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A 66-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, drowsiness) over the past week. His past medical history is significant for heart failure, hypertension, and hyperlipidemia. His current medications include metoprolol succinate 50 mg daily, lisinopril 20 mg daily, atorvastatin 20 mg daily, furosemide 40 mg daily, and potassium chloride 20 mEq daily. The patient reports excellent compliance with his prescribed medications but admits to taking several over-the-counter (OTC) medications over the past 5 days for his recent cold symptoms, including Alka-Seltzer Plus Cold Formula (2 tablets every 4 hours during the day), Sudafed (60 mg every 6 hours), and Advil PM (2 tablets at bedtime). His social history is significant for alcohol use (3–4 beers/night). His vital signs include the following: afebrile, blood pressure 172/94 mm Hg, pulse 84 bpm, respiratory rate 16/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? Are any of these preparations implicated in the signs of 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 64). In 2013, the American public spent approximately 33.1 billion on OTC products to medicate themselves for ailments ranging from acne to warts. These products contain approximately 800 active ingredients in various forms and combinations.

It is apparent that many OTC medications are no more than “me too” products advertised to the public in ways that suggest significant differences between them. For example, there are over 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 (“women’s,” “migraine,” “arthritis,” “maximum”); or by special dosage formulations (enteric-coated tablets, geltabs, liquids, orally disintegrating strips and tablets, sustained-release products, powders, seltzers). There is a price 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 the public is generally overwhelmed and confused by the wide array of products presented and will probably use those that are most heavily advertised.

Over the past four decades the FDA has been ...

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