Drugmakers to End Infant Formulas of Products With
THURSDAY, May 5 (HealthDay News) -- The makers of cold and fever
medications that contain the painkiller acetaminophen said
Wednesday night that they will discontinue infant-drops versions of
the products to avoid confusion that might lead to overdoses, the
Associated Press reported.
Once production ends, later this year, the companies will sell
just one formula for all children under the age of 12. Companies
such as Johnson & Johnson currently sell infant versions of the
drugs (80 milligrams) that contain half the amount of acetaminophen
found in regular children's formulas, the news service said.
Acetaminophen is a widely used drug found in a variety of
products that helps to ease pain and reduce fever. Although it's
usually safe if used according to directions, too much can damage
the liver. Acetaminophen overdose is the leading cause of liver
failure in the United States, with more than 50,000 people
requiring emergency-room treatment each year, the
The manufacturers' announcement preceded a U.S. Food and Drug
Administration meeting scheduled for later this month, at which
time agency advisers will consider whether clearer instructions and
safety labeling are needed for products containing acetaminophen
that are marketed for children younger than 2 years of age, the
news service said.
Earlier Wednesday, the FDA issued final guidance for the
production, marketing and distribution of liquid over-the-counter
drug products that are measured and dispensed with provided devices
such as spoons, cups and droppers.
The agency developed the guidance in response to concerns about
the risk of overdoses when using liquid over-the-counter (OTC) pain
relievers, cold medicines, cough syrups and digestion aids if the
dispensing devices included with the products have markings that
are confusing, unclear or inconsistent with the dosage directions
on the label.
Among the main recommendations in the guidance:
- Dosage dispensing devices should be included with all OTC
liquid drug products that are taken by mouth.
- The dispensing devices should be marked with calibrated units
of liquid measurement (such as teaspoon, tablespoon, or milliliter)
that match the units of measurement specified on the label
directions. The devices should not have any unnecessary
- Companies should ensure that dispensing devices are used only
with the intended products.
- The measure markings on dispensing devices should be clearly
visible when the liquid product is added to the device.
"Accidental medication overdose in young children is an increasingly common, but preventable, public health problem," Dr. Karen Weiss, program director for the Center for Drug Evaluation and Research's Safe Use Initiative, said in an FDA news release.
The FDA also outlined 10 tips that should be followed by parents
and caregivers when giving medicine to an infant or child:
- Read and follow the Drug Facts label on OTC medicines.
- Know the active ingredient in the medicine.
- Use the dosing tool that comes with the medicine.
- Know the difference between a tablespoon and a teaspoon.
- Know your child's weight.
- Give the right medicine, in the right amount.
- Check the medicine three times.
- Ask your doctor, pharmacist or nurse which medicines can or
can't be used at the same time.
- Always use child-resistant caps on medicines.
- Store all medicines in a safe place.
The FDA has more about
buying and using medicines safely.
Copyright © 2011
. All rights reserved.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.