Swanson – Over-the-Counter Drugs

A 6-month-old infant is brought to your office because of a runny nose, cough, and mild fever for the past 4 days. The infant was playful but occasionally fussy, and his temperature reached 39° C. He is otherwise healthy, and his immunizations are up to date.

On physical examination, the child looks well and is afebrile. He has nasal congestion and a hyperemic pharynx. Tympanic membranes look normal. His lungs are clear and heart sounds are regular.

1. The infant’s mother is concerned about the Your recommendation to her would be: treat the fever with elixir of acetaminophen if it reaches 39° C again
   The basic axiom relevant to this question is that “not all fever has to be treated with drugs.” Fever with temperatures below 39° C in healthy children generally does not require treatment. Temperatures above this may cause significant discomfort and may need the administration of an antipyretic. Increased body temperature is associated with decreased microbial reproduction and increased inflammatory reaction. Therefore, most evidence suggests that moderate fever is beneficial and should be treated only in selected circumstances. Febrile convulsions, which may occur in approximately 4% of children, may be of concern in a susceptible child with rapidly rising fever. Acetaminophen is the best choice. There is no evidence that alternating acetaminophen with ibuprofen is of any benefit, and it may not be safe. Symptomatic treatment, such as tepid sponge bathing, is helpful when it is used with antipyretic therapy.
   
2. What is the analgesic agent of choice in the treatment of childhood fever and mild childhood pain? elixir of acetaminophen
   The analgesic agent of choice in the treatment of childhood fever and mild to moderate childhood pain is acetaminophen. Hydromorphone is a strong narcotic. Naproxen is a nonsteroidal antiinflammatory agent, and aspirin is contraindicated (see answer 3). Acetaminophen with codeine elixir is available and may be indicated in more severe pain syndromes in childhood.
   
3. Which is the most accurately reflects current practice recommendations regarding antipyretics and analgesics for fever and mild pain in children? acetaminophen is the most widely used antipyretic and mild analgesic for children
   Acetaminophen is the most widely accepted analgesic of choice for the treatment of fever and childhood pain. Pediatric use of aspirin has decreased since the 1970s after a report of its association with Reye syndrome. Aspirin use for fever reduction and mild pain associated with URIs is not recommended in children. Not all childhood pain needs to be treated with drugs. Many children will do just as well and feel just as well without drug use.
4. Regarding the use of antihistamines in children, which of the following statements is true? young children may develop seizures when given antihistamine doses (tablets or suppositories) that are meant for older children (on a milligram per kilogram basis)
   Antihistamines remain a popular therapy for cold-associated symptoms such as rhinorrhea and congestion. The mechanisms causing these in a viral URI differ from the allergy-related rhinorrhea secondary to histamine release. Antihistamines do not alleviate these symptoms to a clinically significant degree, especially in the pediatric population. They do not shorten the course of the viral illness, nor do they prevent its complications. They may produce tachycardia, blurred vision, agitation, hyperactivity, and seizures when given in toxic doses. The younger the child, the easier it is to inadvertently produce antihistamine toxicity. Treatment of a viral URI in an infant or young child should consist of reassurance and cool steam or saline nasal drops (if nasal congestion is present) and bulb syringe suctioning of nasal passages.
5. Regarding the relief of nasal congestion in infants and children, which of the following statements is true? nasal bulb suctioning done too frequently can cause nasal trauma, swelling of nasal mucosa, and greater congestion
   Supportive therapy with humidified air, nasal saline drops, and bulb suctioning is effective in producing relief of nasal congestion in infants and young children. These therapies are safer and less expensive than medications. Saline nasal drops may be used before suctioning. Suctioning is most likely to be helpful before feeds and sleep. However, done too frequently, suctioning may lead to nasal trauma, mucosal swelling, and greater congestion. If using a humidifier in the child’s room, it is safer to use a humidifier that emits cool steam to avoid the risk of burns. Warm steam (such as from turning on the shower in the bathroom) also produces significant symptomatic relief of nasal congestion. Steam appears to be the key in symptom resolution without any added ingredients in the water.

The child returns 3 days later with his mother. She states that despite your treatment, the child has not improved. He now has significantly greater nasal congestion and is having difficulty breathing at night. She has been using an over-the-counter (OTC) cold medication and asks if she should use something stronger. Physical examination is completely normal. You do not notice any change in the state of the nasal congestion.

• With respect to treatment of this infant at this time, what would you tell the mother? decongestants have not been shown to reduce the duration of viral URI symptoms; use nasal saline with bulb suctioning of nasal passages and humidified air instead of a decongestant; reassure the mother and educate her about common cold and antihistamine-decongestant use; overstimulation is a common side effect when decongestant preparations are given Education of parents about the lack of benefit and known risks of OTC cough and cold preparations is the best tool for reducing misuse or overdose with these medications. Sympathomimetics do not decrease the duration of illness, have not been shown to be of benefit in young children, and may cause significant side effects and toxicity even with use of topical agents. If parents insist on using these medications, it should be negotiated to discontinue them in 2 days if no benefit is observed.

The parent of an 18-month-old girl calls your office with a complaint that the toddler has had a persistent cough for the past 10 days. You saw the child for a routine checkup a few months ago. The cough is nonproductive, and the mother believes it is significantly interfering with the child’s sleep. The child is otherwise well. She makes an appointment to see you in a couple of days and asks if you could recommend an OTC cough medication for her child.

• Regarding the use of antitussives or expectorants in infants and children, which of the following statements is true? there is a lack of evidence that any OTC medicine is effective in treating pediatric cough

Centrally acting cough suppressants such as dextromethorphan and codeine are not recommended for treatment of cough associated with viral illnesses. Dextromethorphan is the most common ingredient in OTC cough medicines. It has been reported to produce drowsiness, respiratory depression, abnormal limb movements, and coma in infants and children. Similar to antihistamines and decongestants, dextromethorphan has not been shown to shorten the duration of respiratory tract illness in children or adults nor to be superior to placebo in controlling the cough. Many cough preparations also contain an expectorant. The combination of a cough suppressant and an expectorant is not recommended.

Time remains the best cure for the viral URI symptoms. The use of a nasal aspirator (bulb syringe) with or without saline nasal drops will help clear a young infant’s nasal secretions and make feeding easier. In infants who are irritable and feverish from viral symptoms, acetaminophen is the safest OTC drug to use.

A mother brings her 13-month-old infant to the office for assessment of vomiting and diarrhea. The child has had these symptoms for approximately 2 days. The child is otherwise active and healthy.

• What do you tell the mother regarding use of antiemetics and antimotility agents available OTC? use of antimotility agents such as loperamide is associated with complications such as ileus and respiratory depression; viral gastroenteritis is self-limited and does not need any treatment other than prevention of dehydration

Antimotility agents and antiemetics should not be used for the treatment of vomiting and diarrhea secondary to gastroenteritis in children (especially very young children). These agents have not been shown to be beneficial in the treatment of viral gastroenteritis and are associated with adverse effects. Maintenance of hydration is the mainstay in the treatment of viral gastroenteritis. In cases in which oral hydration cannot be maintained because of severe vomiting and in cases of severe dehydration, intravenous hydration may be considered.

A mother brings her 8-month-old infant to your office for assessment of fever, diarrhea, and red cheeks that she attributes to teething. She was advised by her neighbor to purchase a preparation of topical benzocaine. This has not helped.

• Which of the following statements regarding this infant is true? acetaminophen is a reasonable treatment for a child who is teething; teething often begins at 4 to 6 months of age and continues intermittently up to the age of 2 years

Teething usually begins at 6 to 8 months of age and continues until the age of 2 years. Although often blamed on teething, there is no good evidence that fever, mood disturbances, appearance of illness, sleep disturbance, drooling, diarrhea, strong urine, red cheeks, rashes, or flushing of the face or body is associated with teething. Although topical benzocaine usually does not produce any side effects, cases of methemoglobinemia have been reported in children who have been treated with this agent. Teething is best treated with reassurance and appropriate doses of acetaminophen.

• In addition to the side effects of the various ingredients in OTC cough and cold preparations, which of the following is (are) also a potential hazard(s) when these medications are given?
  1. risk of potential serious overdose, especially in children younger than 2 years
  2. if symptoms are not controlled, parents sometimes intentionally, without intending to harm, give higher than recommended doses
  3. parents are often unaware of the possible side effects
  4. parents sometimes give the medications for one of the side effects—sedation

All are potential hazards when OTC cold and cough medications are given to infants and children. It is important for physicians to inquire about and to educate parents on the use of all OTC medications. The “active ingredient” is what makes the medicine work and is always listed at the top of the Drug Facts label. An active ingredient can sometimes treat more than one medical condition and may be found in many different medicines that are used to treat different symptoms. For example, a medicine for a cold and a medicine for a headache could each contain the same active ingredient. Therefore, if parents are treating a cold and pain with two medicines and both have the same active ingredient, they could be giving two times the normal dose.