OTC Products and Certain Patient Groups
Several patient groups are particularly susceptible to adverse events caused by OTC products. These populations include children, the elderly, pregnant and breastfeeding women, and patients with preexisting conditions.
Children
Pain Relievers/Fever Reducers
Parents often have questions about treating pain, fever and other symptoms associated with the flu and the common cold. A recent meta-analysis found that single doses of acetaminophen and ibuprofen are safe and effective for treating moderate to severe pain and fever in children younger than 18 years of age.68 Because the safety of naproxen and ketoprofen in children is less well known, naproxen is not recommended for children under age 12 and ketoprofen is not recommended for children under age 16. The use of aspirin should be avoided in children under the age of 18 because of the risk of Reye’s syndrome.
Cough and Cold Medications
In October 2007, the FDA’s Nonprescription Drugs and Pediatric Advisory Committee met to discuss the questions surrounding the safety and efficacy of OTC cough and cold products in children under age 12. The committee found there was no proof that these medicines eased cold symptoms in children, while there have been rare reports that they have caused serious harm. The panel therefore voted 21-1 to recommend against use of these products in children under 2 years of age and voted 13-9 to recommend against their use in children ages 2 to 6 years.69 In January 2008, the FDA released a public health advisory recommending against the use of OTC cough and cold medications in children under age 2.4 A public meeting to discuss further recommendations is anticipated in October 2008; at this meeting, the FDA is expected to recommend against the use of these medications in children under age 4. Many manufacturers have voluntarily removed from the market products labeled for use in infants and babies, an action that the FDA’s advisory applauds.4
In light of these warnings, parents will almost certainly turn to physicians and pharmacists for advice on how to treat their children’s cold and flu symptoms. As a practical matter, it is prudent to remind parents that most of the ingredients found in OTC cough and cold medicines have not been shown to be effective in children,18,33,34 and that some children have experienced serious adverse effects after taking them.23 It may also be helpful to remind parents about the typical timeline of the common cold and advise them to make sure their children get plenty of rest and fluids. Physicians can also suggest nonpharmacologic options for symptom relief such as saline nose drops and humidifiers. Parents of infants may want to try having the child sleep in an upright position (as in a carrier) and using a nasal bulb syringe to clear the nasal passageways.
Parents often have questions about treating pain, fever and other symptoms associated with the flu and the common cold. A recent meta-analysis found that single doses of acetaminophen and ibuprofen are safe and effective for treating moderate to severe pain and fever in children younger than 18 years of age.68 Because the safety of naproxen and ketoprofen in children is less well known, naproxen is not recommended for children under age 12 and ketoprofen is not recommended for children under age 16. The use of aspirin should be avoided in children under the age of 18 because of the risk of Reye’s syndrome.
Cough and Cold Medications
In October 2007, the FDA’s Nonprescription Drugs and Pediatric Advisory Committee met to discuss the questions surrounding the safety and efficacy of OTC cough and cold products in children under age 12. The committee found there was no proof that these medicines eased cold symptoms in children, while there have been rare reports that they have caused serious harm. The panel therefore voted 21-1 to recommend against use of these products in children under 2 years of age and voted 13-9 to recommend against their use in children ages 2 to 6 years.69 In January 2008, the FDA released a public health advisory recommending against the use of OTC cough and cold medications in children under age 2.4 A public meeting to discuss further recommendations is anticipated in October 2008; at this meeting, the FDA is expected to recommend against the use of these medications in children under age 4. Many manufacturers have voluntarily removed from the market products labeled for use in infants and babies, an action that the FDA’s advisory applauds.4
In light of these warnings, parents will almost certainly turn to physicians and pharmacists for advice on how to treat their children’s cold and flu symptoms. As a practical matter, it is prudent to remind parents that most of the ingredients found in OTC cough and cold medicines have not been shown to be effective in children,18,33,34 and that some children have experienced serious adverse effects after taking them.23 It may also be helpful to remind parents about the typical timeline of the common cold and advise them to make sure their children get plenty of rest and fluids. Physicians can also suggest nonpharmacologic options for symptom relief such as saline nose drops and humidifiers. Parents of infants may want to try having the child sleep in an upright position (as in a carrier) and using a nasal bulb syringe to clear the nasal passageways.
Elderly Patients
About 20 percent to 30 percent of elderly patients take an analgesic medication on a given day.70 When taken as directed and for a short period of time, OTC medications are generally well tolerated.70 However, elderly patients often take multiple prescription medications as well. For this reason, the most important concern related to OTC use in this group is the risk of interactions with prescription medications. The other critical issue is the effect an OTC agent may have on patients’ chronic health conditions.
Pain Relievers
As physicians and pharmacists are well aware, NSAIDs should be used with caution in this population given the higher incidence of cardiovascular and GI disease, age-related decline in renal function and the likelihood of polypharmacy.71 Likewise, the use of aspirin, even low-dose aspirin, can affect renal function in the elderly.72 Therefore, acetaminophen is generally considered the drug of choice for elderly patients looking for an OTC pain reliever to treat their mild to moderate pain.73
Cough and Cold Medications
Sympathomimetic decongestants such as pseudoephedrine and phenylephrine can be problematic in elderly patients because they can elevate blood and intraocular pressure, and may worsen existing urinary obstruction. In addition, adverse interactions are possible with a number of medications, including beta blockers, methyldopa, tricyclic antidepressants, oral hypoglycemic agents and MAOIs.52
Care should also be taken when recommending first-generation antihistamines to elderly patients. Sedative and anticholinergic effects may be enhanced because of diminished capacity for drug metabolism. Limited data regarding the use of OTC antitussives in elderly patients are available, but dextromethorphan should not be used by patients taking an MAOI.52 There is little published research into the effects of guaifenesin in the elderly.
Pain Relievers
As physicians and pharmacists are well aware, NSAIDs should be used with caution in this population given the higher incidence of cardiovascular and GI disease, age-related decline in renal function and the likelihood of polypharmacy.71 Likewise, the use of aspirin, even low-dose aspirin, can affect renal function in the elderly.72 Therefore, acetaminophen is generally considered the drug of choice for elderly patients looking for an OTC pain reliever to treat their mild to moderate pain.73
Cough and Cold Medications
Sympathomimetic decongestants such as pseudoephedrine and phenylephrine can be problematic in elderly patients because they can elevate blood and intraocular pressure, and may worsen existing urinary obstruction. In addition, adverse interactions are possible with a number of medications, including beta blockers, methyldopa, tricyclic antidepressants, oral hypoglycemic agents and MAOIs.52
Care should also be taken when recommending first-generation antihistamines to elderly patients. Sedative and anticholinergic effects may be enhanced because of diminished capacity for drug metabolism. Limited data regarding the use of OTC antitussives in elderly patients are available, but dextromethorphan should not be used by patients taking an MAOI.52 There is little published research into the effects of guaifenesin in the elderly.
Pregnancy
Data regarding the safe use of all medications, including OTC drugs, during pregnancy are limited. Most data rely on retrospective and anecdotal studies and, as a result of ethical concerns, rigorous, controlled testing is not permissible. Nevertheless, the vast majority—more than 92 percent in one study74—of women self-treat with OTC medications during pregnancy. Combination products are best avoided during pregnancy, to minimize potential risks from the use of unnecessary medications.
In May 2008, the FDA proposed revisions to the physician labeling of prescription drugs that would eliminate the current pregnancy categories A, B, C, D and X. The physician labeling is often adapted for use in consumer-directed labeling. The FDA has invited comment on the proposed changes and will consider these comments in preparing a final rule.75
Pain Relievers
Acetaminophen is generally accepted as the pain reliever of choice during pregnancy. It is considered safe and effective (pregnancy category B) in all three trimesters.76 Aspirin should generally be avoided during pregnancy.76 The nonsalicylate NSAIDs are category B in the first and second trimesters, but category D in the third. For this reason, nonsalicylate NSAIDs should be avoided in the third trimester.76 As with any medication in pregnancy, analgesics should be used in smallest effective dose for pain relief.
Cough and Cold Medications
Pseudoephedrine is the decongestant of choice during pregnancy (pregnancy category C).76 Some studies have reported an increased risk of infant gastroschisis in pregnant patients who take pseudoephedrine during the first trimester.77 However, whether this increased risk of gastroschisis is an adverse effect of pseudoephedrine itself, its interaction with other medications or an underlying maternal illness is unclear.77 As for antihistamines, chlorpheniramine is preferable to diphenhydramine—though both are pregnancy category B—because the latter may exhibit oxytocin-like effects at high dosages.76 Dextromethorphan appears to be safe during pregnancy (pregnancy category C),76 but given its questionable efficacy for cough related to the common cold,29 it should be used sparingly, if at all. Although it is listed as pregnancy category C, use of guaifenesin has been associated with neural tube defects and should be avoided.76
In May 2008, the FDA proposed revisions to the physician labeling of prescription drugs that would eliminate the current pregnancy categories A, B, C, D and X. The physician labeling is often adapted for use in consumer-directed labeling. The FDA has invited comment on the proposed changes and will consider these comments in preparing a final rule.75
Pain Relievers
Acetaminophen is generally accepted as the pain reliever of choice during pregnancy. It is considered safe and effective (pregnancy category B) in all three trimesters.76 Aspirin should generally be avoided during pregnancy.76 The nonsalicylate NSAIDs are category B in the first and second trimesters, but category D in the third. For this reason, nonsalicylate NSAIDs should be avoided in the third trimester.76 As with any medication in pregnancy, analgesics should be used in smallest effective dose for pain relief.
Cough and Cold Medications
Pseudoephedrine is the decongestant of choice during pregnancy (pregnancy category C).76 Some studies have reported an increased risk of infant gastroschisis in pregnant patients who take pseudoephedrine during the first trimester.77 However, whether this increased risk of gastroschisis is an adverse effect of pseudoephedrine itself, its interaction with other medications or an underlying maternal illness is unclear.77 As for antihistamines, chlorpheniramine is preferable to diphenhydramine—though both are pregnancy category B—because the latter may exhibit oxytocin-like effects at high dosages.76 Dextromethorphan appears to be safe during pregnancy (pregnancy category C),76 but given its questionable efficacy for cough related to the common cold,29 it should be used sparingly, if at all. Although it is listed as pregnancy category C, use of guaifenesin has been associated with neural tube defects and should be avoided.76
Breastfeeding
The American Academy of Pediatrics (AAP) has developed a set of guidelines for the use of many prescription and nonprescription medications by women who are breastfeeding. These guidelines are available online.
Pain Relievers
In general, acetaminophen and the nonsalicylate NSAIDs are considered safe for use while a woman is breastfeeding. Salicylates can be excreted in human milk, and the use of high dosages of aspirin by a breastfeeding mother can produce effects in the nursing infant, such as rashes or abnormalities of bleeding or platelet function. For this reason, the FDA advises against the use of aspirin and other salicylates by nursing mothers.78
Cough and Cold Medications
First-generation antihistamines are excreted in breast milk, and they may cause side effects such as sedation, paradoxical stimulation, irritability, crying, sleep disturbances and refusal to feed in nursing infants. Additionally, these drugs may interfere with milk production. Long-term use should be limited.79
In August 2007, the FDA released a public health advisory regarding the use of codeine in nursing mothers. New information has shown a very rare adverse effect in breastfeeding women who take codeine. Women who are ultra-rapid metabolizers of codeine may have higher-than normal levels of morphine in their blood and breast milk, which may lead to life-threatening or fatal side effects in nursing infants. The FDA advises prescribers to prescribe the lowest therapeutic doses of codeine in breastfeeding mothers and to tell patients how to recognize high morphine levels in themselves and in their babies.80 Although many OTC preparations contain alcohol, the American Academy of Pediatrics suggests that the amount found in most medications does not pose a safety hazard for a nursing infant.79
Pain Relievers
In general, acetaminophen and the nonsalicylate NSAIDs are considered safe for use while a woman is breastfeeding. Salicylates can be excreted in human milk, and the use of high dosages of aspirin by a breastfeeding mother can produce effects in the nursing infant, such as rashes or abnormalities of bleeding or platelet function. For this reason, the FDA advises against the use of aspirin and other salicylates by nursing mothers.78
Cough and Cold Medications
First-generation antihistamines are excreted in breast milk, and they may cause side effects such as sedation, paradoxical stimulation, irritability, crying, sleep disturbances and refusal to feed in nursing infants. Additionally, these drugs may interfere with milk production. Long-term use should be limited.79
In August 2007, the FDA released a public health advisory regarding the use of codeine in nursing mothers. New information has shown a very rare adverse effect in breastfeeding women who take codeine. Women who are ultra-rapid metabolizers of codeine may have higher-than normal levels of morphine in their blood and breast milk, which may lead to life-threatening or fatal side effects in nursing infants. The FDA advises prescribers to prescribe the lowest therapeutic doses of codeine in breastfeeding mothers and to tell patients how to recognize high morphine levels in themselves and in their babies.80 Although many OTC preparations contain alcohol, the American Academy of Pediatrics suggests that the amount found in most medications does not pose a safety hazard for a nursing infant.79
Other Patient Groups
A number of special patient populations may be at increased risk of adverse events associated with OTC analgesic use.10 These groups are listed in Table 2.
| Disease or Condition | Preferred Agent(s) | Agent(s) to Use with Caution |
| Asthma or nasal polyps | Acetaminophen or nonaspirin salicylates (choline salicylate or sodium salicylate) | Aspirin, ibuprofen, ketoprofen, naproxen |
| Bleeding disorders | Acetaminophen or nonaspirin salicylates | Aspirin, ibuprofen, ketoprofen, naproxen |
| Congestive heart failure | Acetaminophen | Sodium salicylate, effervescent aspirin tablets with a high sodium content, and nonsalicylate NSAIDs |
| Dysmenorrhea | Ibuprofen, ketoprofen, naproxen | None |
| Gout | Acetaminophen or nonsalicylate NSAIDs | Salicylates |
| Hepatic impairment | Acetaminophen† | All NSAIDs |
| Hypertension | Acetaminophen | All NSAIDs |
| Lactation | Acetaminophen | Salicylates |
| Lithium therapy | Acetaminophen or aspirin | Ibuprofen, ketoprofen, naproxen |
| Methotrexate therapy | Acetaminophen | All NSAIDs |
| Type 2 diabetes managed with first-generation sulfonylureas | Acetaminophen or ibuprofen‡ | Ketoprofen, naproxen, salicylates |
| Oral anticoagulant therapy | Acetaminophen or nonaspirin salicylates§ | Aspirin, ibuprofen, ketoprofen, naproxen |
| Peptic ulcer disease | Acetaminophen | All NSAIDs |
| Pregnancy | Acetaminophen | All NSAIDs |
| Renal impairment | Acetaminophen | All NSAIDs |
| Urticaria | Acetaminophen | Salicylates |
| Varicella or influenza symptoms in a pediatric patient | Acetaminophen or ibuprofen | Salicylates |
*—This table is intended to serve as a guide for the reader; consult professional labeling before making any drug therapy recommendations. |
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Learning Objectives & Author Information