Avandia

Avandia Attorneys

UPDATE: FDA Develops More Stringent Criteria for Prescribing Avandia Due to Significant Cardiac Risks


For More information, visit the FDA site here.

UPDATE: FDA Cites Cardiac Risks in Severely Restricting Avandia

Regulators in Europe have prohibited the sales and use of Avandia and in the US, the FDA only permits its use in cases where every other diabetic drug has failed. Use in the US will require attestation by both the patient and physician that no other drug is a viable option to the patient and the patient fully understands the risks.

Once the largest selling diabetes drug around the world and reaping GlaxoSmithKline over $5 billion, Avandia sales will most assuredly drop to nearly nothing now that regulators have confirmed the substantial dangers that have been recognized by researchers for some time. Steven Nissan of the Cleveland Clinic and FDA investigators have been sounding the warnings concerning the significant cardiac risks associated with the drug.

Avandia – A History of Danger

Avandia is an anti-diabetic drug marketed by GlaxoSmithKline. Avandia is an “insulin diabetessensitizer,” which means that the drug functions by binding to certain receptors in fat cells, thereby enabling the cells to be more responsive to insulin. This, in turn, helps Type 2 diabetics control their blood sugar.  One of the known problems suffered by diabetics is the increased risk of cardiovascular disease. So, any drug that “might” increase that already-existing risk is potentially dangerous to patients.

Avandia has been an extremely successful drug for GlaxoSmithKline. It is estimated that more than 20 million patients in the United States have purchased this new drug in hopes of staving off the ravages of diabetes. Many patients were hopeful that Avandia, which helps to sensitize the body to insulin, would fulfill the promises that other drugs failed to deliver. Sadly, it has disappointed them as well.

Through the discovery of internal documents, it is clear that not only did GSK know of the cardiac risks associated with its drug as soon as Avandia was introduced in 1999, but that the company lobbied aggressively to prevent those risks from becoming public knowledge.

In the fall of 1999, SmithKlineBeecham (which merged with Glaxo in 2000 to form GSK) secretly began to study whether its product or a competing pill, Actos, was safer for the heart.

What SmithKlineBeecham learned was that not only was Avandia not superior to Actos, but that Avandia was riskier to the heart.  Company executives quickly began denigrating the studies, describing the them as “way under the radar,” and senior management directed that “these data should not see the light of day to anyone outside of GSK.” It is no wonder, then, that the consumer and the FDA did not discover the dangers of Avandia until recently — GSK buried it.

As early as 1999, adverse event reports began to pour in from patients and healthcare providers who suspected that Avandia was causing more harm than good. In particular, there were a number of adverse event reports relating to fluid retention, congestive heart failure, and heart attacks. Some of these same adverse events had been reported in pre-approval clinical trials, but the findings in those trials were deemed insufficient to prevent approval of the drug. Subsequent studies also showed an increased risk of cardiovascular events in patients who use Avandia, but, time and again, the drug manufacturer has contended that such results were unreliable or insufficient to signal a safety alert.

In an effort to answer serious questions regarding the safety of Avandia, the New England Journal of Medicine published a meta-analysis in May of 2007, essentially a pooling of a number of studies (in this case, 42 studies) in hopes of obtaining statistically significant results regarding risk of the drug. The meta-analysis did show a slight increase in the risk of heart attacks and cardiovascular deaths in patients using Avandia over other diabetics, yet the study was still subjected to much debate and criticism. While this scientific debate is important, such debate should not be used to quiet critics or prevent patients from receiving adequate warning regarding risks. Diabetics already face staggering risks of developing cardiovascular disease, heart attacks, and sudden cardiac death. Given this susceptibility, it is inconceivable that patients would choose to take a drug that would further increase their cardiac risks. Yet, time after time, drug manufacturers have preyed on patients’ desperation for treatment options to hawk their wares. Sadly, until the drug’s warnings were enhanced in May of 2007, a number of diabetics unknowingly ingested Avandia and likely suffered unnecessary heart attacks or died. More than 13,000 injured patients and relatives of deceased patients are currently pursuing lawsuits against GlaxoSmithKline in state and federal courts, primarily in Philadelphia.

Why bury dangers such as these? In a word…profits. Documents demonstrate an estimated loss of $600 million dollars between 2002 and 2004 alone if Avandia’s cardiovascular safety risk were intensified. 

Recently, an FDA panel has recommended, in a very close vote, to allow Avandia to remain on the market with significant warnings. This surprising finding contradicts recommendations by the FDA’s own independent investigator, Dr. Thomas Marciak, that GSK’s studies were flawed, “inappropriate and biased.”

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