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Nonprescription Products to Avoid With Hypertension

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



2/19/2010

US Pharm.
2010;35(2):12-15. 

Researchers have charted an alarming rise in the number of persons with hypertension. For example, the number rose by 30% from 1994 to 2000.1 The CDC estimated the percentage of noninstitutionalized adults aged 20 years and above with hypertension to be 32%.2 The number of ambulatory visits that have hypertension as the primary diagnosis is estimated to be 40.5 million.2 In 2006, there were 23,855 deaths due to hypertension, or 8 per 100,000 population.2 

The National Institutes of Health has provided this hypertension advice for the lay public: “Most of the time, high blood pressure can be controlled with medicine and lifestyle changes.”3 Of course, this optimistic statement assumes that patients do not unknowingly take any action that would raise their blood pressure. For instance, some nonprescription medications may cause dangerous rises in blood pressure, and the labels reflect that danger by recommending that patients speak to a physician before using them. However, some patients ignore the labels completely. Others may choose to ask the pharmacist about the warning. For this reason, it is important for pharmacists to be aware of which products carry the warning and which alternative products may be recommended. 

Oral Nasal Decongestants

For many years, oral nasal decongestants carried a warning against use if the patient had high blood pressure, unless directed to do so by a physician.4 More recently, labels direct patients to ask a physician before use if the patient has high blood pressure, a somewhat more forceful warning. The ability of decongestants to raise blood pressure (and decongest the nasal passages) flows from their pharmacologic actions as vasoconstrictors. 

Pseudoephedrine’s propensity to raise blood pressure was the subject of a meta-analysis conducted in 2005.5 Investigators confirmed that it caused a small but significant increase in systolic blood pressure, but greater effects when a patient took immediate-release products or higher doses. Pseudoephedrine is a popular decongestant, but products containing it are only available behind the pharmacy counter. This requires contact with a pharmacist and affords the pharmacist an ideal opportunity to ask about labeled contraindications, including hypertension, diabetes, trouble urinating due to an enlarged prostate gland, thyroid disease, and heart disease. Pseudoephedrine is found in Sudafed, as well as many combination products. 

Phenylephrine is the only other oral nasal decongestant known to be safe and effective for nonprescription use. It carries the same warnings as pseudoephedrine. Research on its ability to raise blood pressure is not as extensive as that on pseudoephedrine, but some data can be obtained. For instance, a 5-year-old girl was given a cold preparation containing 1 mg/mL of phenylephrine in a dose of 2.5 mL every 8 hours for 4 days.6 She was found to have a 24-hour blood pressure average of 135/80. The authors noted a “clear relationship” between the medication’s administration and the child’s high blood pressure, and normalization of her blood pressure after the medication was withdrawn. No other cause for her hypertension could be identified. 

Topical Nasal Decongestants

Most topical nasal decongestants also carry the warning against unsupervised use with hypertension. This includes oxymetazoline (e.g., Afrin), phenylephrine (e.g., Neo-Synephrine), naphazoline (e.g., Privine), and l-desoxyephedrine/levmetamfetamine (e.g., Vicks Vapor Inhaler). 

When hypertensive patients request a nasal decongestant, the pharmacist can recommend several alternatives. Propylhexedrine (e.g., Benzedrex Inhaler) is not required to carry a warning against unsupervised use with hypertension and may be effective. Another option is the nasal strip (e.g., Breathe Right). When properly applied, the strip can open the nostrils slightly, and perhaps sufficiently to allow the patient to breathe without use of a pharmacologically active ingredient.

Hemorrhoid Products

Some hemorrhoid products (e.g., Preparation H Hemorrhoidal Ointment) include vasoconstrictors such as phenylephrine to decrease swelling. The possibility of absorbing the ingredient in sufficient amounts to cause a measurable drop in blood pressure is remote when the products are used according to all labeled directions.4 Nevertheless, the labels advise that, if a patient has high blood pressure, the product not be used without first asking a physician. In the interest of patient safety, the pharmacist should recommend a vasoconstrictor-free hemorrhoidal product for hypertensive patients. Such products include Preparation H Anti-Itch Cream with Hydrocortisone and Tucks Hemorrhoidal Ointment. 

Asthma Products

Patients with hypertension may request nonprescription asthma products. Oral asthma sprays contain epinephrine, and oral products for asthma contain ephedrine combined with guaifenesin. Both are poor choices for many reasons. For instance, current asthma guidelines do not recommend oral beta-agonists for the treatment of asthma, recommending inhaled beta-agonists instead.4 Further, when an inhaled beta-agonist is appropriate for asthma, modern practice is to choose a more selective beta-2 ingredient (e.g., albuterol, metaproterenol) that is less likely to produce beta-1 cardiac effects than the less selective ingredients such as ephedrine and epinephrine. Oral asthma products (e.g., Primatene) also contain guaifenesin, but it 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 this ingredient is not approved by the FDA for asthma. While guaifenesin would probably not produce any adverse reactions in the asthmatic, its inclusion is puzzling at best. The best advice a pharmacist can give the patient with hypertension who asks about nonprescription asthma products is to visit their primary care physician for a full medical evaluation and a more appropriate prescription product if indicated. 

Ophthalmic Combination Products

Allergic rhinitis is a condition in which patients exhibit a constellation of symptoms such as rhinorrhea, nasal congestion, nasal itching, paroxysms of sneezing, and ophthalmic itching.4 Many of the symptoms are treatable by antihistamines, which are safe for those with high blood pressure. Some patients find that ophthalmic involvement does not abate, even with use of oral antihistamines in the full recommended dosages. 

In 1995, pharmacists noticed a new group of ophthalmic products moving from prescription to nonprescription status to improve the visual symptoms of allergic rhinitis.4 These antihistamine/decongestant combinations (e.g., Visine-A, Opcon-A, Naphcon-A) contain naphazoline 0.025%-0.03% and pheniramine. There is a possibility that the naphazoline might be absorbed to a sufficient extent to exert vasoactive effects. For that reason, all combination decongestant/antihistamine ophthalmic products carry a label warning patients with high blood pressure to ask a physician before using them. It is a strange and seemingly contradictory regulatory fact that even though the vasoactive ingredient in the combinations is the decongestant, ophthalmic decongestant single-entity products are not required to carry this warning (e.g., Clear Eyes [naphazoline 0.012%], Refresh Redness Relief [phenylephrine 0.12%], Visine Advanced Redness Relief [tetrahydrozoline 0.05%], and Bausch & Lomb Advanced Eye Relief for Redness [naphazoline 0.012%]). The apparent reason is the lower concentration of decongestant in the latter products, but the patient who uses them excessively might still absorb sufficient product to raise the blood pressure. It would be prudent and in the best interests of patients’ health to warn those with hypertension against using them, even though they do not carry a specific warning. 

Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

In 2002, the FDA proposed adding ibuprofen to the list of internal analgesics generally recognized as safe and effective for OTC use (although they had been available for many years under a new drug application).4 The agency observed at that time that ibuprofen can cause an increase in blood pressure in hypertensive patients being treated with diuretics alone or diuretics combined with other agents.7 In 2009, the FDA published a final rule (to be effective in April 2010) requiring all NSAIDs (e.g., aspirin, naproxen) to carry the same warning to speak to the physician before use if the patient has high blood pressure.8 For the hypertensive patient who wishes to treat minor pain, the safest alternative would be to recommend acetaminophen, as it is free of effects on blood pressure. 

Nicotine Cessation Products

The final class of nonprescription medications to require a hypertension warning is nicotine smoking cessation products.4 This group includes nicotine gum (e.g., Nicorette), nicotine patches (e.g., NicoDerm CQ, Habitrol), and nicotine lozenges (e.g., Commit). All warn patients to ask a physician before use if they have hypertension not controlled by medication. The FDA has noted reports of hypertension with their use. The safest option is to refer patients who wish to cease smoking to their physician. 

Advising Those Who Ignore Label Advice

Patients with hypertension may have purchased the above products at a nonpharmacy venue and failed to read or heed the warnings. Eventually, they may notice symptoms or read the label and become alarmed and call for advice. The pharmacist can tell these patients that they should measure their blood pressure immediately or go to an emergency room where an accurate reading can be made and effective countermeasures taken to remedy the situation. Possible signs of hypertension that patients should be made aware of include chest pain, confusion, ear noises or buzzing sounds, irregular heartbeat, nosebleeds, tiredness, and/or visual changes.3 

Alternative Medicine

Patients may ask about the role of alternative medicine in treating hypertension. The answer is simple. Unproven pseudomedicines such as herbs, homeopathics, and dietary supplements (e.g., coenzyme Q10, hawthorn, garlic, Levodyn) should never be used in preference to legitimate medications. Consumers may have noticed assertions about hypertension on the Internet, but they should be cautioned that such recommendations are irresponsible and not to be trusted. 

Nonprescription products are generally safe and effective. However, legitimate nonprescription products carry warnings on the label that must be followed to ensure that they are used safely. This includes warnings about interacting medications, appropriate dosing, when to see a physician, and situations in which you should speak to a physician before using the product. One of the most serious warnings is found on medicines that should not be used in an unsupervised manner if you have high blood pressure. 

What Is High Blood Pressure?

Blood pressure is reported using two figures, the top number (systolic) and the bottom number (diastolic). A normal blood pressure is considered to be 120/80 (“120 over 80”). Readings of 120 to 139 (systolic) or 80 to 89 (diastolic) are referred to as prehypertension. If your systolic blood pressure is consistently above 140 or your diastolic pressure is consistently above 90, you are considered to have hypertension (figures provided by the National Institutes of Health). 

What Are the Causes of High Blood Pressure?

High blood pressure affects many different ages and body types, as well as both genders. It occurs in all races, although it is more common in African Americans. In some patients, the hypertension has no known or identifiable cause; this is called essential hypertension. When caused by a specific habit, condition, or medication, it is known as secondary hypertension. Some of the factors that affect blood pressure are the amount of water and salt you take in and retain daily; the medical health of your kidneys, nervous system, and blood vessels; and the levels of certain hormones. Hypertension is more common in those who smoke, the obese, and those with diabetes mellitus. Other causes of secondary hypertension include anxiety, stress, cocaine use, alcohol abuse, and use of certain nonprescription products such as oral nasal decongestants, nasal sprays or inhalers, combination products for cough, cold, and/or flu, nicotine cessation products, and asthma medications. 

Read the labels of all nonprescription products for warnings about high blood pressure and Consult Your Pharmacist if you have any questions. 

What Can Uncontrolled High Blood Pressure Do?

If the blood pressure rises sufficiently, it can lead to stroke, heart failure, heart attack, and kidney failure. It is vital to keep your blood pressure down, to measure it regularly to monitor your success in doing so, and to make an appointment with your physician to diagnose and monitor elevated blood pressure. 

What About Herbal and Dietary Supplements?

You can read on the Internet or hear advice in health food stores from nonphysicians (e.g., clerks, naturopaths, herbalists, homeopaths, reflexologists, etc.) about dozens of unproven herbs, vitamins, minerals, homeopathic products, and other dietary supplements that promise to help you control your blood pressure. Taking advice from such sources is fraught with danger, as they are not medically licensed to make such recommendations, and there is no OTC product that is proven safe or effective in lowering high blood pressure. Rather, you should seek care from a legitimate health care professional (e.g., MD, doctor of osteopathy [DO], nurse practitioner, or pharmacist). 

Remember, if you have questions, Consult Your Pharmacist. 

REFERENCES

1. Fields LE, Burt VL, Cutler JA, et al. The burden of adult hypertension in the United States 1999 to 2000: a rising tide. Hypertension. 2004;44:398-404.
2. Hypertension. FastStats. CDC. www.cdc.gov/nchs/fastats/
hyprtens.htm. Accessed December 18, 2009.
3. Hypertension. National Institutes of Health. MedLine. www.nlm.nih.gov/medlineplus/
ency/article/000468.htm. Accessed December 18, 2009.
4. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
5. Salerno SM, Jackson JL, Berbano EP. Effect of oral pseudoephedrine on blood pressure and heart rate: a meta-analysis. Arch Intern Med. 2005;165:1686-1694.
6. Morales-Carpi C, Torres-Chazarra C, Lurbe E, et al. Cold medication containing oral phenylephrine as a cause of hypertension in children. Eur J Pediatr. 2008;167:947-948.
7. Food and Drug Administration, HHS. Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; proposed amendment of the tentative final monograph, and related labeling. Fed Regist. 2002;67:54139-54159.
8. Food and Drug Administration, HHS. Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; final monograph. Fed Regist. 2009;74:19385-19409.
9. American Heart Association Forums. http://myportal.americanheart.
org/jiveforum/index.jspa. Accessed December 18, 2009. 

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

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