Showing posts with label avandia north carolina. Show all posts
Showing posts with label avandia north carolina. Show all posts

Tuesday, September 28, 2010

Why the EU banned Avandia but the FDA Didn't

From Fortune and CNN/Money:

Avandia has taken some beatings over the years, but it pretty much took a fatal blow yesterday. That's when the Food and Drug Administration ruled to keep the drug on the market in the United States with some serious restrictions.
Those being: GlaxoSmithKline (GSK), the drug's manufacturer, can't promote it. Patients currently on the drug will be advised to switch to another similar treatment, if possible. Doctors can't prescribe Avandia to new patients without explaining in detail why it might be more likely to cause a heart attack than other options. The FDA basically mandated everything short of putting a skull and crossbones on the label. But here's the rub: The European Union's European Medicines Agency dispensed with the subtleties and outright banned Avandia from being sold. Why didn't the FDA?

For more go here.

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Thursday, September 09, 2010

Georgia News: Avandia in the UK

The diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) is once again in the media spotlight  in the UK, where it has emerged that experts from the UK Commission on Human Medicines (CHM) decided unanimously at the end of July that the drug should be withdrawn.

This recommendation was not made public, however, in line with protocol. It was communicated to the British drug-licensing agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), which instead sent out "Dear doctor" letters reiterating safety information with regard to rosiglitazone from 2007, including a suggestion to consider alternative treatments where appropriate.

En Espanol:

El rosiglitazone de la droga de la diabetes (Avandia, GlaxoSmithKline) es una vez más en los medios ilumina con proyector en el RU, donde ha surgido que expertos de la Comisión del RU en Medicinas Humanas (CHM) decidió unánimemente a fines de julio que la droga debe ser retirada. 

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Thursday, September 02, 2010

Georgia Avandia: News of Problems in Forums/Chat Rooms as early as 04?

AvandiaImage by neofedex via Flickr
A new report says patients began discussing the risks of GlaxoSmithKline diabetes drug Avandia in online forums and blogs well before a meta-analysis linked it to higher heart-attack risk. Neither physicians nor company officials acknowledged their worries, contributing to an alarming drop in patient sentiment and, according to authors, a lost opportunity to reach out and restore trust.

Patients first started questioning whether it was safe to take Avandia given their situation, especially those with congestive heart failure (CHF), in 2003 and 2004, but the drug was still seen as a good alternative for many with type 2 diabetes, notes the report. Negative comments began referencing Avandia risks in 2005 but were more likely to grow out of frustration with weight gain and edema—potential side effects of drugs in the thiazolidinedione (TZD) class.

The tone changed in 2006. Discussions went beyond swelling and weight gain to comparisons with other products shown to lower blood sugar without these risks, such as Eli Lilly/Amylin's Byetta and Merck's Januvia. Chatter about other side effects lit up message boards, as well. Analysis of comments shows patients connected edema to an increased risk of CHF, and some reported increased blood pressure. Anger and frustration grew, as physicians seemed disconnected from the concerns.

More here
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Wednesday, April 28, 2010

GA Avandia: TIDE Trial


Looks like folks will have to wait until July of 2010 to see if the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, commissioned by the FDA and pitting rosiglitazone against pioglitazone (Actos, Takeda Pharmaceuticals), will be allowed to continue.

There are concerns about whether or not the informed consent forms are up to snuff:

"If people were to reexamine the informed-consent forms, particularly in light of the data as of 2010, they may have second thoughts about whether they want to continue the trial at their own institution."

More at the link, above.

Sunday, April 18, 2010

Georgia: Report - FDA May Halt Avandia Safety Study

According to the Wall Street Journal report, FDA commissioner Margaret Hamburg wrote a letter to Grassley in late March saying that the agency is reassessing a trial that compares the drug to a drug made by Takeda Pharmaceutical Co called Actos. That trial is also called the TIDE trial, according to the Journal.

FDA Principal Deputy Commissioner Joshua Sharfstein told the Journal that the decision on the trial "cannot be de-linked from the agency's view of Avandia."

Sharfstein said no decision had been made on the trial -- the FDA has asked a government scientific panel to review the ethics of head-to-head trials, the Journal said.

Link here:

Tuesday, March 30, 2010

Georgia: Avandia and the Heart: A Reminder That Drugs Can Harm (HP)

From the HuffPo:

Diabetes is particularly detrimental to the heart, and heart problems are the eventual cause of death for most patients with diabetes. Given this, it is extremely worrisome that Avandia, a drug marketed to treat diabetes, has been found to harm the heart.

The recognition that drugs can cause harm is nothing new. A recent example is the painkiller Vioxx which was found to harm the heart and taken off the market in 2004.

While many extremely toxic drugs are eventually taken off the market, several drugs that are quite harmful remain available, albeit with a warning from the FDA. An example is acetaminophen, the active ingredient in some over-the-counter painkillers (such as Tylenol) and many cold medications, which can cause severe liver damage.

If every drug has the potential to cause harm, how can an average person protect himself or herself from the adverse effects of drugs that are approved by the FDA?

The answer is education.

Tuesday, January 26, 2010

Avandia Lawsuits in North Carolina/South Carolina? Heart Attack/Stroke

There is a 3 year Statute of Limitations in N.C. and S.C.:

From several sites:

Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were received for
rosiglitazone in the first three quarters of 2009, more than any other drug we monitor. Rosiglitazone is an oral medication for treating Type 2 or adult onset diabetes. Most deaths were attributed to cardiovascular causes, a problem for which the FDA has required warnings. While these cases do not appear to signal previously undetected risks of rosiglitazone, the large number of reports alleging serious and fatal injuries associated with rosiglitazone further reinforces concerns about its cardiovascular safety. The company, GlaxoSmithKline, told us it believed most reports were generated by lawsuits.

In February 2010 the FDA announced it was conducting an overall safety review of
rosiglitazone and would present its findings to a special advisory committee meeting in July.

"Rosiglitazone should be removed from the market," concluded Dr. David Graham and Dr. Kate Gelperin, both epidemiologists with the FDA. Linkavandia