KH, a 55-year-old woman, presents to the emergency department with nausea, vomiting, and complaints of new-onset flu symptoms over the past several days. Her past medical history is significant for allergic rhinitis and chronic lower back pain secondary to a work-related fall 2 years ago. Her current medications include Norco 5/325 (hydrocodone 5 mg/acetaminophen 325 mg per tablet; two tablets four times daily for pain) and loratadine (10 mg daily). The patient also reported recent use of several over-the-counter (OTC) medications over the past 3 days to treat the new-onset flu symptoms, including Alka-Seltzer Plus Severe Cold + Flu (two tablets every 4 hours during the day) and Tylenol PM (two tablets at bedtime). Her social history is significant for alcohol use (three to four glasses of wine/night). Her vital signs include the following: temperature 99.8°F, blood pressure 132/64 mm Hg, pulse 78 bpm, and respiratory rate 15/min. On physical examination, she had left upper abdominal tenderness with evidence of hepatomegaly and mild scleral icterus. Laboratory data revealed the following: alanine aminotransferase, 527 IU/L (normal 10–35 IU/L); aspartate aminotransferase, 425 IU/L (normal < 35 IU/L); and bilirubin, 2.9 mg/dL (normal 0.1–0.3 mg/dL). What medications do OTC cold and flu preparations typically contain? Which of the OTC medications might have contributed to the patient’s current symptoms?
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, Dietary Supplements & Herbal Medications). In 2016, the American public spent approximately $34 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 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 (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 the public is 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 OTC ingredients for both safety and efficacy. There have been two major outcomes of this review: (1) Ingredients designated as ineffective or unsafe for their claimed therapeutic ...