Forget the black box for now..here's FDA's Janet Woodcock speaking clearly and confidently on what the agency decided and what the new labeling means:
"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.
The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."
Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.
http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.
The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."
Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.
http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
