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.  http://money.cnn.com/2010/09/24/news/companies/FDA_Avandia_GSK_ban.fortune/index.htm?section=money_latest&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%253A+rss%252Fmoney_latest+%2528Latest+News%2529

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experts from the UK Commission on Human Medicines (CHM) decided unanimously at the end of July that the drug should be withdrawn.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.

http://www.theheart.org/article/1120105.do

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. 

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

Image 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

Georgia: Avandia Study

Good find by Pharmalot:

A new study that compares Aandia with Actos found an increased risk of various cardiovascular problems with Avandia, but the studay that hasn’t raised as many concerns.

The authors looked at records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills. What was found? Avandia increased the risk of stroke by 27 percent; heart failure by 25 percent; death by 13 percent; acute myocardial infarction or death by 11 percent; AMI, stroke, or death by 14 percent and AMI, stroke, heart failure or death by 17 percent.

The drug's maker has said about the study:   “it is unclear whether this study has been peer reviewed, and until then, it would be premature to comment. However, it is important to note that there are inherent limitations with retrospective observational studies…Randomized clinical trials remain the gold standard…Results from six randomized clinical trials…show that Avandia does not increase the overall risk of heart attack, stroke or death."

Source here. 

Georgia: Avandia Case Settles in PA

Image by neofedex via Flickr

GlaxoSmithKline Plc (GSK.L) has settled more lawsuits alleging its Avandia diabetes drug caused heart attacks, heading off the first trial in the United States concerning the medicine.

The company said on Tuesday that terms of the settlement remained confidential. It declined to specify how many claimants were involved.

"We can confirm that the case that was scheduled for the first trial in state court in Philadelphia, for June 1, 2010, has been settled," company spokeswoman Claire Brough said in an emailed statement.

"The next case scheduled for trial is in that court and is scheduled for October 2010. GSK has not settled the multi-district litigation pending in federal court."

The latest move follows reports by plaintiff lawyers last month that about 700 cases had been settled for around $60 million.

Source

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: http://online.wsj.com/article/SB10001424052748704508904575191944217066832.html?mod=WSJ_hpp_MIDDLENexttoWhatsNewsSecond

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.

http://www.huffingtonpost.com/madan-kwatra/avandia-and-the-heart-a-r_b_516506.html

Actos and Avandia News

A large study from British Columbia, Canada is pointing to an increased fracture risk with thiazolidinediones (TZDs), used in the treatment of type 2 diabetes [1]. The study, which reviewed fracture risk in more than 84 000 patients receiving either rosiglitazone (Avandia, GlaxoSmithKline) or pioglitazone (Actos, Takeda) vs a sulfonylurea, found that both men and women are at increased risk of broken bones when taking a TZD and hints that pioglitazone may be more strongly associated with fracture risk. Two years ago, the FDA requested that a warning on fracture risk be added to the pioglitazone labeling.

The study appears in the August 10/24, 2009 issue of the Archives of Internal Medicine.

"Larger observational studies are needed, and fracture data from clinical trials need to be fully published so that fracture risks can be known with greater certainty," Dr Colin R Dormuth (University of British Columbia, Vancouver) and colleagues write.

Dormuth et al point out that the research linking fractures to TZD use has not been entirely consistent, with some trials (but not all) suggesting different effects for the two commercially available TZDs and others pointing to a different degree of risk according to gender.

www.segeorgialaw.com

Avandia - Diabetes Drug- Heart Attack Link?

Avandia is manufactured by GlaxoSmithKline for type 2 diabetes. It was first approved for use in 1999. Since then more than 6 million people worldwide have taken this drug. Avandia helps sensitize the body to insulin and helps control blood sugar. According to a recent study by the New England Journal of Medicine, patients taking Avandia have a 43% higher rate of heart attacks.

Several published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

If you believe you were injured because of your use of Avandia, talk with me.