FDA Restricts Drugs with High Doses of Acetaminophen
In January 2011, the FDA requested that manufacturers limit drug products containing acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. FDA held true to the request and will soon withdraw approval for any medications containing more than 325 mg of acetaminophen.
On January 14, 2014, the FDA issued a statement “recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit.” The FDA provided that there is no data indicating that taking more than 325 mg of acetaminophen provides any benefit that would outweigh the added risks for liver injury associated with the drug. Further, the FDA stated that “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.”
Acetaminophen is a common medication for relieving mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and to reduce fever. The FDA issued a consumer update providing that many prescription and over-the-counter medications contain the active ingredient acetaminophen.
USA Today reports that the FDA presented statistics indicating that overdoses from acetaminophen send 56,000 people to emergency rooms annually, and such overdoses result in about 500 deaths per year as well.
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