Over-the-counter medicine makers have changed labels on oral OTC children's cough and cold medicines to reflect voluntary updates. In light of these changes, the Consumer Healthcare Products Association (CHPA) has developed the following “Frequently Asked Questions” document to provide the facts about these medicines.
- Are children’s oral OTC cough and cold medicines safe?
- Why did you change the labels?
- Will these still be available for use in children?
- What do the updated labels say?
- What action has FDA taken to date regarding oral pediatric cough and cold medications?
- Specifically, which medicines are being discussed?
- Why were some of these medicines voluntarily withdrawn from the market in October 2007?
- In light of all of this, why should parents trust these medicines?
- Do these medicines work?
- Should all children’s oral cough and cold medicines be withdrawn from the market?
- What are the makers of these medicines doing to address misuse?
- What are other countries doing about oral pediatric OTC cough and cold medicines?
- Are children’s oral OTC cough and cold medicines safe?
Yes. Children’s OTC oral cough and cold medicines are safe and effective when given as directed. Although problems with these medicines are very rare and mostly related to incorrect dosing and curious, young children getting into medicines, manufacturers have changed labels for children under age 4. Adult cough and cold medicines were not part of this label update.
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- Why did you change the labels?
Medicine makers voluntarily made updates to the labels based on consultations with the U.S. Food and Drug Administration. Although adverse events related to cough and cold medicines are rare and most often occur in children under age two, we voluntarily changed our labels to help encourage the appropriate use of these medicines. Adult cough and cold medicines are not part of these label updates.
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- Will these still be available for use in children?
Yes, these OTC oral pediatric cough and cold medicines are still available to help relieve children’s cough and cold symptoms.
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- What do the updated labels say?
The medications themselves are the same medicines you’ve relied on for years when caring for your children, but they now have labels that advise parents and caregivers not to use them for children under age 4. In addition, oral OTC cough and cold medicines containing antihistamines (which are clearly labeled with that word in the “uses” section of the Drug Facts label) carry a warning: Do not use to sedate or make a child sleepy.
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- What action has FDA taken to date regarding oral pediatric cough and cold medications?
On October 18 and 19, 2007, an FDA advisory committee discussed the safety and efficacy of OTC cough and cold medicines for children. Adult cough and cold medicines were not part of this examination.
The panel, in a split vote of 13-9, voted to recommend to FDA that oral OTC cough and cold active ingredients should no longer be available for use in children under six years of age. This recommendation was limited to symptoms of the common cold and did not include, for example, expectorants for cough or antihistamines for allergy.
On January 17, 2008, FDA issued a public health advisory instructing parents not to use oral pediatric cough and cold medicines in children under the age of two. The agency also concurred with the industry’s request to add label language telling parents not to use these products to sedate children.
On October 2, 2008, FDA held a public meeting to gather more information on the regulatory process for pediatric cough and cold medicines and on the issue of scientific testing in children. Adult cough and cold medicines are not included in this process. FDA has said that adverse events associated with pediatric cough and cold medicines are rare, but the science-based agency also recognizes that there are limited medical trials available upon which to make an ultimate determination about any changes to the monograph. The October meeting was intended to help provide the FDA with more data specific to pediatric populations upon which to make this risk-benefit analysis to confirm the correct dosing and safe use of these products. CHPA and its members participated in the meeting and presented information about the industry's comprehensive research agenda, as well as an overview of the public education campaign to make sure parents and caregivers understand how to safely give and safely store oral pediatric cough and cold medicines. More information about safe OTC medicine use can be found at OTCsafety.org.
While FDA has indicated it has not made an official decision, medicine makers voluntarily updated oral pediatric cough and cold medicine labels based on consultations with senior officials with the agency.
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- Specifically, which medicines are being discussed?
FDA’s advisory committee focused on children’s oral OTC cough and cold medicines, including antitussives, expectorants, nasal decongestants, antihistamines, and combination cough and cold medicines. These medicines contain the following active ingredient(s): brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine. Adult medications containing these ingredients are not part of this examination.
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- Why were some of these medicines voluntarily withdrawn from the market in October 2007?
Oral cough and cold medicines are safe and effective when used as directed, and the large majority of parents use these medicines safely. The makers of these medicines voluntarily withdrew of oral, infant cough and cold medicines specifically intended for infants because of reports associated with rare instances of misuse, especially in children under two years of age. It was out of an abundance of caution that we decided to implement the change in advance of FDA’s advisory committee meeting in an effort to provide parents and caregivers with the most timely and accurate information available.
In January 2008, FDA made an official announcement against the use of oral, OTC cough and cold medicines in children under two. This recommendation reaffirmed the October 2007 action by industry to voluntarily withdraw infant, oral cough and cold medicines.
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- In light of all of this, why should parents trust these medicines?
Under the current monograph, established by FDA’s OTC Drug Review, FDA has determined that these medicines are generally recognized as safe and effective when used according to their labels. These medications have been effectively treating the symptoms of colds for decades – and billions of doses have been safely used.
Additionally, millions of moms and dads rely on these medicines to help their children feel better faster. In fact, in a recent survey conducted by CHPA, 76 percent of all parents surveyed said they found these medicines effective in helping to relieve cough and cold symptoms.
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- Do these medicines work?
Yes. While these medicines do not cure or treat conditions themselves, they play an important role in reducing symptoms associated with the common cold (nasal congestion, runny nose, and coughs). Until FDA makes any further determinations, the current monograph holds OTC cough and cold medicines to be safe and effective.
As science has evolved, we now have better tools to confirm the doses for these medicines in children under 12 years of age. The makers of these medicines have committed to working with FDA to reaffirm the efficacy and appropriate dosing of these medicines in children.
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- Should all children’s oral cough and cold medicines be withdrawn from the market?
No. These medicines are generally recognized as safe and effective by FDA, and have been relied upon for decades. Issues raised at FDA's October 2007 advisory committee meeting are not about product safety. Adverse events associated with these trusted medicines are rare and are predominantly a result of misuse or unsupervised ingestion. Following consultations with the FDA, the nation’s medicine makers made voluntary updates to oral children's cough and cold medicines.
Because we recognize that FDA’s formal regulatory processes can take a long time to complete, the leading manufacturers of oral OTC pediatric cough and cold medicines, through ongoing discussions with FDA, are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines. Visit OTCsafety.org for more information.
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- What are the makers of these medicines doing to address misuse?
Oral pediatric cough and cold medicines have a long track record of safe and effective use, and we want to help all parents and caregivers use them correctly. Because reports of rare instances of accidental ingestion or misuse, CHPA and the makers of these medicines are engaged in a major, multi-year campaign aimed at providing parents and caregivers with the necessary tools they need to safely store and appropriately administer these medicines to children. Concurrent to this outreach among parents, CHPA is working with the medical community to encourage more direct communication on symptoms and treatment options for children. In addition, CHPA members have committed to ensuring all oral pediatric cough and cold medicines will be in child-resistant packaging.
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- What are other countries doing about oral pediatric OTC cough and cold medicines?
Every nation’s drug regulatory body has the authority to make individualized decisions about how to label its medications. In the United States, FDA is in charge of this decision-making process. U.S. drug makers have voluntarily changed the labels of their oral pediatric cough and cold medicines, based on discussions with the FDA.
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