Merck acquired Foradil® from legacy Schering-Plough in the bust-up, last November. The Wall Street Journal is carrying Dow Jones' Jennifer Dooren, on today's news. FDA requires pretty stern warnings on Foradil, as it is, but it did stop short of saying it was unsafe in all cases. Here's a taste:
. . . .The U.S. Food and Drug Administration said it plans to implement new "safety controls" for a class of long-acting asthma drugs, largely by adding tougher warnings about the proper use of the drugs to the product labels.
The changes affect. . . Foradil, which is marketed in the U.S. by Merck & Co. . . . The FDA said the drugs should only be used for the shortest time possible "to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved." Patients should then be maintained on another asthma controller. . . .
Top FDA officials said they wanted to see the overall use of the products reduced, saying they are only needed by the sickest of asthma patients. . . .
In December 2008, an FDA advisory panel said the risks of two asthma drugs outweighed the benefits of their usage by children and adults.
The panel said the risks of. . . Foradil were greater than the benefits of the drugs as maintenance treatments. However, the panel stopped short of recommending the drugs not be used at all. . . .
Ouch -- Foradil (my December 2008 backgrounder, here): one more headache Merck acquired from Fred Hassan and Carrie Cox.
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