American Academy of Family Physicians

Printer-friendly version

Share this on AAFP Connection

Share this page

FDA Advisory

Warn Parents About Dangers Cold Medicines Pose for Kids

By News Staff

Family physicians should alert the parents of their younger patients that the FDA has issued a public health advisory regarding the use of over-the-counter, or OTC, cough and cold medications for children.

stock photo
"Do not use cough and cold products in children under 2 years of age, unless given specific directions to do so by a health care provider," the advisory says. "Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger."

The Aug. 15 advisory tells parents to use only products marked for use in babies, infants and children. Such products are sometimes packaged as pediatric formulas.

In addition, the advisory offers some advice.
  • "Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a health care provider.
  • "If other medicines (OTC or prescription) are being given to a child, the child's health care provider should review and approve their combined use.
  • "Read all of the information in the 'Drug Facts' box on the package label so that you know the active ingredients and the warnings.
  • "Follow the directions in the 'Drug Facts' box. Do not give a child medicine more often or in greater amounts than is stated on the package. …
  • "For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children. …
  • "If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device, … DO NOT USE the medicine. Consult your health care provider if you have questions or are confused."
The advisory reminds parents that cough and cold medicines only treat cold symptoms and do not cure colds. It also recommends that if a child's condition worsens or fails to improve with time, parents should take the child to a health care professional for evaluation.

"Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children," the advisory says.

Neurological problems, such as seizures and loss of consciousness, have been attributed to dextromethorphan -- an ingredient often included in cold medications -- and pseudoephedrine, another common ingredient, has been associated with infant deaths, increased blood pressure and arrhythmias.

The FDA will convene its Nonprescription Drugs Advisory Committee and its Pediatric Advisory Committee Oct. 18-19 to discuss the safety and effectiveness of cough and cold medicines.

Share this on AAFP Connection

Health of the Public

Study: PPI Does Not Routinely Improve Asthma Control

Recalled Oral Contraceptives Pose Pregnancy Risk

CDC to Fund 2D Vaccine Barcoding Pilot

2012 Immunization Schedules Reflect Multiple Changes

Study: Cognitive Decline Detected in Middle-aged Adults

CDC Toolkit Can Help Clinicians Fight Norovirus Infection

Patient-Centered Care Linked to Lower Mortality

Study: Inappropriate Cancer Screenings Continue

Novartis Manufacturing Plant Closes After Drug Mix-ups

FDA Announces Classwide REMS for TIRF Medications

New Infants' Acetaminophen Products Hit Store Shelves

Avoid Environmental Factors Linked to Breast Cancer

Risk for Thrombosis Prompts REMS for Rivaroxaban

Common Drugs Implicated in Most Emergency Hospitalizations

CDC Launches Campaign for Child Medication Safety

HHS Blocks Expanded OTC Access to Plan B

Push Is On to Vaccinate Pregnant, Postpartum Women

FDA Committee Votes to Broaden PCV13 Indication

AAFP Foundation Program Aims to Fight Chronic Disease

NIAAA Alcohol Screening Guide Targets Teens

Walgreens, AAFP Launch Flu Vaccine Pilot in Five States

Helping Patients Quit Smoking Starts With a Question

Trilipix Efficacy in Question, Says FDA

USPSTF Addresses Skin Cancer, Obesity, Cervical Cancer Screening

AAFP Endorses ACP Guideline on ED

ACIP Recommends Expanded HPV, Hepatitis B Vaccination

Bacterial Contamination Spurs Nasal Spray Recall

CDC Renews Call for PCV13 Vaccination

USPSTF Recommends Against PSA Screening

AAFP Supports HHS' Million Hearts Initiative

FDA Phases Out Primatene Mist Inhalers

AHRQ Guides Explain Benefits, Risks of GERD Treatments

Tar Wars Winner Gives Back

Office Champions Project Nets Smoking Cessation Gains

Multiple Lots of Oral Contraceptives Recalled

New Vaccine Review Finds Few Adverse Events

HPV Vaccination Rates Still Lag, Says CDC

Renal Injury Prompts Reclast Label Changes

High-dose Citalopram Linked to Abnormal Heart Rhythms

AHRQ Sleep Apnea Guides Review Diagnosis, Management

Board Chair Spotlights Breadth of Family Medicine Training

USPSTF Softens Stance on Bladder Cancer Screening

HHS Expands Coverage for Women's Preventive Services

Teledermatology Project Aids Underserved Patients

New Chantix Warnings Cite Cardiovascular Risk

Pertussis Outbreaks Lead to CDC Alert on PCR Testing