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...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...
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...
...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. (Read "The Year in Medicine 2008: From...
Will I still be able to fill my prescription for Vicodin or Percocet? Yes. While the FDA usually follows the recommendations of its advisory panels, the recommendations are not binding. Even if they were, they would not take effect without careful consideration by the FDA of patients who currently rely on these medications for pain relief. "Any change would be carefully orchestrated to ensure that people are not at risk of not having access to their pain medication," says Dr. Judith Kramer, an internist at Duke University Medical Center and a voting member of the committee...
...still get Tylenol and other nonprescription acetaminophen products? Yes. Even if the FDA follows the committee's advice about over-the-counter acetaminophen products, they will still be available, only in lower doses...