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Nonprescription Products and Heart Warnings

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
 



2/18/2011

US Pharm. 2011;36(2):12-15. 

Nonprescription products carry a host of warnings and precautions. Some involve the heart and blood pressure. These warnings are critical for the pharmacist to understand and communicate to the patient during self-care counseling sessions to help avoid harm from use of certain nonprescription products. 

Heart Disease and Blood Pressure Warnings

By far the greatest number of heart-related warnings on nonprescription products advise against medically unsupervised use if the patient has heart disease or hypertension. Numerous products carry both warnings on their labels. They include OTC products for nasal congestion, asthma, hemorrhoids, pain/migraine, and allergic conjunctivitis.1 Products for smoking cessation carry additional warnings for heart patients. Pharmacists can point out alternative products for each minor medical condition that may alleviate the patient’s symptoms without carrying an associated health risk for patients with heart problems. 

Nasal Decongestants

Nasal congestion is a prominent symptom of several common conditions. Nasal decongestants provide symptomatic relief of nasal congestion due to allergies or the common cold. They shrink nasal mucosa through their vasoconstrictor effects. The only two oral ingredients currently available are pseudoephedrine and phenylephrine. Pseudoephedrine sales are limited to pharmacist-only, behind-the-counter status. Although this move was made solely to limit the illicit use of pseudoephedrine in the manufacture of methamphetamine, it offered pharmacists an opportunity to question all potential pseudoephedrine buyers about contraindicated conditions such as heart disease and high blood pressure. Pharmacists should thereby counsel patients with these conditions not to use the ingredient unless a physician has advised them to do so.2,3 

Most topical nasal decongestants (e.g., oxymetazoline, phenylephrine, and naphazoline) also carry the warning against use by patients with heart disease and high blood pressure, due to the possibility that some of the chemical might be absorbed and reach blood levels that would endanger their health.2,3 These products are generally safe and effective when used as directed, but pharmacists should determine at the point of counseling or sale whether the patient has labeled contraindications for their use. 

One nasal decongestant product is not required to carry the obligatory warnings. This is the nasal inhaler ingredient known as propylhexedrine (Benzedrex).3 It is not the optimal choice for patients with heart problems, however, as it shares a risk common to all topical nasal decongestants, that of causing rhinitis medicamentosa, a clinical condition in which the nasal turbinates become progressively more congested as the product is used.1 Patients often overuse the topical nasal inhalers to regain nasal patency, eventually becoming dependent on them and using them for periods of months or years. Additionally, some patients are uncomfortable with inhalers, as they require the user to insert a tube into the nose. Finally, if a single inhaler is used by several family members, the viruses that cause the common cold might be transmitted among the family. 

Pharmacists can recommend alternative nonpharmacologic devices to assist patients with heart disease or hypertension gain nasal airway patency, such as external nasal dilators. The external nasal dilator mechanically opens the nasal passages, as typified by Breathe Right Nasal Strips.4 To use the slender plastic, adhesive-backed strip, patients should first remove any cosmetics or skin oils from the bridge of the nose, allowing the skin to dry. Patients next remove the paper from the back of the strip, exposing the adhesive. They bend the strip and apply it between the bridge and tip of the nose, pressing it into place and rubbing it gently to ensure a tight seal. When the strip is released, it attempts to return to its preapplication state, thereby pulling the nostrils slightly open and allowing the patient to breathe more freely through the nostrils. A newer version of the strip (Breathe Right Advanced) contacts the skin of the nose at four points to better achieve nasal patency.

Asthma Products

Patients with heart disease or high blood pressure may ask the pharmacist about nonprescription asthma products. These contain ephedrine combined with either guaifenesin (tablets) or epinephrine (inhalers).1 Nonprescription asthma tablets and inhalers are poor choices for any patient with asthma. For instance, current asthma guidelines do not ascribe any role to oral beta agonists such as ephedrine for the treatment of asthma, recommending inhaled beta agonists as superior options.1 Further, when an inhaled beta agonist is considered for asthma, current medical practice suggests choosing a more selective beta2 ingredient (e.g., albuterol, metaproterenol), as it is not as prone to produce beta1 cardiac effects as the less selective molecules such as ephedrine and epinephrine. 

The guaifenesin in oral asthma products (e.g., Primatene) is an irrational ingredient. The etiology of asthma includes narrowing of the airways rather than impaired mucokinesis. It is difficult to envision any benefit from an expectorant in asthma, and nonprescription guaifenesin is not considered by the FDA to be safe or effective in asthma. While guaifenesin would probably not produce any adverse reactions in the asthmatic patient, its inclusion is puzzling at best. 

The best advice a pharmacist can give any patient with asthma who asks about nonprescription asthma products is to visit their primary care physician for a full medical evaluation and a more appropriate prescription product when/if indicated. This is doubly important for the patient with heart disease or hypertension, who should be advised stringently against unsupervised use of these products. 

Hemorrhoids

Some hemorrhoid products (e.g., Preparation H Hemorrhoidal Ointment) include vasoconstrictors (e.g., phenylephrine) to decrease swelling. If the patient reads and follows all labeled directions for frequency of use, the possibility of absorbing the ingredient in sufficient amounts to cause a medically significant rise in blood pressure is remote.1 Nevertheless, the products carry a warning against use by patients with heart disease or high blood pressure unless advised to do so by a physician.1,5 The pharmacist should recommend a vasoconstrictor-free hemorrhoidal product for patients with heart disease or high blood pressure, such as Preparation H Anti-Itch Cream with Hydrocortisone or Tucks Hemorrhoidal Ointment. 

Pain/Migraine

Nonprescription aspirin, ibuprofen, and naproxen products also carry a warning against unsupervised use if the patient has heart disease or high blood pressure.6-8 However, other warnings may go further. Nonprescription ibuprofen and naproxen labels also warn that the risk of heart attack or stroke may increase if the patient uses the products in excess of labeled amounts or for a longer period than recommended on the label (i.e., longer than 10 days for pain or 3 days for fever). Labels also warn patients that ibuprofen and naproxen must not be taken “right before or after heart surgery.” Finally, labels of all products warn against use if the patient is taking a diuretic. 

The National Institutes of Health provides further explanation and information regarding the cardiac-related warnings.9 The agency warns patients contemplating using ibuprofen (and, by extension, naproxen) that they raise the risk of heart attack and stroke, either of which can occur without preceding signs or symptoms and both of which can be fatal.9 The agency also advises patients that a specific type of heart surgery about which they should be concerned is coronary artery bypass grafting (CABG). The labeled interaction with diuretics is warranted since the products can raise blood pressure. Further, concomitant administration with some diuretics (e.g., furosemide) may increase the risk of ototoxicity. 

As an alternative, pharmacists can recommend acetaminophen (e.g., Tylenol) for heart patients who have various self-treatable pains or migraine. It carries no warnings regarding the heart or blood pressure. 

Allergic Conjunctivitis

Since vasoconstrictors are known to raise blood pressure and pose a risk to heart patients (even when applied topically), it is difficult to understand why single-entity ophthalmic vasoconstrictor products (e.g., Visine L.R. containing oxymetazoline 0.025%) were not required to carry heart warnings.1,10 It is equally puzzling that, when manufacturers were allowed to market combination products that combined antihistamines and ophthalmic vasoconstrictors for allergic conjunctivitis, the FDA required the addition of heart warnings. Thus, Visine-A, Opcon-A, and similar combinations warn against unsupervised self-use if the patient has high blood pressure or heart disease. It is prudent for the pharmacist to advise all heart patients contemplating the use of single-entity ophthalmic vasoconstrictors to ask their physician before use, especially since the labels carry no warnings. There are no alternative products for alleviating minor red eye. Patients might be advised to simply bear the problem, as most cases are mild and self-limiting. The limit on unsupervised self-use is 72 hours for all patients, so red eye persisting beyond that time would always need to be checked by an eye care professional in any case to rule out serious ophthalmic conditions.1,10 Alternatively, patients might try one of the newer single-entity antihistamine products, such as Zaditor (ketotifen), which are free of cardiac warnings. 

Smoking Cessation

Nicotine cessation products carry warnings against use by patients with heart disease or high blood pressure not controlled by medication, a slight alteration in wording from other nonprescription products.1 They also warn against unsupervised self-use if the patient has recently had a heart attack or experiences irregular heartbeat. The latter are unusual cardiac warnings not seen on other nonprescription products. These warnings are seen on Nicorette Gum, Commit Lozenges, and Nicoderm patches. Heart patients should be advised to only use these products under their physician’s supervision.  Physicians may choose to recommend them, or to prescribe Chantix, Zyban, Nicotrol NS nasal spray, or Nicotrol Inhalers.11 

PATIENT INFORMATION


There are numerous OTC products that are safe for patients with heart problems, and the best advice is to speak with your pharmacist for clarification. You should always remember to read the label of every nonprescription product carefully to look for these warnings. 

Nasal Congestion

You should ask a physician before taking any oral nasal decongestant tablets, capsules, or liquids. The ingredients of concern are pseudoephedrine and phenylephrine (e.g., Sudafed, Sudafed PE). Unless you have spoken to your physician, you should avoid almost all nasal sprays, drops, or inhalers (e.g., Afrin), and also all cough/cold combinations containing a decongestant. A safe option is the external nasal dilator strip (Breathe Right), which gently pulls your nostrils open after it is applied, easing your breathing. It has no effect on patients with heart disease or high blood pressure. 

Asthma

Asthma products (e.g., Primatene tablets and mist) carry a warning against unsupervised use in patients with heart disease and high blood pressure. Unfortunately, there is no safe OTC option for self-treating asthma, and a physician visit for control of the asthma is the safest choice. 

Hemorrhoids

Hemorrhoid products containing phenylephrine should not be used without a physician’s advice. In this case, there are safe nonprescription products that do not contain phenylephrine, but you must check the label closely to be sure you choose one of them. For instance, some Preparation H products contain phenylephrine, while others do not. 

Aches and Pains

You should avoid aspirin, ibuprofen, and naproxen (e.g., Bayer Aspirin, Motrin IB, Aleve) if you have heart disease or high blood pressure. However, acetaminophen (e.g., Tylenol) is safe to use, as long as you carefully follow all label directions (especially dosing) and another label warning does not apply to you.

Allergic Eyes

If you have allergic rhinitis (“hay fever”), you may find that oral antihistamines do not adequately relieve the itching and tearing of your eyes. You may be tempted to try several popular products, such as Visine-A or Opcon-A. However, their labels warn against use if you have heart disease or high blood pressure. You might try Zaditor, as it contains only the safer antihistamine ingredient (ketotifen). 

Smoking Cessation

Nicotine cessation gum, patches, and lozenges (e.g., Nicorette, Commit, Nicoderm) all warn against use if you have heart disease, irregular heartbeat, or high blood pressure not controlled by medication, or have had a recent heart attack. You should visit your physician to explore whether you should take these under medical supervision, or whether a prescription product such as Chantix is preferable. 

Caffeine

Caffeine is found in Vivarin, as well as some combination analgesic products for headache or menstrual pain. It can cause rapid heartbeat and perhaps should be avoided to better ensure your health 

REFERENCES

1. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
2. Cough, cold, allergy, bronchodilator, and anti-asthmatic drug products for over-the-counter human use; tentative final monograph for over-the-counter nasal decongestant drug products. Fed Regist. 1985;50:2220-2241.
3. Final monograph for OTC nasal decongestant drug products; final rule. Fed Regist.
4. Breathe Right. GlaxoSmithKline PLC. www.breatheright.com. Accessed December 29, 2010.
5. Preparation H. Pfizer Consumer Healthcare. www.preparationh.com/
1994;59:43386-43412. hemorrhoid_medications/ ointment.asp. Accessed December 29, 2010.
6. Motrin IB. McNeil-PPC. www.motrin.com/page.jhtml?id=/
motrin/products/1_1_1.inc&sec= warnings. Accessed December 29, 2010.
7. Aleve. Bayer Healthcare LLC. http://aleve.com/tablets.php. Accessed December 29, 2010.
8. Aspirin regimen. Bayer Regular Strength. Bayer Healthcare LLC. www.wonderdrug.com/products/
ar/ar_rsa.htm. Accessed December 29, 2010.
9. Ibuprofen. National Institutes of Health. www.nlm.nih.gov/medlineplus/
druginfo/meds/a682159.html. Accessed December 29, 2010.
10. Visine L.R. McNeil-PPC. www.visine.com/product-visine-
lr. Accessed December 29, 2010.
11. Nicotrol NS and Nicotrol Inhaler. Pfizer, Inc. www.pfizer.com/products/rx/rx_
product_nicotrol.jsp. Accessed December 29, 2010.
12. Your Guide to Lowering Blood Pressure. NIH Pub. No. 03-5232. May 2003. www.nhlbi.nih.gov/health/
public/heart/hbp/hbp_low/hbp_ low.pdf. Accessed December 29, 2010.
13. Licorice. National Institutes of Health. www.nlm.nih.gov/medlineplus/
druginfo/natural/881.html. Accessed December 29, 2010. 

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

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