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Respiratory Problems and Nonprescription Products

W. Steven Pray, PhD, DPh
Bernhardt Professor, Nonprescription Products and Devices
College of Pharmacy
Southwestern Oklahoma State University

Weatherford, Oklahoma

Gabriel E. Pray, PharmD Candidate
College of Pharmacy
Southwestern Oklahoma State University

Weatherford, Oklahoma



7/18/2012

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 blisters.

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 Warnings

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

PATIENT INFORMATION


Asthma Warnings

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 warnings.

Wheezing Warnings

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 physician approval.

COPD Warnings

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.

REFERENCES

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. http://nasalcrom.com/~/media/files/nasalcrom/nasalcromproductinformation.pdf. 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 Institute. www.nhlbi.nih.gov/health/health-topics/topics/brnchi/. Accessed May 23, 2012.
19. Delsym Adult 12 Hour Cough Liquid (Orange Flavor). Reckitt Benckiser LLC. www.delsym.com/docs/Adult-12-Hour_Cough_Liquid_Grape_Drug_Facts.pdf. Accessed May 23, 2012.

To comment on this article, contact rdavidson@uspharmacist.com.

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