FDA advisory panelists voted yesterday to ban Percocet and Vicodin, two popular painkillers that contain acetaminophen, because of their potential to cause liver damage. Among dissenting panelists was Dr. Robert Kerns of Yale University, who disagreed with an outright ban of products that many consumers rely on to control severe pain: To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake.
ACSH staffers agree. FDA officials have been over-cautionary in the past, especially on drugs like this that can be used safely, says Stier. This is not an FDA that has been tolerant of risk.
Consumer representatives on the panel included Sidney Wolfe, an outspoken opponent of pharmaceutical companies and drugs in general. The fact that Sidney Wolfe is a consumer representative on a supposedly objective panel is very disturbing, says ACSH s Dr. Gilbert Ross. He is taking up a position that should be going to an actual consumer representative and not an activist from the country s most strident anti-pharmaceutical watchdog group.
The committee also voted against the ban of over-the-counter products such as Nyquil, which contain acetaminophen in combination with other drugs, though they voted overwhelmingly to require warnings on such products about possible liver damage. It s easier to overdose when you re on multiple drugs that might contain acetaminophen, explains Dr. Ross. Given the frequency and potential consequences of unintentional acetaminophen overdose, putting some sort of warning about dosage is a very good idea.