May 20, 2011

Acetaminophen is in a class of medications known as analgesics (which are pain relievers) and antipyretics (which are fever reducers). It is commonly used to relieve mild to moderate pain and to reduce fever by changing the way the body senses pain and by cooling the body. Acetaminophen is available without a prescription and is used by adults, children, and infants under 2. It is important that it be taken exactly as directed because too much acetaminophen can cause liver damage (one reason why acetaminophen made for adults should not be taken by children). Furthermore, drops made for infants are more concentrated than liquids made for older children. Once again, it is imperative that the dosing instructions be followed and that the appropriate amount of medication be taken.

Acetaminophen may be the single ingredient of the medication (such as Tylenol) or it may be in combination with other medications to treat coughs and colds. In order to avoid an overdose of acetaminophen it is important to know which of your medications contain acetaminophen and in what amounts (this is another important reason why you should let your doctor know what other prescription and over-the-counter medications you are taking when you receive a new prescription, to lessen the possibility of a drug interaction or overdose).

Acetaminophen is now in the news because a Federal Drug Administration (FDA) advisory panel has voted 21 to 0 to recommend additional dosing information be placed on labels of over-the-counter pain medications containing acetaminophen as a single ingredient (such as Children’s Tylenol) for children 6 months to 2 years. The current labeling requirements state  dosing instructions for children 2 and over but only state “ask a doctor” for children under 2. The FDA advisory panel voted unanimously that the dosing information should be based on the weight of the child, which is the more accurate manner to determine the proper dosage to be given to children. The FDA is not required to follow the recommendations of its advisory panels but it usually does. The American Academy of Pediatrics and the manufacturers of acetaminophen strongly support the recommended new dosing instructions. In 2010, there were almost 7,500 reported cases of dosing errors involving acetaminophen and children, which was about 3% of the approximately 270,000 overall cases of acetaminophen overdoses during 2010.

Interestingly, another common fever reducer, ibuprofen, already includes dosing instructions for children under 2.

Any additional information provided to patients and parents of young patients who take prescription or over-the-counter medications is a positive step in educating health care consumers. We urge the FDA to promptly follow and institute the recommendations of its advisory panel so that children under 2 are provided a greater level of protection from accidental overdose of over-the-counter pain and fever reducing medications.

If you or a loved one have suffered injuries from improper prescription or over-the-counter medications, visit our website to find medical malpractice lawyers in your local area who may investigate your possible medical malpractice claim for you. Or call us toll free 800-295-3959.