Nov 25 U.S. health regulators on Monday said
they would lift restrictions on the use of GlaxoSmithKline Plc's
once widely used diabetes drug Avandia after determining
that it did not increase the risk of heart attacks.
The U.S. Food and Drug Administration, following its review
of a large clinical trial called Record, said it found that the
trial showed no elevated risk of heart attack or death in
patients being treated with Avandia when compared with
standard-of-care diabetes drugs.
These data do not confirm the signal of increased risk of
heart attacks that was found in an analysis of previous clinical
trials first reported in 2007, the FDA said in a statement.
Avandia, which had been one of Glaxo's top-selling medicines
with sales of $3.2 billion in 2006, was pulled from the market
in Europe and had severe restrictions placed on its use in the
United States in 2010 due in part to ambiguity about a possible
increased risk of heart attack and stroke seen in the Record
study, as well as a review of other studies.
The drug was placed in a highly unfavorable light in 2007
after Dr. Steven Nissen, head of cardiology at the Cleveland
Clinic, reported results of a so-called meta-analysis in which
data from 42 studies was pooled and analyzed, showing a 43
percent increased risk of heart attack from Avandia.
GlaxoSmithKline could not immediately be reached to comment
on the FDA decision. But the British drugmaker had previously
said it was not likely to put its marketing muscle behind
Avandia again, even if the FDA were to lift the usage