FDA Warns That Large Acetaminophen Doses May Lead To Severe Liver Damage
ByThe Food and Drug Administration is warning against large doses of acetaminophen in prescription combination drugs, citing the risk of liver damage, Fox News reported.
To reduce the risk of severe liver injury or death, the federal agency released a statement Tuesday recommending that health professionals discontinue prescribing and dispensing prescription drug products that contain more than 325 milligrams of acetaminophen per tablet or other dosage unit.
Acetaminophen is often used in combination with pain killers like oxycodone, hydrocodone, and codeine. These products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.
"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," the FDA said in a statement Tuesday.
Many consumers are often unaware that many prescription or over-the-counter drugs contain acetaminophen, making it easy to accidently overdose.
The FDA said cases of liver injury have occurred in patients who inadvertently overdosed on acetaminophen by taking more than one combination products that contain the drug, took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period and drank alcohol while taking acetaminophen.
Back in Jan. 2011, the agency asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by Jan. 14, 2014, to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen.
Although more than half of manufacturers voluntarily complied with the request, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available.
The FDA plans to withdraw the approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.