Breaking news: The federal Food and Drug Administration (FDA) has ordered GlaxoSmithKline, the makers of controversial diabetes medication Avandia (rosiglitazone), to stop enrolling patients in its head-to-head comparator trial with Actos (poglitazone). Many think this decision is a prelude to the FDA withdrawing the drug.
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Latest Avandia News:
A federal medical advisory panel recommended Wednesday that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.
The panel members also voiced great skepticism about the company’s trustworthiness after questions were raised about its clinical trials. And internal company documents showed that the company for years kept crucial safety information about Avandia from the public.
Read full article at New York Times: “F.D.A. Panel Votes to Restrict Avandia”
New York Times: “Avandia Panel Hints at Doubts Over Credibility”
New York Times: “Diabetes Drug Maker Hid Test Data, Files Indicate”
GlaxoSmithKline misleads FDA about the dangers of Avandia in its Record study
Avandia, manufactured by GlaxoSmithKline (GSK), has been coming under criticism for dangerous cardiovascular adverse effects, including heart attacks and sudden cardiac death. Because of the criticism, the FDA has scheduled a safety review for 13-14 July. The FDA reapproved this drug in 2007 partly on the evidence of GSK’s RECORD study of Avandia.
Thomas Marciniak, an FDA medical team leader, analyzed one of the recent GSK-sponsored trials and discovered that the company had made mistakes in its data analysis and that increased heart risks were indeed present in Avandia users. In some cases, the researchers who conducted the so-called “Record” study, one of the trials cited by GSK, failed to count heart attacks and hospitalizations as heart-related conditions and failed to investigate some deaths in Avandia users to see whether they may have been caused by the drug. In a memo posted today on the FDA website, Marciniak called the study “inadequately designed” and alleged it was conducted to reassure the public of the drug’s safety even though the data suggested otherwise. Another analysis comparing Avandia with Actos, the only other diabetes drug in the same class, found that the likelihood of major heart events like heart attacks or strokes “tended to be less” with Actos and “tended to be greater” with Avandia, according to FDA statistician Bradley McEvoy.
“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate it causes heart attacks.
GlaxoSmithKline withheld study showing Avandia’s associations with heart attacks
A former U.S. Food and Drug Administration official said GlaxoSmithKline withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks, according to two people familiar with her deposition in a lawsuit against the drugmaker.
Dr. Rosemary Johann-Liang, a former manager in the FDA’s drug-safety unit, told lawyers suing Glaxo that the 2001 study found Avandia posed a greater heart-attack risk than rival medicines. Glaxo also didn’t turn over an e-mail from researchers who concluded Avandia “strengthens the signals” of heart ailments, she testified in a pre-trial deposition last month, according to the people.
Johann-Liang left the FDA in 2007 following her recommendation that London-based Glaxo add more information about health risks to Avandia’s label. Johann-Liang stated that FDA officials provided the drugmaker with details of internal agency discussions about beefing up the warnings, and that these leaks “should not have happened” and violated FDA policy.
Johann-Liang’s deposition may be considered by an FDA advisory panel meeting next week in Washington to consider whether Avandia’s ability to control blood-sugar levels outweighs a possible increase in heart attacks, strokes and deaths from cardiovascular disease.
Two new studies show strong evidence that the diabetes drug Avandia increases the risk for heart attacks and strokes
The first study involved more than 35,500 patients and found that Avandia significantly raises the chances of a heart attack. Steven E. Nissen, a Cleveland Clinic cardiologist, conducted the analysis of the data. The data was pooled from 56 studies involving 35,531 patients, including 19,509 who took Avandia. In a paper released online by the Archives of Internal Medicine, the researchers of this study concluded the drug increased the risk for heart attacks from 28 percent to 39 percent. The pair calculated that the drug would cause one heart attack among every 37 to 52 patients who used it for five years.
The results of the second study were released online by the Journal of the American Medical Association. David J. Graham of the FDA’s Center for Drug Evaluation and Research conducted the second new analysis. Graham and his researchers found those 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 Actos. Based on the findings, the researchers estimate that there would be one heart attack, death, stroke or heart failure in every 60 patients who took the drug for one year.
Senate Report states that Avandia estimated to have caused between 83,000 heart attacks between 1999 and 2007
Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee’s ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are asking the U.S. Food and Drug Administration why it permitted a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007. The agency ordered a warning to be included on Avandia’s label in 2007, stating that it might increase the risk of heart attacks, though the data on those risk was inconclusive.
In a letter to FDA Commissioner Margaret Hamburg, the senators said the committee’s report was based on researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents. They said committee investigators had interviewed GlaxoSmithKline and agency employees as well as what it called anonymous whistleblowers.The senate report concluded that based on its knowledge of the heart attack risks, GlaxoSmithKline ”had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner.” Instead, the report stated that the company tried to downplay findings that the drug could increase cardiovascular risks while also working to downplay findings that a rival medication might reduce such risks.
In their letter to the FDA, the senators said the documents the committee reviewed included an analysis conducted by two safety officials at the agency. The analysis compared Avandia to Takeda Pharmaceutical’s diabetes drug Actos, and found that Avandia has an increased risk of heart attack and heart failure. Actos is co-promoted by Pfizer Inc.
Avandia has now been shown to cause heart attacks, sudden cardiac death, strokes, and congestive heart failure in patients taking the drug.
If you have taken Avandia to help treat diabetes and have symptoms of, or have been diagnosed with congestive heart failure or a heart attack, call us today. There is a good chance you have been injured by Avandia and that you are owed financial compensation.
Avandia is prescribed by a doctor to patients with diabetes. Avandia was designed to help control the blood sugar levels in diabetics by helping the body make use of naturally occurring insulin better. Avandia is a brand name for rosiglitazone.Avandia is sometimes combined with other diabetic medications into a single pill. When your doctor prescribes one of these two combinations, the medication will have a different label but still contain Avandia:
* Avandamet – Contains Avandia and metformin.
* Avandaryl – Contains Avandia and glimepiride.
The Most Serious Side Effect
Avandia has been associated with “PPH,” which stands for Primary Pulmonary Hypertension. This condition has no cure, but can be somewhat managed if it’s diagnosed in its early stages. Symptoms that have drawn the most concern from doctors and Avandia attorneys include:
* Chest pains
* Heart murmur
* Fatigue
* Shortness of breath
These conditions can all be debilitating, and they can all lead to the death of a patient. These reports ultimately led to the FDA posting a report of the drug on its Web site in January of 2006.