The New York Times published a story on February 19th about the dangers of Avandia, an enormously popular – and profitable – diabetes medication produced by GlaxoSmithKline. The report was authored by two FDA researchers and declares in straightforward English that “Rosiglitazone [Avandia] should be removed from the market.” Language that definitive is rare from the FDA; the reason for such direct comment is that the report is an internal document, one of dozens that have debated the dangers of Avandia over the past seven years.

The drug is known to increase the danger of heart attacks in diabetics, who are prone to heart problems anyway. Avandia was linked to 304 deaths in the third quarter of 2009 alone. According to one FDA report, “…if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month…”

Debate but No Decision from the FDA

A public news story about these internal FDA research reports reflects the long and controversial history of debate over Avandia and the threat it poses to diabetics who use it. It also reflects the frustration of some of the FDA’s research staff, as similar reports have been issued in the past but the FDA has chosen to leave the medication on the market. Also in play is an unusual Senate investigation into the drug and its manufacturer – the Senate report is scheduled for release on February 20th. Among its conclusions: that GlaxoSmithKline (GSK) has failed to warn users of the medication about its potential dangers.

The debate on Avandia goes back to at least 2003, when the manufacturer concluded a study that showed diabetics who took Avandia had far more heart problems than those who used an alternative medication. In 2006 at the insistence of European regulators GSK conducted and concluded a “meta-study” showing that Avandia increased the risks of serious heart problems by nearly a third. In 2007 the FDA issued a warning about the drug, but stopped short of recall – choosing to leave it on the market.

Questionable Company Research

While sales have dropped as the result of multiple studies and public commentary over the drug’s dangerous side effects, GSK continues to sell the product and market it aggressively. As the result of continuing pressure the company has launched yet another study that is currently recruiting diabetic participants, although some within the FDA have characterized the study’s methodology as “unethical and exploitative.” The test is expected to take a decade or so, with completion expected in 2020. However the patent on Avandia expires in 2012, meaning the drug will no longer be the exclusive profit center that rang up $3.2 billion in sales in 2006 alone.

The reports of heart problems associated with Avandia have been rampant over the years, while GSK and the FDA have kicked the issue back and forth. If you are a diabetic who has taken Avandia and suffered heart problems, contact an attorney about your rights to compensation. GlaxoSmithKline will be spending years in court over their insistence in keeping Avandia on the market.

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msnbc.com

Let's talk about Avandia
San Francisco Chronicle
You probably have been following the story about Avandia, the diabetes drug that has been linked in some studies to a higher risk of heart attack and stroke …
What Now for the Diabetes Drug Avandia?U.S. News & World Report
Avandia on TrialWall Street Journal
Patients taking Avandia should keep on doing so, doctor groups sayLos Angeles Times
Reuters -msnbc.com -BusinessWeek
all 2,186 news articles »

Let’s talk about Avandia – San Francisco Chronicle is a post from: Avandia Lawsuit | Avandia Lawsuits

East Texas doctor, pharmacist weigh in on diabetes drug, Avandia
KLTV
But in a split decision, the FDA announced the diabetes drug Avandia will remain on the market. You've seen the ads. You've heard the warnings. …

and more »

East Texas doctor, pharmacist weigh in on diabetes drug, Avandia – KLTV is a post from: Avandia Lawsuit | Avandia Lawsuits

New York Times (blog)

What Now for the Diabetes Drug Avandia?
U.S. News & World Report
For the past three years, the evidence against Avandia has been building. A 2007 study found a 43 percent increase in heart attacks and a 64 percent spike …
Patients taking Avandia should keep on doing so, doctor groups sayLos Angeles Times
Don't dump Avandia, diabetes groups urge patientsReuters
Avandia may be restricted. Now what to do?msnbc.com
CNN -Boston Globe -TODAYonline
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Gossip Jackal

FDA Panel Rejects Vivus Weight-Loss Drug Qnexa
Wall Street Journal
Most panel members were also part of the Avandia panel that met earlier this week to discuss whether to keep that drug on the market amid concerns that the …
Arena Pharma Rallies On FDA Optimism; Vivus Shares HaltedWall Street Journal
Vivus' Qnexa takes center stage during panel reviewFierceBiotech
3 New Weight Loss Drugs Waiting for FDA OKsADI News (blog)
MarketWatch
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Straits Times

Diabetics Urged to Confer With Their Doctor About Avandia Use
BusinessWeek
THURSDAY, July 15 (HealthDay News) — One day after a US advisory panel recommended that the controversial diabetes drug Avandia stay on …
Doctors Face Difficult Decision On Prescribing AvandiaWBUR
What is the meaning of the Avandia vote?FiercePharma
HSA reviewing AvandiaStraits Times
Forbes (blog) -KOSA -CBC.ca
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Avandia Hearing Reveals Fundamental Flaws at FDA
Union of Concerned Scientists
The advisory panel met yesterday and today to review safety questions regarding Avandia, a GlaxoSmithKline diabetes drug that has been linked to heart …
Avandia: The Key Vote Is NegativeForbes (blog)
Close the FDA Approval GapHuffington Post (blog)
Whistleblower News Roundup 7.15.10Government Accountability Project (blog)

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Panel Doesn't Recommend Pulling Avandia
OzarksFirst.com (blog)
The FDA was hoping to end the debate over whether Avandia was too dangerous to sell to diabetics. The drug has been under fire since 2007 when the first …
The Avandia ControversyWebMD (blog)
Avandia's Sales Drop Far Behind ActosNew York Times (blog)
Avandia decision could bolster rivals' salesMedical Marketing and Media

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Washington Post

Patients taking Avandia should keep on doing so, doctor groups say
Los Angeles Times
Diabetics taking Avandia who are concerned about the drug following Wednesday's decision by a Food and Drug …
Don't dump Avandia, diabetes groups urge patientsReuters
Avandia may be restricted. Now what to do?msnbc.com
Concerned about Avandia? Here are other optionsCNN
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TheBull.com.au

European shares tumble, economy concerns persist
Reuters
L) added 1.8 percent in a relief rally after a US panel of health experts voted to keep the drugmaker's diabetes pill Avandia on the market but with new …
European stocks resume rally after JPMorgan resultsReuters
European stocks dip; eyes on JPMorgan resultsReuters
Closing stock market indices outside the USForexyard

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