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Camphor use entails unique safety concerns
Parents may seek alternative products for upper respiratory tract infection relief as the cold season approaches.
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With the recent concerns raised about the safety and efficacy of pediatric over-the-counter cough/cold products, caregivers of children and pediatric clinicians may seek other products for relief of upper respiratory symptoms, including cough.
Products containing camphor, a topical antitussive, may be one such ingredient. Although caregivers may find relief in the safety of using a non-orally administered product for their child, camphor’s use entails unique safety concerns that are important to recognize.
Therapeutic use
Camphor, a volatile oil with a strong aromatic and medicinal odor, is approved by the FDA as a topical antitussive. Menthol, also a volatile oil, is the only other FDA-labeled topical antitussive. Camphor is approved for use in children 2 years of age and older.
How camphor functions as a topical antitussive is not well described. Vapors from topical application may stimulate sensory nerve endings in the upper respiratory tract, resulting in a local anesthetic sensation. No published data supporting the efficacy of camphor for pediatric use as an antitussive have been identified by liter- ature search.
Many OTC products are available that contain camphor. Most products are labeled for use as topical analgesics. A product with the greatest allowable camphor concentration is Campho-Phenique, labeled for use as a topical analgesic and antiseptic. This product contains 10.8% camphor. The FDA has mandated that OTC products cannot contain more than 11% camphor.
Several products containing camphor are labeled for use as a cough suppressant. These products include Vicks VapoRub, VapoSteam, and Triaminic Flowing Vapors. One of the Vicks products, Vicks BabyRub, is not labeled for use as a cough suppressant, but may be mistakenly identified for this use by some caregivers. Vicks BabyRub contains petrolatum, fragrance, aloe extract, eucalyptus oil, lavender oil and rosemary oil.
Adverse effects and toxicity
More published data on the potential for significant adverse effects and toxicity of camphor exists than for its clinical efficacy.
When ingested in a toxic amount, camphor can be fatal, and case reports of clinical toxicity, including death, in children have been reported.
An ingested dose of 1,000 mg can be fatal to a 10 kg child. This equates to 15 to 20 ml of available OTC products labeled for use as a cough suppressant (containing 5%-6% camphor). Other OTC products containing camphor for other uses (eg, topical analgesic) may contain up to 11% camphor. A recently published practice guideline from the American Association of Poison Control Centers recommends that children who have ingested doses greater than 30 mg/kg be referred to an emergency department for evaluation. Symptoms of camphor toxicity may include seizures, lethargy, ataxia, or vomiting. A review of exposure data by the American Association of Poison Control Centers revealed 10,000 cases of ingestion exposure to camphor in the United States between 1990 and 2003.
In 2006 the FDA published a warning letter on the potential dangers of Triaminic Vapor Patch, which contained camphor.
This product was recalled by the manufacturer and is no longer available. Reports of accidental ingestion of these patches, with clinical toxicity, including seizures, prompted this warning letter. The AAP has also expressed concerns over the use of camphor in children, and the potential for toxicity. This statement from the Committee on Drugs, published in 1994, recommends that camphor not be used.
With concerns recently raised about the safety and efficacy of traditional orally administered pediatric cough/cold OTC products, caregivers of children and clinicians may seek other products to use for symptoms from viral URI infection.
As evidence for the efficacy of products containing camphor are very limited, such products should probably not be recommended for use. If camphor-containing products are used, it is important that clinicians educate caregivers on the potential for significant toxicity from camphor. Products should be used only by product directions, and they should be stored safely when not in use. Clinicians should continue to rely upon treatment modalities more likely to be safe for infants and children, including nasal saline, bulb suctioning, and use of a humidifier or vaporizer.
For more information:
- Edward Bell PharmD, is a Professor of Pharmacy practice at Drake University College of Pharmacy, Blank Children’s Hospital in Des Moines, Iowa.
- Committee on Drugs. Camphor revisited: focus on toxicity. Pediatrics. 1994;94:127-8
- American Association of Poison Control Centers. Camphor poisoning: an evidence-based practice guideline for out-of-hospital management. Clin Toxicol. 2006;44:357-70
- Bar-Oz B, et al. Medications that can be fatal for a toddler with one tablet or teaspoonful, a 2004 update. Pediatric Drugs. 2004;6:123-6