Soothing Tender Gums — Pharmaceutical Options

Teething. In some children, it starts as early as a few months of age, and it generally continues on and off through the acquisition of the second deciduous molars around age 2. While some babies and toddlers don’t appear particularly bothered by teething, others exhibit a host of symptoms including irritability, sleeplessness, fever, drooling (with rash around the mouth and in the diaper area as a result of increased secretions), and loss of appetite. While it’s difficult to gauge the level of pain a pre-verbal child is experiencing, most parents have a good sense of when their baby is uncomfortable. The question is whether to treat teething pain with anything more than a frozen washcloth to gnaw on, and some extra love and understanding. This article evaluates pharmaceutical options for teething pain.

Many pediatricians recommend acetaminophen, commonly sold under the brand name Tylenol, for infant and toddler teething discomfort. Acetaminophen is generally safe if given in the appropriate amount (Lesko et al), but is highly toxic and can lead to liver damage and death in the case of an accidental overdose (Heubi et al). While parents may dismiss concerns about acetaminophen overdose — how hard can it be to follow the directions on the package? — there are several confounding factors here. First, acetaminophen for infants and children is sold in the form of a liquid. Until quite recently, there were two suspension strengths: one for infants (80 mg/0.8 mL) and one for children (160 mg/ 5 mL). This resulted in the potential for significant confusion, as well as the potential for overdose. In response to recommendations from an FDA advisory committee meeting (Krenzelok), the infant-strength suspensions have been dropped, which should help minimize confusion. There are additional problems, however. Many cold medications contain acetaminophen in addition to other active ingredients, meaning that giving a child Tylenol for pain and a cold medication for the runny nose often exhibited during teething could lead to inadvertent acetaminophen overdose. This underlines the importance of knowing the active ingredients in all medications given. Even if parents avoid combination medications and watch dosing carefully, however, it’s possible to overdose a child through poor communication; multiple doses delivered in close temporal proximity by two well-meaning parents, or a parent and another caregiver, pose a significant risk. Additionally, while acetaminophen is reasonable and low-risk when used carefully and occasionally, it’s not appropriate for long-term pain-management. Not only does long-term use increase the risk of accidental overdose (purely as a matter of probability), it is also associated with damage to the kidneys (Perneger et al).

Because teething symptoms can go on for weeks at a time, some parents turn to alternate pain-relievers. Teething gels containing benzocaine were popular until recently; rubbed on gums, they provided temporary numbing. There has been some question as to whether numbing of the gums — which almost always leads to at least some degree of tongue-numbing — might affect a breastfeeding baby’s ability to latch properly. There does not appear to be any scientific evidence to support this notion, and while it’s hypothetically plausible, it’s unlikely that an older baby (i.e., one who would be teething) with well-developed breastfeeding habits would experience significant latch issues in response to oral numbing gels. Numb tongues aside, benzocaine-containing gels pose a risk of rare but serious adverse reactions. The FDA warns that benzocaine has the potential to react chemically with hemoglobin, which is the protein in red blood cells that carries oxygen to the tissues. The altered protein produced in the reaction, called methemoglobin, can’t carry oxygen effectively, which can result in chemical suffocation. Analysis of the incidence of adverse reactions to benzocaine and dose required to produce an adverse reaction revealed 132 cases of methemoglobinemia between November 1997 and March 2002. Only 69 of the reported events specified the dose used, but of those, 37 indicated use consistent with package directions (i.e. appropriate dosing) (Moore et al). The FDA recommends that benzocaine-containing gels and sprays not be used on children younger than 2.

Clove oil-based gels are an alternative to benzocaine gels in a few over-the-counter preparations, and appeal to some parents because they are “natural” (though natural doesn’t necessarily mean safe, as evidenced by such natural substances as botulin toxin, which causes botulism, and amanita toxin, found in the death cap mushroom). Clove oil is a common dental analgesic that affects the ability of nerves in the gums to transmit pain signals (Park et al). However, the National Institutes of Health advise against using clove oil in children, on the grounds that it can cause adverse reactions including seizures and liver damage. This recommendation is based upon a few isolated cases of clove oil toxicity (see, for instance, Lane et al, Hartnoll et al). While these cases certainly demonstrate the possible risks of clove oil use, the quantities involved in these single-case studies were massive (many mLs of pure clove oil). There is limited toxicological data available for clove oil; according to Fisher Scientific (a publisher of Material Safety Data Sheets) the LD50 for rats — the dose required to kill 50% of exposed subjects — is somewhere in the range of 1300-2600 mg/kg for oral administration, but how and whether this translates to humans isn’t known. Material Safety Data Sheets from other sources (including Oxford University) indicate that there is no known health risk associated with clove oil. This lack of safety information is actually quite typical of “natural” (i.e., non-engineered) substances, because they’re regulated somewhat differently than pharmaceuticals by the FDA per the Dietary Supplement Health and Education Act of 1994. In short, the FDA does not require manufacturers of dietary supplements to prove safety or efficacy prior to distribution. Still, clove oil has a long history of use as an oral analgesic, and is incorporated into the armamentarium of the mainstream dental practitioner. It’s unlikely that occasional, judicious application will do much harm.

Science Bottom Line:* Occasional acetaminophen, used cautiously and with good communication between caregivers, is not likely to pose a risk. Evidence supports avoiding benzocaine-containing gels. Clove oil-containing gels are likely safe, particularly if they’re produced by a major national pharmaceutical company (since larger companies are more likely to produce standardized products and, in any case, have more to lose in the event of an error, which can motivate care in product production). Smaller brand clove oil gels, however, may be problematic because of the lack of FDA oversight, and carry with them the possibility of inconsistent or inaccurate active ingredient concentration.

 

What do you use to soothe tender gums?

 

References:

FDA Drug Safety Communication (OTC Benzocaine Gels). Accessed 26 Sept 2011.

FDA Dietary Supplements. Accessed 26 Sept 2011.

Fischer Scientific Material Safety Data Sheet – Clove Oil. Accessed 26 Sept 2011.

Hartnoll et al. Near fatal ingestion of oil of cloves. Arch Dis Child. 1993 Sep;69(3):392-3.

Heubi et al. Therapeutic misadventures with acetaminophen: Hepatoxicity after multiple doses in children. J Pediatr. 1998 Jan;132(1):22-7.

Krenzelok. The FDA Acetaminophen Advisory Committee Meeting – what is the future of acetaminophen in the United States? The perspective of a committee member. Clin Toxicol (Phila). 2009 Sep;47(8):784-9.

Lane et al. Clove Oil Ingestion in an Infant. Hum Exp Toxicol. 1991 Jul;10(4):291-4.

Lesko et al. The Safety of Acetaminophen and Ibuprofen Among Children Younger Than Two Years Old. Pediatrics. 1999 Oct;104(4):e39.

Moore et al. Reported Adverse Event Cases of Methemoglobinemia Associated With Benzocaine Products Arch Intern Med. 2004 Jun 14;164(11):1192-6.

National Institutes of Health — Medline Clove. Accessed 26 Sept 2011.

Oxford University Physical and Theoretical Chemistry Laboratory Material Safety Data Sheet – Clove Oil. Accessed 26 Sept 2011.

Park et al. Eugenol Inhibits Sodium Currents in Dental Afferent Neurons. J Dent Res. 2006 Oct;85(10):900-4.

Perneger et al. Risk of Kidney Failure Associated with the Use of Acetaminophen, Aspirin, and Nonsteroidal Antiinflammatory Drugs. N Engl J Med. 1994 Dec 22;331(25):1675-9.

*The “Science Bottom Line” at the end of each article is not intended as medical advice. It is merely my analysis of one or more papers referenced in a given post.

**”SquintMom’s Decision,” likewise, is not intended as medical advice. It’s merely what I do in my own home, based upon the results of my analysis of the information available.

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6 Comments (+add yours?)

  1. Katy
    Sep 27, 2011 @ 16:44:19

    When my first child was teething his doctor suggested that we avoid teething gels because they can make swallowing difficult. I used to use Hyland Teething Tablets and they helped but were recalled by Hyland when the FDA raised concerns. Now, I massage my teether's gums with a clean finger and provide him with something to chew on.

    Reply

    • SquintMom
      Sep 27, 2011 @ 22:16:15

      Katy, you read my mind! I am going to follow this article up with one on non-pharmaceutical (alternative) teething remedies 🙂

      Reply

  2. ScienceofMom
    Sep 29, 2011 @ 14:33:29

    Hi Kirsten – Great article! How about ibuprofen though? As far as I know, it is safe to use in infants older than 6 months (but I haven't looked closely), and we like it because a dose lasts longer than acetominophen, making it better for overnight use. Did you come across any safety info on ibuprofen?

    Reply

    • SquintMom
      Sep 29, 2011 @ 16:48:27

      Thanks for your comments. While ibuprofen isn't as commonly recommended for teething (for no particular discernible reason), it has a safety and efficacy profile similar to acetaminophen (see, for instance, Ashraf et al. Safety profile of ibuprofen suspension in young children. Inflammopharmacology. 1999;7(3):219-25.) Some parents may find that it works better and lasts longer than acetaminophen, others have better luck with acetaminophen. If your baby is really uncomfortable, it's actually safe and effective to alternate the two drugs (see, for instance, Sarrell et al. Antipyretic Treatment in Young Children With Fever. Arch Pediatr Adolesc Med. 2006 Feb;160(2):197-202.)

      Reply

  3. J
    Jan 28, 2012 @ 02:44:33

    I recently (in the last 1-2 months) read something in the popular press resorting on a study that showed a link between acetaminophen use in young children and asthma, particularly linking the rise in asthma cases to the rise in acetaminophen use (driven by the switch away from aspirin due to Reyes syndrome and the indiscriminate use of acetominophen by many parents to pre-emotively treat perceived teething pain). Your take on that angle might be a helpful add to this post.

    Reply

    • SquintMom
      Jan 28, 2012 @ 18:07:45

      I’ll check into it! Thanks for the tip! Regardless of what the article says, though (and regardless of whether there’s a link between acetaminophen and asthma), it’s NEVER a good idea to overuse any medication, acetaminophen included!!

      Reply

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