CAM and OTC Medication

An estimated 31% to 84% of children with cancer, 74% with autism spectrum disorder, 71% with asthma, and 15% seen in the emergency department utilize CAM or

other OTC products. Over 50% of parents/caregivers do not disclose this use to the physicians.35 CAM can include mind-body therapy (e.g., imagery, hypnosis), energy field therapies (e.g., acupuncture, acupressure), massage, antioxidants (e.g., vitamins C and E), herbs (e.g., St. John's wort, kava, ginger, valerian), prayer, immune modulators (e.g., echinacea), or other folk/home remedies.

It is critical to realize that there are limited data establishing efficacy of various CAM therapies in children. For example, colic is a condition of unclear etiology in which an infant cries inconsolably for over a few hours in a 24-hour period, usually during the same time of day. Symptoms of excessive crying usually improve by the third month of life and often resolve by 9 months of age. No medication has been approved by the FDA for this condition. This condition is self-limiting and infants will outgrow it as they age. Some parents are advised by family and friends to use alternative treatments, such as gripe water, to treat colic. Gripe water is an oral solution containing a combination of ingredients such as chamomile, peppermint, fennel, ginger, aloe, sodium bicarbonate, and lemon balm. Combinations of ingredients vary among manufacturers as there is no defined formulation. These options have not been proven safe or effective in the treatment of colic in infants and are not regulated by the FDA. Further, some of these therapies (e.g., St. John's wort) can interact with prescription drugs and produce toxicities. St. John's wort can increase adverse effects of selective serotonin receptor antagonists and 5-HT1 serotonin receptor agonists due to serotonergic syndrome and decrease effectiveness of anticonvulsants, warfarin, cyc-

losporine, digoxin, and protease inhibitors due to their increased metabolism and re-

duced serum concentration.

It is important to assess OTC product use in pediatric patients. For example, treatment of the common cold in children is similar to adults, including symptom control with adequate fluid intake, rest, use of saline nasal spray, and acetaminophen (15 mg/kg/dose every 6-8 hours) or ibuprofen (4-10 mg/kg/dose every 8 hours) for relief of discomfort and fever. Unlike adults, symptomatic relief through the use of pharmacologic agents, such as OTC combination cold remedies, is not recommended for pediatric patients younger than 4 years of age. Currently, the FDA does not recommend the use of OTC cough and cold medications (e.g., diphenhydramine and dextromethorphan) in children less than 2 years of age; however, the Consumer Healthcare Products Association, with the support of the FDA, has voluntarily changed product labeling of OTC cough and cold medications to state "do not use in children under 4 years of age." This is due to increased risk for adverse effects (e.g., excessive sedation, respiratory depression) and no docu-mented benefit in relieving symptoms. It has also been noted that these medications may also be less effective in children under 6 years of age compared with older children and adults.39,40 Also noteworthy is the potential for medication error with use of OTC products in older children, such as cold medications containing diphenhydramine and acetaminophen. A parent/caregiver may inadvertently overdose a child on one active ingredient, such as acetaminophen, by administering acetaminophen suspension for fever and an acetaminophen-containing combination product for cold symptoms. The use of aspirin in patients less than 18 years of age with viral infections is not recommended due to risk of Reye's syndrome. While making an appropriate recommendation for an OTC product for a pediatric patient, the parent/caregiver should always be referred to their pediatrician for further advice and evaluation, especially in the care of a neonate.

Clinicians should respect parents'/caregivers' beliefs in use of CAM and OTC products and encourage a discussion with the intention of providing information re garding their risks and benefits to achieve desired health outcomes as well as optimize medication safety.

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