The Food and Drug Administration is asking doctors to stop
prescribing combination medications that contain more than 325
milligrams of acetaminophen per pill, because of long-standing concerns
about liver damage.
The move, announced Tuesday, is one of a
series of actions the FDA is taking to limit high-dose use of the
popular painkiller. FDA already has asked drug-makers to stop producing
combination prescription medications with higher doses. More than half
of manufacturers have complied, according to the FDA statement.
products typically combine acetaminophen with opioid painkillers, such
as hydrocodone and codeine, and are commonly prescribed after injuries,
surgeries and dental procedures.
The agency says it soon will
withdraw approval for any of those medications containing more than 325
mg of acetaminophen. It also said that it is planning new regulations
on over-the-counter acetaminophen, but did not give details.
non-prescription painkillers, such as Extra Strength Tylenol, contain
500 mg of acetaminophen in each pill. Tylenol's maker Johnson &
Johnson recently announced it was adding warning labels to bottle caps to remind consumers to read the label for dosing and safety instructions.
the new statement, FDA said: "There are no available data to show that
taking more than 325 mg of acetaminophen per dosage unit provides
additional benefit that outweighs the added risks for liver injury.
Further, limiting the amount of acetaminophen per dosage unit will
reduce the risk of severe liver injury from inadvertent acetaminophen
overdose, which can lead to liver failure, liver transplant, and death."
FDA says it's OK for doctors to prescribe two-pill doses, for a total dose of 650 mg, when that's medically appropriate.
from acetaminophen send 56,000 people to emergency rooms and kill about
500 each year, according to FDA. The drug is a leading cause of acute
FDA has previously said that most cases of liver
damage occur in patients who take more than the maximum recommended dose
of 4,000 mg in 24 hours.