What's New in Cough and Cold Medications for Kids?
Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.
Statistics reveal that an estimated 95 million packages of cough and cold medications are purchased each year for use in children,1 and with the FDA advisory issued earlier this year on the use of these products in the pediatric population, many parents and caregivers will be seeking advice from their pharmacist.
Last fall the FDA assembled a joint meeting of the Pediatric Committee and the Nonprescription Drug Advisory Committee, and this advisory panel issued recommendations on the use of cough and cold preparations in children under 6 years of age. The panel's recommendations were based on results from multiple studies that reported a lack of effectiveness regarding pediatric cold medications and risks of potential adverse effects, especially in children younger than 2 years of age.2,3 Serious adverse effects have been associated with accidental overdose, unintentional misuse, and drug?drug interactions in children given standard doses.1 The panel reviewed the following categories of drugs:
- Cough expectorants
- Cough suppressants
FDA Advice on the Use of Cough and Cold Products (Aged 2 to 11 years)
Pending completion of the FDA?s ongoing review, parents and caregivers who choose to administer OTC cough and cold medicines to children aged 2 to 11 years should:
- Follow the dosing directions on the label of any OTC medication
- Understand that these drugs will not cure or shorten the duration of the common cold
- Check the Drug Facts label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients
- Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs
- The FDA recommends that anyone with questions contact a physician, pharmacist, or other health care professional to discuss how to treat a child with a cough or cold
Adapted from reference 4.
Although many medical experts may agree that the risks from pediatric cough and cold medications may be low, some experts still feel the recommendations are needed.2 On January 17, 2008, the FDA issued a public health advisory recommending that OTC cough and cold products not be used in children under 2 years of age because serious adverse effects can occur.4 The FDA also is working to complete a review on the safety of OTC cough and cold medications in children aged 2 to 11 years and plans to issue a recommendation on the use of these products in this age group once that review is completed.4 The box at right lists the FDA's current advice for children aged 2 to 11 years.
Prior to the FDA panel's recommendations, the Consumer Healthcare Products Association (CHPA) issued a press release in October stating that a number of major manufacturers voluntarily agreed to discontinue the marketing of cough and cold products for children under 2 years of age.5 The CHPA Education Foundation has a Web site (www.otcsafety.org/Parents) for parents seeking information on the use of these medicines in children.
In addition, to assist parents and caregivers in managing colds in children, the American Academy of Pediatrics recommends the following6:
- Administer acetaminophen or ibuprofen (not aspirin) if fever is present
- Ensure adequate hydration
- Use a cool mist humidifier to relieve nasal passages
- Administer saline nose drops to thin mucus
- Use a suction bulb in babies to clear mucus
Given these new guidelines for the use of cough and cold products in children, pharmacists should seize every opportunity to ensure that parents and caregivers are counseled effectively about the appropriate use of these medications.
- Sharfstein, JM, North, M, and Serwint, JR. Over the counter but no longer under the radar-pediatric cough and cold medications. N Engl J Med. 2007;357:2321-2324.
- Nonprescription Drug Advisory Committee Meeting. FDA Web site. www.fda.gov/~2007-4323b1-02-FDA.pdf.
- Kid's Cold Medicines: New Guidelines. WebMD Web site. www.webmd.com/a-to-z-guides/kids-cold-medicines-new-guidelines.
- FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products [press release]. FDA Web site. www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html.
- Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines [press release]. Consumer Healthcare Products Web site. www.chpa-info.org/~2007/10_11_07_CCMedicines.htm.
- Childhood Infections. American Pediatric Association Web site. www.aap.org/publiced/BR_Infections.htm.
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The American Dietetic Association recently joined 3 other groups in filing a joint citizen?s petition to the FDA regarding weight-loss claims made by the marketers of dietary supplement?containing aids. The groups want the agency to make changes in the regulation of weight-loss supplements so the manufacturers would be mandated, on the basis of valid scientific evidence, to have prior FDA approval of weight-loss claims. Normally, regulating weight-loss claims made in advertising has fallen under the Federal Trade Commission (FTC). The citizen?s petition argues that if the FDA ruled in favor that weight-loss claims are a disease state claim, the FTC would no longer have regulating authority.
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