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This article was originally published in The Tan Sheet

Executive Summary

SCHERING-PLOUGH's CHLOR-TRIMETON, SANDOZ' TRIAMINIC LINE EXTENSIONS are cited as two instances in which "good labeling practices have not been followed for nonprescription medications" by two Oklahoma health professionals. In a July letter to the editor of the New England Journal of Medicine, Stephen Levine, MD and Terri Barton, PharmD, University of Oklahoma Health Sciences Center, argued that Schering-Plough's Chlor-Trimeton Non-Drowsy product and Sandoz' reformulated Triaminic are misleading because the line extensions are not differentiated from their predecessor products in packaging. In the case of Chlor-Trimeton, Levine and Barton noted that Chlor-Trimeton Non-Drowsy Formula does not contain chlorpheniramine maleate, "even though the brand name Chlor- Trimeton has been used synonymously with the generic name for more than 30 years. The new preparation, in fact, contains 60 mg of pseudoephedrine sulfate." Other than "the addition of the term 'non-drowsy formula' to the label," the two health professionals continued, "there is no clear indication that the product does not contain chlorpheniramine." A consumer could "mistakenly take the 'non- drowsy' preparation without being aware that it contains a sympathomimetic agent that could cause adverse reactions in people with underlying conditions such as coronary artery disease." In response, Schering-Plough maintained in NEJM that all of its line extensions are "clearly labeled with a description of the ingredients and the symptoms they are intended to relieve, in addition to the indications and precautions to ensure proper use." Packaging of Chlor-Trimeton line extensions, the firm said, are "designed to highlight various formulations and assist consumers in choosing the proper product." Regarding Chlor-Trimeton Non-Drowsy Decongestant Tablets specifically, Schering-Plough asserted that "the front panel of the package clearly states that the active ingredient is pseudoephedrine sulfate, designates the product as a decongestant in a large typeface, and highlights the fact that the product relieves nasal congestion." In contrast, the company explained, "the principal panel of the carton of Chlor-Trimeton Allergy Tablets, which contain only chlorpheniramine maleate, describes the product as containing an antihistamine, lists the sole active ingredient and indicates that the product is for relief of sneezing, itchy, watery eyes and itchy throat, and runny nose." Schering-Plough concluded its response by summarizing the rationale for OTC line extensions: "Different types of drug products are commonly offered under a single brand name to meet the varying health care needs of the consumer while reinforcing the quality standard that a consumer has come to associate with that brand name." The Chlor-Trimeton name has been used with decongestant-containing products for more than 15 years, Schering- Plough added, and "our experience with consumers during this period indicates that they are having no serious difficulty in distinguishing the various Chlor-Trimeton products." In addition to Chlor-Trimeton Non-Drowsy Decongestant Tablets, other Chlor-Trimeton line extensions include: Allergy Decongestant Tablets containing chlorpheniramine and pseudoephedrine; Allergy Tablets containing chlorpheniramine; and Sinus Maximum Strength Pain Relief Capsules containing acetaminophen, phenylpropanolamine and chlorpheniramine. With regard to Sandoz' Triaminic, Levine and Barton noted that new preparations of riaminic Syrup and Triaminic Expectorant are "half the strength of the old formulation" but labeling "does not indicate that the new preparation is half the strength of the old one; it states only that the product is 'new and improved.'" Under a settlement with 34 state attorneys general, Sandoz was required to cease "new" and "improved" claims for the reformulated Triaminic due to consumer confusion ("The Tan Sheet" July 5, p. 16). At the time of the settlement, Sandoz declared in a statement that the state AG action was unwarranted and that the company believes it did not act inappropriately in reformulating Triaminic. The label and color of "both the new and the old preparations are essentially identical (except for the fine print listing the ingredients)," Levine and Barton complained. "Since the old preparation is still being sold, we are concerned that some children may accidentally receive twice the recommended dose if the old formulation is used but is thought to be the new one." Sandoz explained in a response to NEJM that it reformulated its Triaminic Syrup and Expectorant products in 1992 because consumer research indicated that "good taste is vital to compliance, especially among children," and that the "only practical way to improve the taste was to decrease the concentration of the active ingredients and, consequently, to adjust the dosing regimen to ensure that efficacy was not compromised." In introducing the new formulations, Sandoz maintained, "we took great care to ensure that the new products could be differentiated from their predecessors" by packaging the new Triaminic in a carton that "clearly emphasized the improved taste and new dosing instructions." The carton also contains a "new dosage chart to both the bottle label and the carton" so that approximately "half of one carton panel is devoted to a description of the dosing requirements," Sandoz pointed out. Each new Triaminic product contains a dosing cup that advises users to "read the label directions," the company added. Studies by Sandoz have found that "99% of Triaminic users read the label when treating their children," the firm concluded. At a recent meeting of the Drug Information Association, Temple University pharmacy professor Michael Cohen echoed the complaints of Levine and Barton by arguing that many OTC line extensions create consumer confusion by using the same brand name for different formulations ("The Tan Sheet" July 19, p. 5). Cohen cited both Chlor-Trimeton Non-Drowsy Decongestant and Sandoz' reformulated Triaminic as potentially confusing line extensions.

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