Dosing instructions for children's Tylenol and other products containing acetaminophen should be added for those under age two, a U.S. advisory panel unanimously recommended.
The goals are to provide specific instructions for parents and caregivers to relieve pain and fever in children while minimizing the risk of an overdose of acetaminophen.
Currently, the instructions for children's pain and fever relievers are based on an age range and only sometimes include dosing by weight, which is considered more accurate. Panellists said the instructions should stress weight as the preferred approach to use when giving children the medicine.
The U.S. Food and Drug Administration's panel of advisers voted 21-0 on Wednesday in favour of adding doses by weight for children six months to two years old for over-the-counter acetaminophen formulas.
Now, labels on such products in the U.S. also direct people to "ask a doctor" for guidance.
That's because for babies under six months, fever can be associated with dangerous infections like meningitis and pneumonia.
Acetaminophen is a common overdose in children under two and have been increasing over the past decade, according to the FDA. The drug is also a leading cause of liver failure when recommended doses are exceeded.
The Consumer Healthcare Products Association said in a statement following the decision that it supported the recommendations to "give parents and caregivers more accurate and detailed dosing information where it is needed — directly on the drug facts label."
On Tuesday, the group presented voluntary steps that members such as Johnson & Johnson, Novartis, GlaxoSmithKline have taken.
The steps include:
- Voluntarily eliminating infant drops of acetaminophen drugs.
- Converting all single-ingredient liquid acetaminophen products for children to a single concentration (160 mg/5 mL), starting in mid-2011.
- Standardizing all dosing devices with consistent and easily visible measurement markings as well as standardizing the unit of measurement to "mL" on dosing charts and devices.
The FDA is not required to follow the advice of its advisory panels but often does.
In Canada, the concentration of acetaminophen and dosing directions for pediatric products is regulated by Health Canada. The labelling standard governing these products in Canada was updated in late 2009.