Word: acetaminophen
(lookup in dictionary)
(lookup stats)
Dates: all
Sort By: most recent first
(reverse)
...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...
...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...
...That's what the committee's conclusions represent - a strong message that as safe as acetaminophen is, it can be made safer, to help people avoid accidental overdoses. McNeil Consumer Healthcare, Tylenol's manufacturer, disagrees, citing 150 clinical studies on the drug's safety if taken as recommended. In a statement, the company said, "McNeil Consumer Healthcare strongly disagrees with the committee's recommendation. McNeil Consumer Healthcare believes that this recommendation is likely to lead to more serious adverse events as consumers shift to other over-the-counter products ... in search of pain relief." (See the most common hospital mishaps...
...There's no guarantee that the FDA will actually follow the advisory committee's advice and reduce the over-the-counter dose of acetaminophen. And even if the agency does, some experts aren't convinced that the move will lead to fewer liver toxicities associated with the medication. "Honestly, I don't think that is going to solve the problem," says Ruha. "Most of the problem is with the prescription pain medications that contain acetaminophen." Many people using drugs such as Vicodin or Percocet still don't feel relief from their pain and either abuse their prescription or supplement with...