Over-the-counter medications for crying or teething

Can I buy something to settle my crying baby?

Various over-the-counter products claim to reduce crying due to gas, colic, teething, or hiccups, but there is no evidence they are effective. They may in fact be dangerous. Gripe water contains baking soda, which temporarily reduces acid levels but also creates gas. Baking soda may also increase the risk of high calcium levels in the blood and the risk of kidney disease. Over-the-counter products may contain sugars, thickeners, flavouring, oils, anti-foaming agents, preservatives, and herbal extracts. There have been reports of contamination with dangerous drugs, bacteria, and metal fragments. Preparations marketed for teething that numb or freeze a baby’s gums can cause serious adverse reactions.

A) Product claims

Various over-the-counter products claim to reduce a baby’s crying by treating:

These products have not been shown to be effective at reducing crying (Biagioli 2016; Cohen-Silver 2009; Hall 2012; Lucassen 1998; Metcalf 1994). Some may have side-effects or be contaminated with unintended ingredients or bacteria. They may also delay diagnosis and effective treatment of illnesses.

B) Gripe water-type products

Gripe water has not been shown to be effective and may have side effects (Jain 2015).

Gripe water-type products remain popular with caregivers. The original gripe water was produced in the 1850s by William Woodward, an English pharmacist, and was based on an ineffective cure for malaria. It contained 3.6% alcohol (slightly less than regular beer) and similar products have contained as much as 9% (Blumenthal 2000).

Alcohol is not recommended for babies because of concerns about its effect on brain development and has been removed from most current preparations. 

Gripe water preparations may contain herbs (dill seed oil, fennel, ginger, chamomile, cardamom, licorice, cinnamon, clove, lemon balm, or peppermint) and generally have large amounts of sugar (Adhisivam 2012). They usually have sodium bicarbonate (baking soda), which mixes with acid in the stomach and very temporarily reduces acid levels. However, this chemical reaction also creates gas (carbon dioxide). This extra gas in the baby’s stomach is unlikely to reduce any pain.

Bicarbonate may also increase the risk of high calcium levels in the blood and kidney disease (milk alkali syndrome).

C) Ingredients of over-the-counter products

Over-the-counter products advertised to calm babies may contain:

  • Sugars (Strickley 2008)
  • Sweeteners (such as sorbitol, sucrose)
  • Simethicone (or simeticone), a silicone-based anti-foaming agent
  • Flavourings (such as xylitol)
  • Herbal extracts
  • Oils
  • Thickeners, emulsifiers, stabilizers, and smoothing agents (such as glycerin, polysorbate, and propylene glycol)
  • Preservatives and antimicrobial and antifungal agents (such as sodium benzoate, methylparaben,  propylparaben, ethylenediaminetetraacetic acid [EDTA])

Sugar is often added to make them taste better, but it can increase the risk of tooth decay (Zhao 2017).

Just like the older treatments for colic, some over-the-counter products can be dangerous. There have been reports of contamination with:

  • The drug belladonna (FDA 2016b)
  • Microbes (AAP 2007; Health Canada 2019; Sas 2004)
  • Metal fragments (Reuters Staff 2008)

D) Herbal preparations

There is very little research showing that herbal preparations can reduce infant crying and there are major concerns that they pose a risk (Sung 2018). A few studies have reported limited benefits (Anheyer 2017):

  • Potentilla erecta, carob bean juice, and Matricaria chamomilla (diarrhea)
  • Peppermint oil (abdominal pain in children)
  • Fennel preparations (colic)

Herbal preparations may contain harmful chemicals, toxic contaminants, or bacteria that can affect the baby (Al-Nabulsi 2009; Corns 2003; Mädge 2015; Minodier 2003; Tomassoni 2001; Zachara 2018).

Herbal teas may reduce the amount of milk a baby takes in and result in poor growth.

Herbs used to increase milk supply can also pose risks.

E) Over-the-counter teething products

Teething gels and tablets are not recommended for pain that may be caused by teething (FDA 2016a).

Teething gels that numb or freeze a baby’s gums generally contain members of the “caine” family (such as lidocaine or benzocaine). These can cause:

  • Jitteriness
  • Confusion
  • Vision problems
  • Vomiting
  • Falling asleep too easily
  • Shaking
  • Seizures

The “caine” family, especially benzocaine, can also cause a condition in which the blood has very little oxygen (methemoglobinemia) and appears blue. The U.S. Food and Drug Administration evaluated 119 cases of this condition between 2009 and 2017 (FDA 2018a). Most of these people required treatment and four died.

The FDA says over-the-counter oral drug products containing benzocaine should not be used to treat children, as these products carry serious risks and provide little or no benefit for treating oral pain (FDA 2018b).

References

Adhisivam B. Is gripe water baby-friendly?  Journal of Pharmacology & Pharmacotherapeutics. 2012;3(2):207-208
 
Al-Nabulsi AA, Osaili TM, Shaker RR, et al. Survival of Cronobacter species in reconstituted herbal infant teas and their sensitivity to bovine lactoferrin. J Food Sci. 2009 Nov-Dec;74(9):M479-84
 
American Academy of Pediatrics (AAP). FDA traces infant's Cryptosporidium infection to Baby's Bliss Gripe Water herbal supplement. AAP News Sep 2007, 28 (9) 2007281
 
Anheyer D, Frawley J, Koch AK, et al. Herbal Medicines for Gastrointestinal Disorders in Children and Adolescents: A Systematic Review. Pediatrics. 2017 Jun;139(6). pii: e20170062
 
Biagioli E, Tarasco V, Lingua C, et al. Pain-relieving agents for infantile colic. Cochrane Database of Systematic Reviews 2016, Issue 9. Art. No.: CD009999
 
Blumenthal I. The gripe water story. J R Soc Med. 2000 Apr;93(4):172-4
 
Cohen-Silver J, Ratnapalan S. Management of infantile colic: a review. Clin Pediatr (Phila). 2009 Jan;48(1):14-7
 
Corns CM. Herbal remedies and clinical biochemistry. Ann Clin Biochem. 2003 Sep;40(Pt 5):489-507
 
Hall B, Chesters J, Robinson A. Infantile colic: a systematic review of medical and conventional therapies. J Paediatr Child Health. 2012 Feb;48(2):128-37
 
Health Canada; Recalls and safety alerts. RW Consumer Products Ltd. voluntarily recalls all lots of "Gripe Water – Alcohol And Preservative Free" because of microbial contamination. Ottawa: Health Canada; 2019 Sept 21 [cited 2019 Sep 22]
 
Jain K, Gunasekaran D, Venkatesh C, et al. Gripe Water Administration in Infants 1-6 months of Age-A Cross-sectional Study. J Clin Diagn Res. 2015 Nov;9(11):SC06-8
 
Lucassen PL, Assendelft WJ, Gubbels JW, et al. Effectiveness of treatments for infantile colic: systematic review. BMJ. 1998 May 23;316(7144):1563-9
 
Mädge I, Cramer L, Rahaus I. Pyrrolizidine alkaloids in herbal teas for infants, pregnant or lactating women. Food Chem. 2015 Nov 15;187:491-8
 
Metcalf TJ, Irons TG, Sher LD, et al. Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial. Pediatrics. 1994 Jul;94(1):29-34
 
Minodier P, Pommier P, Moulène E, et al. [Star anise poisoning in infants]. Arch Pediatr. 2003 Jul;10(7):619-21
 
Reuters Staff. J&J, Merck recall Mylicon infant anti-gas drops. [Internet]. [Place unknown]: Reuters; 2008 Nov 10 [cited 2017 Oct 10]
 
Sas D, Enrione MA, Schwartz RH. Pseudomonas aeruginosa septic shock secondary to "gripe water" ingestion. Pediatr Infect Dis J. 2004 Feb;23(2):176-7
 
Strickley RG, Iwata Q, Wu S, et al. Pediatric drugs--a review of commercially available oral formulations. J Pharm Sci. 2008 May;97(5):1731-74
 
Sung V. Infantile colic.  Australian Prescriber. 2018;41(4):105-110
 
Tomassoni AJ, Simone K. Herbal medicines for children: an illusion of safety? Curr Opin Pediatr. 2001 Apr;13(2):162-9
 
U.S. Food and Drug Administration (FDA 2016b). FDA News Release: FDA warns against the use of homeopathic teething tablets and gels. Maryland: U. S. Food and Drug Administration; 2016 Sep 30 [cited 2019 Apr 1]
 
U.S. Food and Drug Administration (FDA 2016a). Raritan Pharmaceuticals Inc. Issues a Voluntary Nationwide Recall of Products Containing Belladonna Extract Due to the Possibility of the Presence of Belladonna Alkaloids. Maryland: U. S. Food and Drug Administration; 2016 Nov 25 [cited 2019 July 12]
 
U.S. Food and Drug Administration (FDA 2018b). Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. Maryland: U. S. Food and Drug Administration; 2018 May 23 [cited 2019 Mar 30]
 
U.S. Food and Drug Administration (FDA 2018a). Safely Soothing Teething Pain and Sensory Needs in Babies and Older Children. Maryland: U. S. Food and Drug Administration; 2018 Dec 20 [cited 2019 Apr 2]
 
Zachara A, Gałkowska D, Juszczak L. Contamination of Tea and Tea Infusion with Polycyclic Aromatic Hydrocarbons. International Journal of Environmental Research and Public Health. 2018;15(1):45
 
Zhao D, Tsoi JK, Wong HM, et al. Paediatric Over-the-Counter (OTC) Oral Liquids Can Soften and Erode Enamel. Dent J (Basel). 2017 May 11;5(2)