Avandia Consumer Alert: More Negative Data Emerges as FDA Advisory Board Recommends Stronger Warnings

July 23, 2010

"Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust" [1]  
Senator Max Baucus, Chairman on Committee of Finance

Avandia is a drug used to control blood sugar for Type 2 diabetics, but has been associated with multiple safety issues, including heart attacks, congestive heart failure, strokes and bone fractures.[2]  Last week, two-thirds of the members of a Federal Drug Administration (FDA) expert advisory committee recommended that Avandia should either be withdrawn from the market or have strong restrictions on sales, such as allowing only certain physicians to prescribe it or requiring special education for doctors and patients.  Only 3 committee members voted in favor of keeping Avandia on the market with only its current warnings. 

The decision came after the committee reviewed new studies on Avandia that provided further evidence of the drug's risks.  The largest study to date on Avandia, commissioned by the FDA and published in June 2010, found that use of Avandia is associated with an increased risk of stroke, heart failure and death compared to the diabetes drug Actos.[3]  According to Dr. David Graham, the lead FDA researcher:  "If you treated 60 people for a year with Avandia, you would cause one extra case of heart attack, stroke, heart failure or death compared to if you had treated the 60 patients with Actos." [4]  Dr. Graham noted this data indicates that 100,000 Americans may have died or had heart attacks, strokes or heart failure associated with Avandia since the drug came on the market in 1999.[5]

In June 2010, an updated analysis of a 2007 study found similar results: Avandia is associated with "a significant increase" in heart attack risk.[6]  The studies' author, who analyzed the results of 56 clinical trials, has stated: "I think what we can say confidently in looking at the totality of data in 2010, Avandia increases the risk of heart attack, compared to other diabetes drugs by about a third."[7]

Just as the FDA advisory committee was meeting, the New York Times reported on its review of the drug manufacturer's internal documents, which found that the Avandia manufacturer hid evidence of Avandia's heart risks from the FDA and from the public.[8]  The New York Times reported that the manufacturer SmithKline Beecham (formerly known as GlaxoSmithKline, or GSK) conducted a study over ten years ago that demonstrated Avandia was riskier to the heart than a similar diabetes drug, and that the company failed to publish this study or to submit it to the FDA.[9]   Referring to the adverse results of the study, an internal 2001 e-mail cautioned: "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK."[10]

Robins, Kaplan, Miller & Ciresi L.L.P. is investigating potential claims on behalf of Avandia patients.  If you wish to speak to us about a potential claim or an injury caused by Avandia, please call Kathy Neuman, R.N., B.S.N. at 1-800-553-9910 or contact her via email at contact us.

[1] United States Committee on Finance Press Release, Grassley, Baucus Release Committee Report on Avandia, Feb. 10, 2010, available at http://finance.senate.gov/newsroom/chairman/release/?id=bc56b552-efc5-4706-968d-f7032d5cd2e4 (last visited July 22, 2010) (Quoting Senator Max Baucus, Chairman of the Committee on Finance).
[2] PD Home et al. Rosiglitazone Evaluated for Cardiovascular Outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomized open-label trial.  Lancet. 2009; 373 (9681):2125-2135; YK Loke et al. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta analysis. CMAJ. 2009; 180(1):32-9.
[3] David J.Graham, et al, Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone  JAMA. 2010; 304(4). available at http://jama.ama-assn.org/cgi/content/full/jama.2010.920, published online June 10, 2010 (last visited July 22, 2010).
[4] Drug Poses Safety Test for FDA, Online, NPR Morning Edition, (June 29, 2010),http://www.npr.org/templates/story/story.php?storyId=128174678
[5] Id. 
[6] Steven E. Nissen,  Kathy Wolski,. Effects of Rosiglitazone on the Risk of Myocardial Infraction and Death from Cardiovascular Causes, N Engl J.Med 2007; 356:2457-2471, available at http://content.nejm.org/cgi/content/full/356/24/2457?ijkey=d328d24a889b24bd45bdace8f781c5e5e8517cf0 (last visited July 22, 2010);  Steven E. Nissen, Kathy Wolski,  Rosiglitazone Revisited: An Updated Meta-Analysis of Risk for Myocardial Infarction and Cardiovascular Mortality, Arch Intern Med.  2010; 170(14), available at http://archinte.ama-assn.org/cgi/content/full/2010.207 (last visited July 22, 2010).
[7] Diabetes Drug Poses Safety Test for FDA, NPR Morning Edition (June 29, 2010), http://www.npr.org/templates/story/story.php?storyId=128174678.  (quoting Dr. Steven Nissen).
[8] "Diabetes Drug Maker Hid Test Data, Files Indicate, New York Times (July 13, 2010). http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?th&emc=th
[9] Id. 
[10] Id. (quoting SmithKline executive Dr. Martin I. Freed)

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