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Avandia Recall Side Effects
GlaxoSmithKline Concealed Truth About Avandia Heart RisksIn an article published in the New England Journal of Medicine (NEJM) on May 21, 2007, it was reported that "treatment with rosigliazone (Avandia) was associated with a significant increase in the risk of myocardial infarction, and an increase in the risk of death from cardiovascular causes that was of border-line significance...our findings are worrisome because of the high incidence of cardiovascular events in patients with diabetes". If you or a loved one have used Avandia and believe that you suffered medical injuries as a result of the Avandia recall side effects, contact our Defective Drug Attorney to find out how we can help you .
With patients who had taken Avandia for short periods of time, the NEJM article states that "in susceptible patients, rosiglitazone therapy" might even be "capable of provoking myocardial infarction or death from myocardial causes after short-term exposure". The damages from the Avandia recall side effects, even for a short period of time, are serious. If you have taken this drug don't hesitate to contact a New York Defective Drug Lawyer.
Avandia Manufacturer Failed to Disclose Heart Risks
There are two essential components of any drug on the market: First, it must be efficacious, that is, effective to respond to the illness it is intended to treat. Second, it must be safe. Applying the two essential ingredients to Avandia, while it might have been a useful drug to combat "type 2" diabetes, it posed too many risks to other medical entitities (i.e. heart attacks) to qualify as a safe drug. In fact, if the manufacturer had disclosed to the FDA that its own clinical trials were not sufficiently broad to test the impact of Avandia (and its risk of producing cardiovascular disease as a side effect), the likelihood is that the FDA would have been more cautious in its approval of the drug.
While GlaxoSmithKline conducted clinical trials of Avandia, testing for efficacy and safety of its product, the New England Journal of Medicine article states that "the manufacturer's public disclosure of summary results for rosiglitazone clinical trials is not sufficient to enable a robust assessment of cardiovascular risks".
The FDA does not conduct its own clinical trials, but relies upn the information it receives from the pharmaceutical manufacturer contained within its new drug application (NDA) packet, which continues to grow as more information and documents are submitted to the agency. Here, GlaxoSmithKline fell far short of the "public disclosure of summary results...sufficient to enable a robust assessment of cardiovascular risks". (NEJM)
GlaxoSmithKline Charged with Hiding Truth About Heart Risks
On May 23, 2007 the Senate Finance Committee, through Senators Max Baucus and Chuck Grassly, Chairman and Ranking Member of the committee, sent scathing letters to the FDA, and GlaxoSmithKline.
This is part of the Baucus letter:
"What we are learning about the handling of Avandia by both GlaxoSmithKline and the FDA is appalling and unacceptable. Both the drug company and the FDA have some major explaining to do about what they knew about Avandia, when they knew it, and why they didn't take immediate action to protect patients. The number one priority for drug manufacturers and the FDA must be patient safety. Medicare and Medicaid patients-and all Americans- must never be put at risk like this again."
Senator Grassly was equally critical in stating:
"We need to know if this is another Vioxx, where the FDA sat on its hands and endangered lives. The FDA has talked a good game and how it's beefed up post-market surveillance over the last two years, but a case like this undermines that claim. It'll take more than administrative reforms to fix the system within the FDA..."
FDA Was Warned of Avandia's Heart Risks in 2000
In 2000, a reknowned diabetes physician who had made an intensive study of Avandia and its risk factors, sent a letter of warning to the FDA expressing his deep concerns about Avandia side effects and its cardiovascular risks. As stated in a column published in the New York Times on May 24, 2007:
"The letter in 2000 to the FDA was written by Dr. John B. Buse, chief of endocrinology at the University of North Carolina at Chapel Hill, who is about to become the president of the American Diabetes Association. His letter from 7 years ago sounded an alarm about Avandia, citing "a worrisome trend in cardiovascular deaths and severe adverse events" among patients using the drug".
Despite the warnings, little was done, either by GlaxoSmithKline, or the FDA, to notify the public of the hidden dangers of heart attacks connected with the use of Avandia. Instead, 6 million patients continued to use Avandia unaware that as "type 2" diabetes patients who were on a regular regimen of Avandia, they were not only risking their health by developing cardiovascular disease - but risking their lives as well!
GlaxoSmithKline Reports $3 Billion in World Wide Sales in 2006
Avandia, introduced in 1999 became one of the most profitable drugs in the pharmaceutical industry by 2006. More than 11 million prescriptions were written, producing gross sales of almost $3 Billion in 2006. Second only to Actos, Avandia has risen as a top money-making diabetes drug. It is little wonder that GlaxoSmithKline continues with its denial that Avandia-use causes an increase of cardiovascular diseases despite the recent safety alert issued by the FDA that, "treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart related adverse events than patients treated with placebo or other anti-diabetic therapy".
Dr. Steven E. Nissen, lead author of the article in the NEJM answered to a New York Times reporter: "It's [Avandia] a huge risk," estimating that "tens of thousands of people" suffered heart attacks, all resulting from the use of Avandia, a diabetes drug that was supposed to be not only effective but safe. The morbidity and mortality of the second component, "safe", unquestimately belies that statement.
Legal Help for Avandia Users
If you, a family member or friend have used Avandia and have had suffered as a result of avandia recall side effects, please contact the New York Drug Attorney of Finz & Finz, P.C. today at (888) FINZ-FIRM to speak with an experienced litigation attorney now or fill out the Free Avandia Case Evaluation form on the right of this page.