The FDA and Painkillers: What's Safe Now?

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The June 30 vote by a Food and Drug Administration (FDA) advisory committee to lower the maximum dosage of over-the-counter drugs containing acetaminophen and eliminate prescription acetaminophen-combination painkillers raised questions about what changes consumers should expect in the availability of the popular drug. The commonly used pain- and fever-reliever known as Tylenol is found in several nonprescription cough and cold remedies, including NyQuil and Theraflu. Patients are also asking what potential dangers their daily use of acetaminophen may pose. TIME.com talked to members of the FDA committee as well as pain experts to sort through some of the questions.
What exactly did the panel recommend?
The FDA advisory panel, made up of scientists, doctors and consumer representatives, voted to make four major changes in the way acetaminophen is dispensed and packaged. First, it voted 21 to 6 in favor of lowering the maximum daily dose of nonprescription acetaminophen for adults, which is currently set at 4,000 mg; the panel did not specify a new maximum dosage. Second, the committee voted 24 to 13 to reduce the maximum single adult daily dose to 650 mg from the current maximum of 1,000 mg, or the equivalent of two tablets of Extra Strength Tylenol. Third, the members recommended 26 to 11 that the 1,000-mg over-the-counter dose be switched to a prescription-only status. Finally, the committee voted 20 to 17 in favor of "eliminating prescription acetaminophen combination products." (See a quick guide to the FDA.)
In a separate vote, the panel recommended 36 to 1 that if acetaminophen-containing prescription drugs stay on the market, they should carry a black-box warning, the most serious safety label for prescription medications.
Why?
The panel's recommendations were geared toward protecting consumers from potential liver damage due to unintentional overdose from the drug. According to the FDA, acetaminophen remains the leading cause of liver failure in the U.S., despite repeated government warnings. However, the majority of acetaminophen-related deaths are due to prescription drugs, not over-the-counter medications. FDA data indicate that overdoses of nonprescription cough and cold products, like NyQuil and Theraflu, occur infrequently, when patients combine these medications with other acetaminophen products, like Tylenol, and unknowingly increase their exposure to the drug. (
Did the panel recommend banning the painkillers Vicodin and Percocet?
It's unclear. The wording of the question on which the members were asked to vote ("Do you recommend eliminating prescription acetaminophen combination products?") can be interpreted in two ways. A yes vote could indicate elimination of the product altogether, but it could also indicate elimination only of the pairing of acetaminophen and a narcotic (like hydrocodone or oxycodone), the other primary pain-relieving ingredient contained in Vicodin and Percocet. "The question did not specify, so conceivably panel members could have had different interpretations," says Ruth Day, director of the medical cognition laboratory at Duke University and one of the voting panel members. "However, there was a lot of other discussion about having just the main ingredient [e.g., hydrocodone] alone, so that's very likely the interpretation for everyone. And there was no call to remove the other ingredients — just take out the acetaminophen."
The committee said that if combination prescription products were not stripped of their acetaminophen component, they should at least contain less of it — no more than 325 mg. (In some combination painkillers, the dose of acetaminophen can be as high as 750 mg.)The FDA and Painkillers: What's Safe Now?Originally from: http://www.nursinglink.monster.com/news/articles/13376-the-fda-and-painkillers-whats-safe-now

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