US Pharm. 2012;37(7):12-15.
Pharmacists render dozens of judgments each week in
community pharmacies when patients request assistance with treatment of
minor health problems with nonprescription products. Virtually all
nonprescription products have contraindications, and a variety of these
refer to patients with respiratory problems such as asthma, wheezing,
emphysema, or chronic bronchitis.1 When the pharmacist is
aware that a particular patient has been diagnosed with a respiratory
problem, it can be vital to advise against use of contraindicated
products, unless a physician has suggested that the patient use them.
Products Contraindicated With Asthma
Asthma was once a labeled contraindication for all
nonprescription products containing first-generation antihistamines. The
rationale behind this labeled contraindication was discussed by an OTC
review panel appointed to examine antihistamines in its original 1976
report: “The Panel is aware that a controversy exists concerning the use
of antihistamines in patients with bronchial asthma where a ‘drying
action’ is undesirable. Many physicians consider this effect to be
disadvantageous in patients with bronchial asthma and some maintain that
the antihistaminic drugs are contraindicated in patients with this
disease.”2 Products carried this label for years. In 1985,
the FDA published a tentative final monograph for antihistamines,
agreeing with the need for this label.3
In 1992, however, the FDA published its final rule on labeling for nonprescription first-generation antihistamines.4
In this document, the agency described the conclusions of a 1990
meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee.
Participants believed that first-generation antihistamines did not have
sufficient anticholinergic effects to be problematic for those with
asthma, removing the term “asthma” from the warnings. Second-generation
antihistamines (e.g., Claritin, Zyrtec, Allegra Allergy) have never been
required to carry an asthma warning.
Nonprescription cromolyn (e.g., NasalCrom) carries a warning not to use it to treat asthma.5
The product is only indicated for allergic rhinitis, and it would be
ineffective in asthma. Attempting to use it instead of rescue
bronchodilators could be fatal in an acute asthma attack. Pharmacists
should carefully question patients with a diagnosis of asthma who are
attempting to purchase cromolyn, to ensure that it is being used for
symptoms of allergic rhinitis.
Antitussives such as dextrome-thorphan (e.g., Delsym,
Robitussin Long-Acting) are used to treat a tight, dry cough, while
expectorants (e.g., guaifenesin in Mucinex) are used to treat a loose,
productive cough. Neither type is to be used for more than 7 days. Both
carry a label warning patients not to use them for a cough that is
chronic, as seen with asthma.6,7 When patients who are known
to have asthma attempt to purchase either type of product, it is wise to
explore the reasons for the proposed purchase.
Various analgesics warn against use in patients with
asthma. Aspirin-containing products (e.g., Bayer Aspirin, Excedrin
Migraine) carry this warning, with an additional allergy alert informing
patients that aspirin can cause a severe allergy reaction that may
include hives, facial swelling, shock, and asthma (wheezing).8
Nonsalicylate analgesics containing ibuprofen (e.g.,
Motrin IB, Advil Migraine), naproxen sodium (e.g., Aleve), and
ketoprofen (no longer readily available as a nonprescription product)
also warn patients to ask a doctor before use if they have asthma.9,10
The allergy alert they carry warns that aspirin-sensitive patients may
have an allergic reaction to the product, which manifests as facial
swelling, asthma (wheezing), shock, skin reddening, rash, and/or
Wheezing Warnings on Nonprescription Products
Wheezing is defined as a high-pitched whistling sound that
is audible when the patient inhales and exhales, caused by air flowing
through constricted airways.11 Wheezing is common with
asthma, so much so that when the FDA requires labels to warn against use
in asthma, the word “wheezing” must follow in parentheses.12
Despite the FDA requirement that asthma and wheezing be
intertwined on some OTC product labels (e.g., salicylates), wheezing is a
component of many other medical problems. They include accidental
aspiration of a foreign object into the lungs, bronchiectasis,
bronchiolitis, bronchitis, emphysema or chronic obstructive pulmonary
disease (COPD, especially when the patient has a respiratory infection),
gastroesophageal reflux, heart failure/cardiac asthma, an allergic
reaction to an insect sting, reactions to medications (e.g., aspirin),
pneumonia, smoking, or a viral infection, especially when the patient is
an infant younger than 2 years of age.11 Since the community
pharmacist is not trained to perform the examination required to
establish a diagnosis, patients with wheezing must be referred.
As mentioned above, salicylates and other nonprescription
nonsteroidal anti-inflammatory drugs (NSAIDs) contain a warning against
use with wheezing, in the context of the constellation of symptoms that
indicate an allergic reaction to the medications. Cromolyn also carries a
label warning against use in wheezing.5 Cromolyn would be ineffective treatment for any one of the multiple causes of wheezing as listed above.
Nonprescription histamine-2 (H2) blockers are
an exception to the other product labels that link wheezing and asthma
together as contraindications to self-use. They do not carry an asthma
contraindication, but all three currently available products (Prilosec
OTC, Prevacid 24HR, Zegerid OTC) carry a specific warning that states,
“Ask your doctor before use if you have frequent wheezing, particularly
with heartburn.”13 This wheezing could be a sign of the problems listed above, as well as an allergic reaction to the H2 blocker.
COPD is one of the most common pulmonary diseases experienced by patients.14,15
Pharmacists can recognize these patients through their profiles, which
may include prescriptions for inhaled bronchodilators (e.g.,
ipratropium, tiotropium, salmeterol, formoterol, albuterol), inhaled
steroids, or other medications such as Singulair or Daliresp.15
Pharmacists are also aware of many of their patients’ smoking
histories. Smoking is the major cause of COPD, so knowledge that a
patient is a smoker can help identify these patients. While some smokers
do not develop COPD, for most there is a direct relationship between
the number of years of smoking, the number of cigarettes smoked daily,
and the risk of developing COPD. The two major subdivisions of COPD are
emphysema and chronic bronchitis, and most persons with a diagnosis of
COPD actually have both.15
Emphysema is diagnosed when patients suffer alveolar damage, reducing oxygenation.14,15
Chronic bronchitis results from continuing irritation and inflammation
of the lining of the bronchial tubes, resulting in long-term cough with a
great deal of mucus produced by the inflammation.16-18 The
diagnosis is made when patients have cough with mucus most days of the
month for 3 months or more. Patients may also complain of chest
discomfort or tightness, fatigue, low fever, shortness of breath that is
worsened by exertion or mild activity, and wheezing.
All first-generation antihistamines carry labeling asking
patients to seek the advice of a physician before use if they have
either emphysema or COPD. Anti-histamines are not considered as a
treatment option for emphysema. A treatment goal in patients with
chronic bronchitis is to loosen mucus so the patient can expel it and
improve airflow.18 Physicians may advise use of steam
vaporizers or prescription medications to help achieve this goal. The
well-known drying effect of first-generation antihistamines could dry
mucus and hamper the patient’s ability to remove it.
First-generation antihistamines are useful in a variety of
OTC products. They relieve the sneezing, rhinorrhea, and nasal itching
of allergic rhinitis.1 Ingredients in these medications
include diphenhydramine (e.g., Benadryl), chlorpheniramine (e.g.,
Chlor-Trimeton), and clemastine (e.g., Tavist Allergy). Patients with
COPD can be advised to avoid these products and choose second-generation
antihistamines, such as loratadine (e.g., Claritin, Alavert),
cetirizine (e.g., Zyrtec), or fexofenadine (e.g., Allegra Allergy).
Three first-generation antihistamines relieve rhinorrhea, nasal itching, and sneezing associated with the common cold.1
They are chlorpheniramine, doxylamine, and clemastine. Once again,
pharmacists should advise COPD patients to avoid these ingredients, but
may suggest use of noncontraindicated cold medications such as nasal
decongestants and sore throat ingredients.
Safe and effective nonprescription motion sickness medications all contain first-generation antihistamines.1
They include dimenhydrinate (e.g., Dramamine), cyclizine (e.g.,
Marezine, Bonine For Kids), and meclizine (e.g., Bonine, Dramamine Less
Drowsy). Pharmacists should advise COPD patients not to use them, and
also to avoid unproven products such as ginger, acupressure bands, and
homeopathics. Rather, patients should be referred to a physician for
consideration of such prescription products as Transderm Scop.
All safe and effective OTC sleep aids contain either diphenhydramine or doxylamine.1
Diphenhydramine is also combined with analgesics such as acetaminophen
(e.g., Tylenol PM). These products are advertised to relieve aches and
pain with accompanying sleeplessness. As there are no other safe and
effective sleep-aid ingredients, pharmacists should also refer COPD
patients with sleep problems to a physician.
Some menstrual products include the first-generation
antihistamine pyrilamine in their formulations to alleviate emotional
changes or mood changes related to premenstrual syndrome (PMS) such as
anxiety, nervous tension, and irritability, and to relieve water
retention, cramps, and backache. Pyrilamine has not been proven safe and
effective for these uses, so pharmacists should advise women with COPD
and PMS to avoid them.
Cough products carry similar warnings. A leading
dextromethor-phan cough suppressant (i.e., Delsym) states, “Ask a doctor
before use if you have chronic cough that lasts as occurs with smoking,
asthma or emphysema, or a cough that occurs with too much phlegm
(mucus).”19 An expectorant product containing guaifenesin
(i.e., Mucinex) adds the words “persistent” to chronic cough and adds
chronic bronchitis as a contraindication for unsupervised self-use.7
If you have asthma, you should not use an anti-allergy product known as NasalCrom
to treat it, as this product is only proven safe and effective for
nasal allergy problems such as hay fever. You should also avoid the use
of cough products for a chronic cough that accompanies asthma, including
such ingredients as dextromethorphan (e.g., Delsym) and guaifenesin
(e.g., Mucinex). Asthma patients also must take care with
nonprescription analgesics. All products containing salicylates (e.g.,
aspirin, Pepto-Bismol) warn against use (without medical advice) by
those with asthma, further cautioning that use can result in a severe
allergic reaction that may include asthma (wheezing). Products with
ibuprofen (e.g., Motrin IB) and naproxen (e.g., Aleve) carry similar
Salicylates, ibuprofen, naproxen, and cromolyn also carry
warnings against use in wheezing. If you have wheezing with heartburn,
you should not use Prilosec OTC, Prevacid 24HR, or Zegerid OTC without
Chronic obstructive pulmonary disease (COPD) is a severe
lung condition that includes emphysema and chronic bronchitis. If you
have any of these diagnoses, you should avoid many nonprescription
antihistamines without a physician recommendation. Antihistamines that
are safe for you are the group that used to be by prescription, but now
can be bought freely, such as Claritin, Zyrtec, and Allegra Allergy.
However, all of the older antihistamines are potentially dangerous, and
you should speak to a physician before using them.
The dangerous group for patients with COPD includes
medications for hay fever, the common cold, motion sickness, sleep, and
menstrual problems. Those for hay fever include diphenhydramine (e.g.,
Benadryl), chlorpheniramine (e.g., Chlor-Trimeton), and clemastine
(e.g., Tavist). These three active ingredients are also found in many
combination products for the common cold, as are other ingredients of
concern such as doxylamine (found in many Nyquil products). Motion
sickness medications to avoid include dimenhydrinate (e.g., Dramamine),
cyclizine (e.g., Marezine, Bonine For Kids), and meclizine (e.g.,
Bonine, Dramamine Less Drowsy). Nonprescription sleep medications to
avoid include doxylamine (as found in some Unisom products) and
diphenhydramine (e.g., Sominex, Nytol, and some Unisom products).
Menstrual products to avoid include any containing pyrilamine, an
antihistamine that does not have any proven effect on either
premenstrual syndrome or menstrual cramps.
Advice for COPD
The majority of patients with COPD got the condition from
repeatedly breathing in irritants that caused the damage. While some
people get COPD from air pollution or the workplace (in jobs such as
coal mining, textile manufacturing, grain handling, and livestock
farming), smoking is the number-one cause of both emphysema and chronic
bronchitis. For this reason, it is vital to stop smoking before the
damage gets even worse. Your pharmacist can help you choose
nonprescription smoking cessation products, such as patches, gum, or
lozenges. If they are not successful, visit your physician for
prescription products such as Chantix that may be more effective.
Remember, if you have questions, Consult Your Pharmacist.
1. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
2. Establishment of a monograph for OTC cold, cough, allergy, bronchodilator and antiasthmatic products. Fed Regist. 1976;41:38312-38424.
3. Cold, cough, allergy, bronchodilator, and
anti-asthmatic drug products for over-the-counter human use; tentative
final monograph for OTC antihistamine drug products. Fed Regist. 1985;50:2200-2218.
4. Cold, cough, allergy, bronchodilator, and
anti-asthmatic drug products for over-the-counter human use; final
monograph for OTC antihistamine drug products; final rule. Fed Regist.1992;57:58356-58376.
5. Nasalcrom Nasal Allergy Spray Product description.
Prestige Brands, Inc.
Accessed May 23, 2012.
6. Robitussin Lingering Cold. Pfizer Consumer Healthcare. www.robitussin.com/products/long-acting-cough#. Accessed May 23, 2012.
7. Mucinex. Reckitt Benckiser LLC. www.mucinex.com/pdfs/mucinex.pdf. Accessed May 23, 2012.
8. Bayer Aspirin. Bayer Healthcare LLC. www.wonderdrug.com/. Accessed May 23, 2012.
9. Motrin IB. McNeil-PPC, Inc. www.motrin.com. Accessed May 23, 2012.
10. Aleve. Bayer Healthcare LLC. www.aleve.com/products.php#caplets. Accessed May 23, 2012.
11. Wheezing. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/003070.htm. Accessed
May 23, 2012.
12. Gern JE. The ABCs of rhinoviruses, wheezing, and asthma. J Virol. 2012;84:7418-7426.
13. Prilosec OTC, Prevacid 24 HR, Zegerid OTC. www.drugstore.com. Accessed May 23, 2012.
14. Emphysema. MedlinePlus. www.nlm.nih.gov/medlineplus/emphysema.html. Accessed May 23, 2012.
15. Chronic obstructive pulmonary disease. PubMed Health. www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001153/. Accessed May 23, 2012.
16. Bronchitis. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/001087.htm. Accessed May 23, 2012.
17. Chronic bronchitis. MedlinePlus. www.nlm.nih.gov/medlineplus/chronicbronchitis.html. Accessed May 23, 2012.
18. What is bronchitis? National Heart, Lung, and Blood
Accessed May 23, 2012.
19. Delsym Adult 12 Hour Cough Liquid (Orange Flavor).
Reckitt Benckiser LLC.
Accessed May 23, 2012.
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