US Pharm. 2008;33(11):12-15.
The pharmacist is on the front
lines of pharmaceutical care when patients need assistance with minor health
conditions. Quite often, parents and caregivers request assistance with
infants. The pharmacist must have an acute understanding of which products are
proven safe and effective for babies and which are not.
When the FDA began
its massive review of nonprescription products in 1972, one of the major tasks
it had to accomplish was to determine the safe ages of use for each ingredient.1
The agency sought data and eventually established the minimal safe ages for
which specific ingredients could be given and the appropriate dosages for each
age. When medications switched from prescription to nonprescription status,
the sponsor and the FDA cooperated to establish the minimum age that would be
safe for self-use.
What Is Safe for Babies?
The end result of
the FDA's deliberations is that many nonprescription products are prohibited
in children under the age of 2 years, while others are labeled against use in
patients under the ages of 3, 4, 5, 6, 12, 17, or 18 years.1 For
example, the FDA recommends that OTC cough and cold medications not be used to
treat infants and children under 2 years of age, and manufacturers have
recently announced voluntary labeling changes for those under age 4.2
Products safe for use in babies include the following: teething products,
colic products, ibuprofen concentrated infants' drops (except when used for
sore throat), ipecac syrup, sunscreens (with age restrictions), and some
nonmedicated topical products, such as those used for diaper rash. It must be
noted that many nonprescription products have never undergone scientific
scrutiny to prove their safety and efficacy, regardless of age-group.1
This includes most herbals, homeopathics, and dietary supplements. Because of
lack of knowledge regarding safety and/or efficacy in babies, these products
should be avoided.
The pharmacist can
recommend topical products for teething if the child is 4 months or older.1
As the central incisors usually do not begin to erupt until 6 to 10 months of
age, this is an appropriate age limitation. Ingredients proven safe and
effective for teething include benzocaine and phenol. Of the two, benzocaine
5% to 20% is more readily available and may be a better choice. It is found in
Baby Anbesol (7.5% benzocaine), Baby Orajel (7.5%), and Zilactin Baby Teething
Swabs (10%). Parents or caregivers should be cautioned against use of unproven
and potentially dangerous teething remedies such as homeopathic teething
tablets containing belladonna, coffee, magnets, tea tree oil, anise seed,
clove oil, and cantharides.
Some parents may ask for
assistance when the baby is experiencing fever, nasal congestion, or diarrhea.3-5
When the pharmacist recommends a physician visit, the parent may assert that
the potentially dangerous symptom is only due to teething. The pharmacist
should stress that none of those symptoms are manifestations of teething, and
the child's physician should be consulted for proper treatment.
Parents may ask for
help with a baby whose violent and prolonged crying is assumed to be due to
colic. The etiology of colic is not always clear, but some believe the
underlying cause is trapped intestinal gas.1,6 This has led to
widespread acceptance of such simethicone-containing products as Infants'
Mylicon Drops and Little Tummys Gas Relief Drops. Simethicone is nontoxic and
can be given to infants according to the doses on the label. Pharmacists
should be cautious about stocking or recommending various "gripe water"
products, such as Little Tummys Gripe Water, Baby's Bliss Gripe Water,
Wellements Gripe Water, and Gentle Care Gripe Water.7 These
unproven products contain sodium bicarbonate, ginger, fennel, and/or
chamomile, none of which is known to be safe in babies or effective for colic.
Pharmacists should neither stock nor recommend these products.
Ibuprofen Infants' Drops
concentrated infants' drops (e.g., Motrin) are approved for babies down to 6
months of age who experience minor aches and pains due to the common cold,
influenza, headaches, toothaches, teething, and immunizations.1
(The product is also indicated for sore throat but should not be used if the
patient is under the age of 3 years.) Parents should ask a physician before
using it if the child has not been drinking fluids, has lost a substantial
amount of fluid due to continued vomiting or diarrhea, has stomach pain, or
has experienced problems in the past when administered pain relievers or fever
reducers. Parents should cease using the product and immediately consult the
child's pediatrician or general practitioner if an allergic
reaction occurs, as manifested by hives, facial swelling, asthma (wheezing),
or shock. They should also seek medical help if pain or fever gets worse or
lasts more than three days, if the child does not appear to obtain any relief
within the first day (24 hours) of treatment, if stomach pain or upset worsens
or persists, if redness or swelling is present in the painful area, or if any
new symptoms appear. Before using the drops, the parent should check with the
child's physician if the child is under a physician's care for any serious
condition or is taking any other medications, including those containing
ibuprofen, other pain relievers, or fever reducers.
For many years,
ipecac syrup was considered to be a vital part of the medicine chest for every
home with an infant. Given as quickly as possible after ingestion of a
potentially toxic substance, it was allegedly useful in forcing the child to
vomit. In recent years, however, its use has become the subject of substantial
controversy. In 2003, a leading pediatric journal published research
demonstrating that use of ipecac did not affect referral to emergency
departments or the rate of adverse outcomes.8-10 Furthermore,
ipecac does not completely remove toxins from the stomach, causes adverse
effects, is mistakenly given when it should not have been, may cause
persistent vomiting, and is subject to abuse by anorexics and bulimics. As a
result of ipecac's many problems, the American Academy of Pediatrics Committee
on Injury, Violence, and Poison Control recommended against keeping it in the
home and also took the unusual step of recommending that any ipecac already
present in a household be disposed of safely. An FDA panel voted six to four
to make ipecac prescription only, but the FDA has not yet acted as of this
writing, and the drug remains available. Stocking and recommending it in light
of the current climate is not prudent. Rather, parents should be urged to call
the National Poison Hotline (800-222-1222) immediately for proper advice when
a poisoning incident occurs.
It is now general
knowledge that sunscreens are highly effective in preventing the consequences
of sun exposure when used as directed. Many parents try to place sunscreen on
infants when they are about to enter the sun. However, the FDA does not wish
to allow labeling on any sunscreen product for babies younger than 6 months.1,11
There are several reasons for this. The first is that the FDA advises parents
to keep babies less than 6 months of age out of the sun entirely. Therefore,
having a sunscreen labeled for use under that age would give parents a false
sense of security, perhaps conferring the mistaken idea that babies will be
protected if the sunscreen is used. Babies cannot voluntarily move to shade
when they are uncomfortable. They have underdeveloped sweat glands, which
increases the risk of heat prostration. In addition, their ability to
metabolize, detoxify, and eliminate the ingredients found in sunscreens is not
fully developed. However, for babies above the age of 6 months, parents should
choose a sunscreen with the highest sun protection factor (SPF) available
(i.e., SPF 50+) to minimize the dangers of sun exposure.
Diaper Rash Products
products are a necessity for parents whose children are not yet toilet trained.12
If skin is allowed to remain in prolonged contact with urine and feces, the pH
becomes favorable for reactivation of skin-destructive enzymes.1
The obvious method to avoid diaper rash is to change diapers as soon as they
are wet or soiled. However, for a variety of reasons, this is not always
practical. Therefore, parents often ask for advice concerning an ongoing case
of diaper rash. If the skin is already broken, the baby should be referred to
the pediatrician to assess the skin for the presence of a bacterial or
candidal infection. If the skin is merely inflamed, however, the pharmacist
can recommend a variety of diaper rash products.
Some diaper rash products are
potentially dangerous and should be avoided.1,13 They include A+D
Original Ointment (contains lanolin, a potential allergen), Balmex (inactive
ingredients include aloe vera and balsam of Peru, not known to be safe when
applied to babies), Boudreaux's Butt Paste (contains Peruvian balsam,
potentially dangerous boric acid, and castor oil [unknown safety/efficacy]),
and Hyland's Diaper Ointment (contains calendula [unknown safety/efficacy] and
The list of products with
which to exercise caution also includes Johnson's Baby Oil.1,13
This product contains mineral oil, which the FDA discussed as a possible cause
of chronic irritation and folliculitis. Johnson's Original Baby Powder and
Medicated Baby Powder contain talc and cornstarch, respectively. Using powders
around the baby is a practice that can cause inhalation pneumonia. Thus,
powdered products should be used very cautiously, if at all. The parent or
caregiver who insists on their use should be instructed to place a small
amount into the hand while away from the baby's head, then pat it gently on
the diaper area without raising a cloud of injurious dust. The safest and most
effective diaper rash ingredient may well be simple petrolatum, typified by
Vaseline Nursery Jelly. Using this product avoids the potential allergenicity
of lanolin, the possible toxicity of boric acid/borates, and the dangers of
inhalation posed by powders.
Pediatric Dosing Charts
A final issue is
that of pediatric dosing charts. Pharmacists noticed the widespread voluntary
recall of various cough and cold medications advertised and promoted for
infants while lacking any proof of safety and efficacy in that group. The
recall was issued just prior to an FDA meeting that confirmed the need to
remove these products from the market. The manufacturers have also engaged in
a practice that may cause pediatric dangers. Since the 1980s, many have
published pediatric dosing charts purporting to provide pediatric doses of
antidiarrheal medications, analgesics, and cough/cold products.1
These doses were not known to be safe and effective through legitimate
research submitted to the FDA. If these charts are still to be found in
pharmacies, they should be discarded and never consulted.
1. Pray WS. Nonprescription
Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams &
2. Alonso-Zaldivar R.
Drug companies: no cold medicines for kids under 4. October 7, 2008.
Accessed October 8, 2008.
3. Denloye O, Bankole
OO, Aderinokun GA. Teething myths among community health officers. Odontostomatol
4. Al-Nouri L, Basheer
K. Mothers' perceptions of fever in children. Trop Pediatr.
5. Sarrell E, Horev Z,
Cohen Z, Cohen H. Parents' and medical personnel's beliefs about infant
teething. Patient Educ Couns. 2005;57:122-125.
6. Gupta SK. Update on
infantile colic and management options. Curr Opin Investig Drugs.
7. Sas D, Enrione M,
Schwartz R. Pseudomonas aeruginosa septic shock secondary to "gripe
water" ingestion. Pediatr Infect Dis J. 2004;23:176-177.
8. Bond GR. Home syrup
of ipecac use does not reduce emergency department use or improve outcome. Pediatrics.
9. American Academy of
Pediatrics Committee on Injury, Violence, and Poison Prevention. Poison
treatment in the home. Pediatrics. 2003;112:1182-1185.
10. Shannon M. The
demise of ipecac. Pediatrics. 2003;112:1180-1181.
11. Sunscreen drug
products for over-the-counter human use; final monograph. Final rule. Fed
12. Skin protectant
drug products for over-the-counter human use; final monograph. Final rule. Fed
13. Skin protectant
drug products for over-the-counter human use; proposed rulemaking for diaper
rash drug products. Fed Regist. 1990;55:25204-25232.
14. Lewis TV, Badillo
R, Schaeffer S, et al. Salicylate toxicity associated with administration of
Percy medicine in an infant. Pharmacotherapy. 2006;26:403-409.
15. Percy Medicine.
www.percymedicine.com. Accessed September 23, 2008.
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