• Cold medicine in children carries risks, FDA advises

    October 2007 

    The Food and Drug Administration (FDA) began reviewing the safety and effectiveness of over-the-counter (OTC) cough and cold medicine for children in March 2007.

    In mid-August 2007, the FDA warned parents to not give children age 2 or younger OTC cough and cold medicine unless specifically instructed to do so.

    The FDA began review of children’s cough and cold medicines after questions were raised about the safety of these products for children, particularly in children under the age of 2. It is still unclear whether the benefits of these medications outweigh any potential risks. Some research finds that medications are safe to use when the package indications are followed, while other research suggests cough and cold medicines are not effective in children and should not be used.

    What did the FDA advisory include?

    The FDA public health advisory issued in August recommends the following to parents using OTC cough and cold medicine in children:

    • 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.
    • Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called “pediatric” use).
    • Cough and cold medicines come in several 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 and follow directions in the “Drug Facts” box on the package label so that you know the active ingredients and the warnings.

    Adverse effects in children

    OTC cough and cold products are widely marketed and used by parents to treat children with symptoms of the common cold. They are available as either single ingredients or more often as combination products containing one or more of the following: nasal decongestant, expectorant, antihistamine, cough suppressant, analgesic and fever reducer. Although these products have been in use in children for many years, the FDA notes the scientific data supporting use in children are limited.

    In January 2007, the Centers for Disease Control and Prevention published a report describing three infants, all less than 1 year old, who died after use of cough and cold products. It also reported an estimated 1,519 children younger than 2 were treated for adverse events from such medications during 2004 and 2005.

    In February 2007, the FDA completed an internal review of serious and life-threatening side effects in children younger than 6 years. From 1969 through the fall of 2006, there were 54 reported deaths just with decongestants and 69 with antihistamines, the majority in children younger than 2 years of age. Since adverse-event reporting was not required and usage is not reported, the FDA concluded “we have no way of definitely knowing how many fatalities occurred in relation to the number of children given cough and cold products during this time, nor whether the medicine was really the only problem.

    Several of the serious adverse effects reported with the use of OTC cough and cold medicine appear to be the result of overdosing children. An overdose can be caused by giving more than the recommended amount, giving the recommended amount too often, or from combining medicines with the same active ingredient.

    Infection vs. a cold: When to give medication

    Colds are considered a minor infection of the nose and throat caused by one of more than 250 different types of cold viruses. Children, on average, get six to eight colds a year, with the most colds occurring from September to April. Cold symptoms often appear gradually and may include a runny nose, congestion, sneezing, scratchy throat or a cough.

    The FDA cautions parents to remember that cough and cold medicines only treat symptoms of a cold. The medicine cannot cure a cold; children will get better with time. A child with a viral illness, such as a cold, should be noticeably better in about three days. After five days, the child should be almost well. A fever in the first 24 hours is normal, but if a fever starts after a few days, it may be a sign of a secondary infection and a trip to the doctor may be in order.  






    fever reducer, aches, pains

    Motrin or Advil


    aches, pains

    Triaminic Night Time






    Vick's DM


    cough suppressant




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Page last updated: 8/7/2015 2:14:51 PM
  • What the news means for you

    Use care in treating child's colds

    Carol Steltenkamp, MD

    Wright, Heather, MDThe FDA advisory was issued for children because cough and cold medicines affect children differently than adults. Drugs have the potential to build up in children because they may not have the ability to clear the medication as quickly.

    “I never recommend giving cough and cold medicine to a child under 6 months and rarely in children age 6-24 months.” 

    There is just not enough research out there on children to tell for certain how some medications affect them. The United States doesn’t require clinical trials on a drug’s effects on children, trials only test adults. As a result, dosage is based on weight for children, making it difficult to have a standardized dosage. For example, not all 2-year-olds are the same size and weight.

    If your child is under the age of 6, it is important to talk with your doctor about correct dosage. Even though it is over-the-counter medication, adverse effects can occur if dosage instructions are not followed.

    Risks and benefits

    The American Academy of Pediatrics recommends never giving cough and cold medication to children under age 6 months.

    The FDA says giving the recommended amount of cough and cold medicine to children age 2 and older is fine. Once children are age 6 or older, medication is reasonable in most instances but not in all. There is evidence that both supports giving cough and cold medicine to children and evidence that does not support it. If you are treating a cold, it will get better with time without medication. I recommend for parents to consider giving their children age 2 and older cough and cold medicines for two to three days for some symptomatic care. I never recommend giving cough and cold medicine to a child under 6 months and rarely in children age 6-24 months.

    “I typically recommend patients avoid the multi-medication drugs. It is best to treat the child’s specific symptoms.” 

    Home remedies for a cold

    There are some great options for parents who want to make their children more comfortable during a cold but wish to avoid cough and cold medicine. If your child’s cold symptoms are not interfering with daily activity or sleep, try some of the following methods:

    • Encourage lots of liquids - water, juice, milk.
    • A vaporizer/humidifier to reduce congestion (Clean it out every day).
    • Nasal suction to remove mucus.
    • Steam.
    • Salt-water nose drops (1/4 teaspoon salt in 1 cup water).

    Reading the package label

    It is important to read the package label carefully and know what the active drugs are in each medication. Learn the generic name as well as the brand name so you can recognize what active ingredients are in a brand name medication. For instance, acetaminophen is the generic name for Tylenol; it can be beneficial to treat aches, pains and a fever. There is acetaminophen in some multisymptom medications such as NyQuil, but typically not enough to bring down a fever.

    You don’t want to give your child both Tylenol and NyQuil because they both contain acetaminophen. I typically recommend patients avoid the multi-medication drugs. It is best to treat the child’s specific symptoms. For example, if your child has a cough but no nasal congestion, then a cough suppressant would be better than a multisymptom medication.

    Remember, you cannot cure a cold with antibiotics or cough and cold medicine. Colds are only cured by time. Medication is used purely to treat symptoms and to make your child more comfortable during a cold.

    Dr. Steltenkamp practices general pediatrics at Kentucky Children’s Hospital and the Twilight Children’s Clinic, in addition to being an associate professor of pediatrics at UK College of Medicine.

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