Avandia: Diabetic Drug Comes at a Price

Avandia, a diabetic drug used to treat Type II diabetes has some new consumer alerts. The Joel Bieber Firm is keeping a watch on this drug. If you are taking Avandia and are experiencing heart problems or bone fractures contact the Virginia Avandia lawyers at the Joel Bieber Firm today.

FDA Study Said to Show Avandia Risk
By Marilyn Marchione; Posted 5.24.07, 11:26 PM
(The Associated Press) on WashingtonPost.com

What Choices Do You Have If You’re Taking Avandia?
By Avery Comarow; Posted 5.22.07 on USNews.com

What Did Glaxo Know?
By Matthew Herper; Posted 05.21.07, 1:10 PM ET on Forbes.com

“Glaxo did its own analysis of Avandia, showing results similar to the one published today.”

Glaxo’s Drug Disaster?
By Matthew Herper; Posted 05.21.07, 11:15 AM ET

“Drug safety advocate Steven Nissen says Avandia, a $3 billion-a-year seller, increases the risk of heart attacks 40%.”

Diabetes Drug Avandia Boosts Heart Attack, Death Risk: Study ( Forbes)
05.21.07, 12:00 AM ET

(HealthDay News) “Avandia, a pill widely prescribed by doctors to treat type 2 diabetes, actually increases users’ risk for heart attack by 43 percent, U.S. researchers reported Monday.

The findings on Avandia (generic name rosiglitazone) will appear in the June 14 issue of the New England Journal of Medicine, but were released early on Monday by the journal’s editors due to their public health importance.

“In view of the potential cardiovascular risks and in the absence of evidence of other health advantages, except for laboratory measures of glycemic [blood sugar] control, the rationale for prescribing rosiglitazone at this time is unclear,” concluded Drs. Bruce M. Psaty, of the University of Washington, and Curt D. Furberg, of Wake Forest University, two diabetes experts who co-authored an accompanying editorial in the journal.

Psaty and Furberg also said that, barring any new data to the contrary, the U.S. Food and Drug Administration should take regulatory action to restrict access to Avandia, which is made by GlaxoSmithKline.

However, the editorial noted the findings aren’t conclusive. “A few events either way might have changed the findings for myocardial infarction or for death from cardiovascular causes. In this setting, the possibility that the findings were due to chance cannot be excluded. In their discussion, the authors properly emphasize the fragility of their findings.”

GlaxoSmithKline responded by issuing a strongly worded press release defending the safety of the drug. In the statement, company officials said that GSK “strongly disagrees with the conclusions reached in the New England Journal of Medicine article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.”

The article goes on to read…

“For the new study, Dr. Steven Nissen and his colleague Kathy Wolski at the Cleveland Clinic evaluated 42 studies that compared patients taking Avandia with patients not using the drug. The studies included almost 28,000 patients, 15,560 of whom were taking Avandia.

The researchers found the risk of a heart attack was increased 43 percent among those taking Avandia, and there was a 64 percent increased risk of dying from cardiovascular causes, compared with patients not taking the drug.

Among patients taking Avandia, 86 had heart attacks compared with 72 among patients not on the drug. In addition, 39 patients taking Avandia died from cardiovascular causes compared with 22 patients not receiving the drug, Nissen and Wolski found.

“Rosiglitazone was associated with a significant increase in the risk of myocardial infarction [heart attack] and with an increase in the risk of death from cardiovascular causes that had borderline significance,” the authors wrote.

“Until more precise estimates of cardiovascular risk of this treatment can be delineated in patients with diabetes, patients and providers should carefully consider the potential of rosiglitazone in the treatment of type 2 diabetes,” they concluded.

In their editorial, Psaty and Furberg said the new data about Avandia highlights the failure of the FDA’s drug-approval process.

“During the market life of rosiglitazone, tens of millions of prescriptions for the drug have been written for patients with type 2 diabetes,” they wrote. “Insofar as the findings of Nissen and Wolski represent a valid estimate of the risk of cardiovascular events, rosiglitazone represents a major failure of the drug-use and drug-approval process in the United States.”

Excerpts from an article in the 2006 Associated Press…

“A newer drug appeared to delay the progression of the most common form of diabetes a little longer than two older medications but also raised the risk of heart problems, weight gain and fractures a large study has found.”

The article goes on to read…

“The results, along with the higher cost of the new drug, suggest that metformin, sold as Glucophage and other brands, should remain first choice from newly diagnosed patients with Type II diabetes, several specialists said.”

Type II diabetes is the most common form among adults, affecting more than 200 million people worldwide. If you are currently taking Avandia to maintain your diabetes, and are experiencing any of the symptoms mentioned above, contact the Joel Bieber Firm today.

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