We are in settlement negotations with GlaxoSmithKline (”GSK”), the manufacturer of Avandia.  Submit your Avandia case for a Free Case Evaluation or call 314-662-2836, and one of our experienced attorneys will evaluate your case.  This is not a class action;  your case will be individually litigated.    

Our national law firm represents individuals injured by America’s largest corporations.   Our lawyers have recovered over $810 million for our clients, including individual settlements of over $10 million and class-wide settlements of over $90 million. It is our clients who are our most important asset.

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A federal medical advisory panel recommended Wednesday that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.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.

Submit your Yaz/Yasmin case for a Free Case Evaluation or call 314-662-2836, and one of our experienced attorneys from a national law firm will evaluate your case.

We will file your Yaz/Yasmin case individually, not as part of a class action: We represent each women suffering from Yaz on 100% contingency basis which means that there are never any legal fees until we settle your case. We will file your case individually, not as a class action.

Yaz/Yasmin Information

The use of the birth control Yaz/Yasmin has been associated with serious side effects, which include pulmonary embolism, stroke, deep vein thrombosis (DVT), heart attack, and even death.

Since 2004, at least 50 deaths have been reported in women taking Yasmin and similar contraceptives. Some of these women were as young as 17.

A key ingredient in these drugs can raise blood potassium levels and cause:
Heart attack
Stroke
Gallbladder disease
Kidney disease
Pulmonary embolism
Deep vein thrombosis
Venous Thromboembolism (VTE)
Liver tumors
Death

Yasmin and Yaz are birth control pills manufactured by Bayer Healthcare. The generic brand Ocella is marketed and distributed by Barr Laboratories, Inc. They are combination oral contraceptives [COCs], meaning that like most birth control pills, they contain an estrogenic component and a progestational component. These steroidal components work together in COCs to suppress ovulation, fertilization and implantation and thus prevent pregnancy.

Yasmin and Yaz: Birth Control Pills with a “Fourth Generation” Progestin
While Yasmin and Yaz contain the same estrogenic compound, ethinyl estradiol that has been used in the lower dose Pill, or COCs, for decades, the progestin in Yasmin and Yaz is unique. Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin. No other birth control pills contain drospirenone, except for a recently approved generic version of Yasmin and Yaz, marketed by Teva under the trade name Ocella. In addition, a newly approved hormonal product for menopause called Angeliq contains drospirenone.

Because drospirenone is new, there are not decades of data available to support its safe use as there are with the second generation progestins. Studies which were done before FDA approval, however, indicate that drospirenone has certain effects that are different than those of traditional second generation progestins and potentially more dangerous. Specifically, drospirenone causes an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances, such as extrasystolies, pauses or bradycardia.

If left untreated, hyperkalemia can be fatal. In particular, if hyperkalemia disrupts the normal heart rhythms, the flow of the blood through the heart can be slowed to the point that it permits blood clots to form. Blood clots in the heart can then lead to heart attacks, or break off and travel to the lungs where they can cause pulmonary embolus, or travel to the brain causing stroke.

Yaz/Yasmin links:

According to a new study published in the British Medical Journal, Yaz and Yasmin, carry a higher risk of blood clots compared with others birth control bills. New York Times (9/25/09): “Health Concerns Over Popular Contraceptives.”

“The U.S. Food and Drug Administration is requiring Bayer HealthCare Pharmaceuticals to run ads correcting claims about a popular birth control pill. Federal health officials said previous ads overstated the ability of the birth control pill Yaz to cure acne or reduce premenstrual mood swings and played down potential health risks,” The New York Times reported this year. New York Times (2/9/09): “A Birth Control Pill That Promised Too Much.”

The FDA warning letter regarding Yaz/Yasmin