While not a vast franchise for New Merck, this potential FDA action is decidedly not good news. Here is the background material on it (a huge 3.9 Mb PDF file), for Tuesday's Pediatric Committee meeting.
Per Reuters' reporting, earlier this morning:
. . . .U.S. Food and Drug Administration staff said on Friday that it would recommend labeling changes for Merck's Cancidas to warn of possible liver problems in children taking the fungal infection drug.
The recommendation is contained in briefing materials to be considered by the FDA's Pediatric Advisory Committee meeting on Tuesday.
The FDA staff said their review of reported adverse events showed that in seriously ill children there were some cases of abnormal liver function tests and of liver injury. . . .
I'll keep you posted on developments out of the Advisory Committee meeting next week.
There are also two FDA staff pediatric review packets -- for Zetia and Vytorin (no surprises, there!), in children -- I am reviewing now. More later.
UPDATE: Matt Herper now has this out (in Tweet-blog fashion!), over at Forbes -- among other cogent Cancidas observations -- do go read all of his, but here is a snippet:
. . . .This points to a couple concerns. First, the old doctor's chestnut is to wait five years after a drug launches before taking it unless you really need it. Even that wouldn't catch this. The second is a reminder that the current system of catching drug side effects isn't very effective, because it relies on doctors and patients to report side effects. New systems that use insurer databases or electronic medical records could improve things significantly. Five years after Vioxx, we're still sorting through these issues. -- Matthew Herper. . . .