1. Karch, Amy M. MS, RN
  2. Karch, Fred E. MD


OTC drugs aren't necessarily 'safe when taken as directed.'


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Pat Miller, a 24-year-old graduate student, is brought to the Student Health Service by her roommate, who found Ms. Miller pale, diaphoretic, confused, drowsy, and disoriented.


Ms. Miller's vital signs are: blood pressure, 100/62 mmHg; pulse, 86 beats per minute; respirations, 20 breaths per minute; and temperature, 97.6[degrees]F. Her throat is dry, swollen, and very red. You note wheezing in the upper airways. Liver palpation produces some guarding, but hepatomegaly is not noted. Ms. Miller is placed on a cardiac monitor, revealing occasional premature ventricular contractions. You start an IV with lactated Ringer solution at 100 cc/hour and send for a complete blood count and a routine chemistry profile (SMA 12).


Ms. Miller had been suffering from a bad cold for more than a week. She had called the Student Health Service and was told she probably had a virus and needed to rest, drink fluids, and take an over-the-counter (OTC) decongestant if necessary. Ms. Miller has no significant medical history and doesn't use drugs or alcohol. She reveals that she has been treating her cold with several OTC preparations.



The medications include Tylenol (acetaminophen) and Coricidin Cold & Flu Tablets (acetaminophen, chlorpheniramine), which Ms. Miller took to relieve muscle aches and other cold symptoms. When those didn't help, she added Tylenol Severe Allergy Caplets (acetaminophen, diphenhydramine) to relieve runny nose, itchy eyes, and congestion. She also added Allerest Sinus Pain Formula Caplets (acetaminophen, chlorpheniramine, pseudoephedrine) to relieve sinus pressure and headaches. Then, two days prior, Ms. Miller added Tylenol Flu NightTime Maximum Strength Gelcaps (acetaminophen, diphenhydramine, pseudoephedrine) to help her sleep. Today, she took Vicks Nyquil Liquicaps (acetaminophen, dextromethorphan, doxylamine, pseudoephedrine), because she still was unable to sleep.


Ms. Miller doesn't remember exactly when she took each drug; however, at any given time she was taking as many as three to five of them. She had inadvertently self-administered excessive amounts of several ingredients found in these preparations. Her presenting signs and symptoms suggest early acetaminophen toxicity-nausea, vomiting, anorexia, pallor, confusion, drowsiness, low blood pressure, arrhythmia, and liver tenderness. The excessive amount of diphenhydramine contributed to Ms. Miller's drowsiness, confusion, and diaphoresis and might have triggered wheezing. Chlorpheniramine compounded the drowsiness.


Glucose, electrolyte, and liver functions are normal. Because there's no hepatotoxicity, it's not necessary to administer the acetaminophen antidote, Mucomyst (N-acetylcysteine). Also, gastric lavage is not performed because the last doses were taken more than three hours prior. Ms. Miller recovers and goes home after receiving two liters of fluids.



With the cold and flu season well under way, it's a good time to remind staff and patients of the potential dangers of OTC medications, which are deemed by the Food and Drug Administration to be "safe when used as directed."


Ms. Miller followed the directions on each package very carefully. But she didn't realize that most OTC preparations for cold, flu, and allergy symptoms contain combinations of the same four or five ingredients. Ingredient lists may be difficult to find, read, or understand. Also, because of the many product names and variant packaging, it's easy to think that the medications treat different problems. This can be a significant problem for parents, who might unknowingly provide an overdose to a sick child. Many popular pediatric products are available in differently colored liquids to identify the symptoms that can be relieved, yet the chief ingredients are often the same.


Education and prevention are the best deterrents. Bring several OTC products to a staff conference and have each member identify each one's ingredients. Encourage staff members not to suggest the use of OTC products without ensuring that patients understand the need to check the list of ingredients of each product and know not to combine products containing the same ingredients.