Photo Credit CDC
# 6841
With influenza-like-illness activity climbing across much North America, today is probably a good time to revisit some of the dangers of using over-the-counter (OTC) `cold’ remedies, particularly on young children.
In January of 2008 the FDA issued a warning to parents that OTC cough and cold remedies were no longer considered to be safe or effective for children under the age of 2.
Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age
FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age. FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.
Despite this announcement, the debate over the safety and effectiveness of these same medications for older children continued, with some experts calling to ban their use for children under the age of 6.
In a bit of a pre-emptive strike, in the fall of 2008 the CHPA (Consumer Healthcare Products Association ) announced that its members were voluntarily modifying the product labels on many of their OTC meds to state "do not use" in children under 4 years of age.
Despite these recommendations, and the publicity they generated, old habits die hard. Many young parents (and not-so-young grandparents) fall back to using the same remedies and OTC meds they used a generation or two ago.
Granted, watching a child suffering from a cold or flu can be very difficult, and so there is a strong impulse to `do something’.
But all medicines . . . even those available over-the-counter – have risks. And for very small children, the FDA and the CDC believe those risks outweigh any benefit they might derive from these types of products.
Increasingly, accidental overdose from OTC medications among young children is becoming a serious health issue. To try to reduce those numbers, the PROTECT Initiative was formed.
The PROTECT Initiative: Advancing Children’s Medication Safety
What is PROTECT?
The PROTECT Initiative is an innovative collaboration bringing together public health agencies, private sector companies, professional organizations, consumer/patient advocates, and academic experts to develop strategies to keep children safe from unintentional medication overdoses. Medication overdoses can lead to harm, sometimes requiring emergency treatment or hospitalization and are a significant public health problem.
Why PROTECT?
Over-the-counter (OTC) and prescription medications are commonly used for people of all ages. This frequency of use increases the potential for unintentional (accidental) overdoses. Children are especially vulnerable to unintentional overdoses, most of which can be prevented. Data from the National Electronic Injury Surveillance System-Cooperative Adverse Event Surveillance System (NEISS-CADES) project estimated that each year in the United States:
- Over 70,000 emergency department (ED) visits result from unintentional medication overdoses among children under the age of 18 [1];
- One out of every 151 two-year-olds is treated in an ED for an unintentional medication overdose [2];
- Over 80% of ED visits among children under the age of 12 are due to unsupervised children taking medications on their own and 10% of ED visits in this age group are due to medication errors [1];
- Over-the-counter medications are involved in approximately one-third of ED visits among children under the age of 12 [1].
If most OTC medications are off the table for young children, you may be asking what the CDC recommends:
My child has the flu, how do I care for him or her?
If your child has flu-like symptoms and he or she is younger than 5 years old or has any chronic medical conditions, contact a health care provider as soon as possible. Your child’s provider may want to prescribe antiviral medications to make your child’s symptoms less severe and help him or her feel better faster.
On December 21, 2012, the U.S. Food and Drug Administration expanded the approved use of Tamiflu to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days. Tamiflu is the only product approved to treat flu infection in children younger than 1 year old.
Follow these special instructions, in addition to the recommendations in Caring for Someone with the Flu, when caring for children and infants with the flu:
- Do not give aspirin (acetylsalicylic acid) to children or teenagers who have the flu. Giving aspirin to children with the flu can cause a rare but serious illness called Reye’s syndrome. Read ingredient labels on over-the-counter medications carefully to ensure they do not contain aspirin.
- To safely treat children under 2, use a suction bulb to help clear mucus and a cool-mist humidifier to make breathing easier.
- Do not give children younger than 4 over-the-counter cold medicines without consulting a health care provider.
- Give children and teens 5 years and older cold medicines with acetaminophen (Tylenol®) or ibuprofen (Advil®, Motrin®, Nuprin®), to relieve symptoms.
Adding to the risks of OTC meds, in December of 2010 we saw a study (see JAMA: Inconsistent Dosing Instructions For OTC Meds) demonstrating the sometimes dangerously ambiguous labeling of measuring devices, and inconsistent instructions, on many cough and cold medicines.
And in August of 2010 (see Inappropriate Use Of OTC Medicines In Children) a study was presented at the International Pharmaceutical Federation’s (FIP) conference in Lisbon, Portugal (Aug 28th-Sept 2nd), on the widespread parental misuse of over-the-counter (OTC) medicines for children.
And for children and adults, it is important to know that many cold remedies contain acetaminophen, and that taking too much can cause serious (even fatal) liver damage (See The Narrow Margin).
In October the AAC (Acetaminophen Awareness Coalition) launched a Know Your Dose campaign to help educate consumers about the safe use of the popular pain reliever.
Credit – Acetaminophen Awareness Coalition
For more on how to feel better safely (regardless of age) when you have a cold or Flu, the CDC recommends:
Symptom Relief
