Replies to post #49133 on Biotech Values

[Bio_pete]

POZN - " I don't know if the drug will get approved because naproxin has some cardio effects as does immitrex and the fda may be concerned that combining the drugs may make the cardio effects worse."

POZN's management has indicated that the FDA's concerns centered around possible increased cardiac risks from the combo. However, it looks like the FDA may have errored by black boxing the entire group of NSAIDS. Trexima's approval may have a lower bar since Naproxen's cardiovascular risks were overblown when Trexima originally went before the FDA for approval.

"The FDA is adding ‘black box’ warnings to all prescription and over-the-counter pain relievers – even to naproxen (Aleve) – which the evidence shows is safe,” said Furberg, who serves on the FDA Drug Safety and Risk Management Advisory Committee." http://www.seniorjournal.com/NEWS/Health/2007/7-04-25-FDACauses.htm

[ThomasS]

Dr Bio, does the FDA go looking at safety when "the standard elderly patient," (such as my Mother) has 15 different prescriptions, some of which are clearly hazardous alone?
I have 6 or 7 myself.

Aren't these "drugs in combination?"
(I realize this is apples and Kiwi fruit, so don't bother pointing that out. But, you get the idea.)