasco Questions U.S. Drug Approval System