"“We have lent a huge amount of money to the U.S. Of course we are concerned about the safety of our assets. To be honest, I am definitely a little worried.” "

Chinese premier Wen Jiabao 12th March 2009

""We have a financial system that is run by private shareholders, managed by private institutions, and we'd like to do our best to preserve that system."

Timothy Geithner US Secretary of the Treasury, previously President of the Federal Reserve Bank of New York.1/3/2009

Wednesday, August 15, 2007

FDA issue "Black Box" warning for Diabetes Type II drugs, Avandia and Actos

The Food and Drug Administration (FDA) have determined that a "black box" warning highlighting "may cause or worsen heart failure in certain patients" has to be added to thiazolidinedione class of type 2 diabetes drugs, including GlaxoSmithKline's Avandia (rosiglitazone) and Takeda's / Eli Lilly Actos (pioglitazone). See this website for SKF/Avandia official response and here for Actos - July 30th Press Release from Takeda here.

This decision results from an FDA review of post-marketing reports that showed warning signs of heart failure found - significant weight gain and oedema, which associated with poor outcomes, including death, the agency added. This follows a "meta-analysis" published by Dr. Steven Nissen, chief cardiologist for the Cleveland Clinic, in the New England Journal of Medicine which detailed a major study showing inc reased risks of heart attacks, especially amongst Diabetes Type II patients without other signs or indicators of heart problems..

GlaxoSmithKline's Avandaryl (rosiglitazone plus glimepiride), Avandamet (rosiglitazone plus metformin), as well as Takeda's Duetact (pioglitazone plus glimepride) will also carry the new "black box" warning.

An advisory panel had earlier in June voted 22-1 to recommend that GlaxoSmithKline's type 2 diabetes drug, Avandia (rosiglitazone), should remain on the market, despite data suggesting that it increases cardiovascular risks. The panel had also recommended that the product's label should be updated with new safety warnings.The advisory panel had reviewed a 436-page report which was a compendium of reviews released in advance of an advisory panel hearing held on Monday June 30th.

In 2006 Avandia sales totalled $3 billion. Barbara Ryan, analyst for Deutsche Bank North America, said in a published report that US Avandia prescription volumes were down 50 % in the week ended July 20, compared to the week preceding May 18, when Nissen's article was published. For those same time periods, Actos US prescriptions were up 19 %. Glaxo shares rose 4% on Tuesday after the news.

Diabetes drugs to get stronger heart-failure warning - (Bloomberg)
FDA to strengthen diabetes drug warnings - (CNN)
GlaxoSmithKline Updates Prescribing Information for Avandia - (Pharmalive)

If you take Avandia or Actos you should inform yourself of the risks involved - Actos / Takeda / Lilly say "Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath while taking ACTOS. " - I did and I spoke to the Doctor.

My Doctor says (God Bless her), "We are going to ignore the Nissen report".. what do you do ? Change Doctor, Flip a coin ? Fuller discussion of the Nissen report here in an earlier post.

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