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...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...

Author: /time Magazine | Title: The FDA and Painkillers: What's Safe Now? | 7/3/2009 | See Source »

...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...

Author: /time Magazine | Title: The FDA and Painkillers: What's Safe Now? | 7/3/2009 | See Source »

...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...

Author: /time Magazine | Title: The FDA and Painkillers: What's Safe Now? | 7/3/2009 | See Source »

Should I switch from Tylenol to aspirin or ibuprofen? Not necessarily. If you are not taking any other prescription pain medications that contain acetaminophen and you take Tylenol as directed, you should not be at risk of damaging your liver. Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are effective pain relievers, but when taken at high doses and for prolonged periods - especially for the treatment of chronic pain in older adults - they carry a risk of stomach ulcers and gastrointestinal bleeding. NSAIDs may also raise blood pressure and affect kidney function. If you are concerned about your acetaminophen...

Author: /time Magazine | Title: The FDA and Painkillers: What's Safe Now? | 7/3/2009 | See Source »

...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...

Author: /time Magazine | Title: FDA Advises Lower Dosage for Popular Painkiller | 7/1/2009 | See Source »

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