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USP Quality Review

No. 54, Issued 5/96

Product Content Confusion

• A patient with a history of hypertension and coronary disease went to her cardiologist's office in an exacerbated condition. The patient complained of increased headaches, and the cardiologist detected a rise in her blood pressure. Apparently her other physician had advised her to take Chlor-Trimeton to relieve nasal congestion. After purchasing and using the Chlor-Trimeton she felt terrible. Initially, the cardiologist concurred that the Chlor-Trimeton, which contains a single antihistamine ingredient, chlorpheniramine maleate, should be safe for patients with cardiovascular disease. The patient had the Chlor-Trimeton product with her, and when the cardiologist read the label he was shocked to discover that this particular Chlor-Trimeton product contained pseudoephedrine sulfate as the active ingredient--a drug contraindicated for patients with cardiovascular disease. The cardiologist then consulted a drug reference and found that it listed four different Chlor-Trimeton branded products, each with different active ingredients. His patient had purchased Chlor-Trimeton^® Non-Drowsy, which contains pseudoephedrine sulfate and not chlorpheniramine maleate. He then surveyed 100 physicians; only one of them knew that Chlor-Trimeton Non-Drowsy was not a single-ingredient antihistamine product containing chlorpheniramine maleate.

• The brand name Pepto-Bismol^® is widely associated with relief of gastroenteritis. However, the active ingredient in Pepto Diarrhea Control^® is loperamide, an ingredient used to treat diarrhea. A physician and pharmacist together complained that the prominent display of the well-known brand name "Pepto" on the labels of a diarrhea product could be misconstrued by consumers. Consumers might assume that the diarrhea product treats the same symptoms and embodies the same ingredients as those contained in the originally marketed Pepto-Bismol. These health care providers were concerned that patients and consumers who actually need the original Pepto-Bismol for gastroenteritis relief might go untreated if they unknowingly purchase the diarrhea product bearing the "Pepto" name.

• A pharmacist expressed concern that a product called Maalox^® Daily Fiber Therapy does not contain an antacid. Instead, this product is a psyllium-based preparation used to relieve constipation.

• Another pharmacist specifically expressed his concern that many patients might be taking the wrong OTC medications on a daily basis because of confusing names. As an example, he noted that regular Unisom^® contains doxylamine succinate while Unisom^® With Pain Relief^® contains no doxylamine, but rather diphenhydramine and acetaminophen.