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A 74-year-old man presents to his primary care provider for worsening shortness of breath, chest congestion, and symptoms of a severe cold (cough, rhinorrhea, nasal congestion, headache) over the past week. His past medical history is significant for heart failure, hypertension, and hyperlipidemia. His current medications include metoprolol succinate 100 mg daily, candesartan 16 mg daily, bumetanide 1 mg daily, potassium chloride 20 mEq daily, and rosuvastatin 20 mg daily. The patient reports excellent adherence with the prescribed regimen. When queried about the use of non-prescription medication and herbal and dietary supplements he admits to using several over-the-counter (OTC) medications over the past 5 days for his cold symptoms including Alka-Seltzer Plus Cold Formula (2 tablets every 4 hours during the day), Sudafed 24-hour (240 mg once daily), and Aleve PM (2 tablets at bedtime). His vital signs are as follows: afebrile, blood pressure 164/92 mm Hg, pulse 78 bpm, respiratory rate 18/min. On physical examination, an S3 gallop is heard; 3+ pitting edema is noted in his lower extremities, and a chest examination reveals inspiratory rales bilaterally. What medications do OTC “cold” preparations typically contain? Which of the OTC medications might have contributed to the patient’s current hypertension? Can any of these preparations exacerbate heart failure?

In the USA, medications are divided by law into two classes: those restricted to sale by prescription only and those for which directions for safe use by the public can be written. The latter category constitutes the nonprescription, or over-the-counter (OTC), medications. This category does not include supplements (vitamins, minerals, herbals, and botanicals), which are subject to different regulatory requirements (see Chapter 65, Dietary Supplements & Herbal Medications). In 2019, the American public spent approximately $32.2 billion on OTC products to self-manage a wide variety of acute and chronic medical conditions.

It is apparent that many OTC medications are comparable products advertised to consumers in ways that suggest significant differences between them. For example, there are more than 100 different systemic analgesic products, almost all of which contain aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or a combination of these agents as primary ingredients. They are made different from one another by the addition of questionable ingredients such as caffeine or antihistamines; by brand names chosen to suggest a specific use or strength (eg, “women’s,” “migraine,” “arthritis,” “maximum”); or by special dosage formulations (eg, enteric-coated tablets, gel tabs, liquids, orally disintegrating strips and tablets, sustained-release products, powders, seltzers). Generally, a price is attached to all of these features, and in most cases, a less expensive generic product can be equally effective. It is probably safe to assume that consumers are generally overwhelmed and confused by the wide array of products presented and will likely use those that are most heavily advertised.

Since 1972, the US Food and Drug Administration (FDA) has been engaged in a methodical review of ...

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