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FDA Considers Banning Popular Prescription Pain Medications and Putting New Dose Restrictions on Over-the-Counter, Acetaminophen-Containing Drugs

As CNN reported on June 30, 2009 ("FDA Advisors Vote to Take Vicodin, Percocet Off Market"), an FDA advisory panel voted in favor of "eliminating prescription drugs that combine acetaminophin with narcotics -- such as Vicodin and Percocet -- because of their risks for overdose and severe liver injury." The panel also "advised the FDA to lower the maximum daily dose of acetaminophen in over-the-counter and prescription medications, and to address the formulations and dosing recommendations for children." Among other recommendations, the panel suggested that, if the FDA chooses not to remove the aforementioned medicines from pharmacy shelves, it could "lower the amount of acetaminophen" in drugs that combine acetaminophin and narcotic painkillers and "take some action to ensure that subscribers and patients are aware of the potential liver damage posed by taking these products." Although it typically follows advisory committee recommendations, CNN informs readers that it "is not required" to do so.

However, as Ohio newspaper the Columbus Dispatch reported on July 20, "Confusion and concern have followed news that the [FDA] is considering" the changes discussed above ("FDA Inquiry into Painkiller Perplexes Patients"). Interviews with local doctors confirm that patients should, as one physician stated, "talk to their doctors while the FDA decides what to do." However, "Many patients are nervous that tried and true drugs might go off the market, leaving them struggling to manage pain." The physicians who spoke with the Dispatch stressed that patients should not worry excessively but rather "take acetaminophen seriously, read labels, and understand that it's fine as long as it's not taken in excess." Moreover, the Dispatch's sources reached the consensus that "it would be a mistake to take Vicodin and Percocet off the market."

Sources at the FDA stated that "Changing dosing regulations on Tylenol would take years [...], and the agency is well aware of the concerns of people who rely on Percocet and Vicodin." FDA spokesperson Karen Riley suggested that "this will be a measured response [...], adding that labeling changes would be an option that could happen relatively quickly."

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