Springtime confusion

Letters to the Editor 627

Springtime confusion: Are consumers getting the right information on how to treat seasonal allergies? To the Editor: The recent article “Sedation and performance impairment of diphenhydramine and second-generation antihistamines: A meta-analysis” strives to give us a good preview of the discrepancy between the sedating and non-sedating antihistamines. Bender et al1 reported diphenhydramine to have lower performance scores as compared to the nonsedating or the second-generation antihistamines; however, they also reported that these comparisons were not consistent. Moreover, when second-generation antihistamines were compared to placebo, a significant sedation effect was reported for the second-generation antihistamines. They concluded in their study that second-generation antihistamines (including products with loratadine) were not completely non-sedating.1 Consequently, it is very important that non-sedating antihistamines display warnings on the labels to take recommended doses, because the non-sedating effect claim is usually valid only when used at the recommended dose.2 The issue is especially of concern when one evaluates the case of over-the-counter (OTC) products containing loratadine, which was the number-one selling prescription medicine for seasonal allergy and is now available to consumers without any prescription or consultation with the physician. An editorial in the same issue by Dr Shapiro3 is an excellent analysis regarding the implications of the study. Dr Shapiro discusses several aspects related to metaanalyses and the financial quandary associated with sedating and non-sedating antihistamines. We applaud Dr Shapiro’s excellent and timely evaluation of these issues. Nonetheless, we would like to highlight some other facts that might have been overlooked. First, even though nonsedating antihistamines cause low sedation, the advertisements for these drugs should carry appropriate warnings related to performance impairment, especially if the dosage regimen is not followed. Because there are 3 products available in the marketplace almost simultaneously, namely Claritin (Schering-Plough), Alavert (Wyeth Consumer), and Tavist ND (Novartis), and many more generics to follow soon, it is imperative that product advertisements clearly indicate to consumers that exceeding the recommended dose could lead to potential harmful effects. It is important that these ads indicate their products contain the same active ingredient too, thus reducing the potential for excessive use of the same active ingredient because of misinformation. Currently the 2 major brands, Claritin and Alavert, are advertising quite aggressively for brand identity without any consideration for potential misunderstanding by consumers. For example, the advertisement for Alavert (both Internet and TV) claims that it is a “new” non-drowsy product for seasonal allergies without any statements mentioning the dosage.4,5 Furthermore, the same advertisement asserts that it provides 24-hour nondrowsy relief, which “even Claritin can’t beat.”5 These advertising statements might lead consumers to believe

Letters to the editor

J ALLERGY CLIN IMMUNOL VOLUME 112, NUMBER 3

628 Letters to the Editor

Letters to the editor

that Alavert is truly a product with different active ingredients as compared to Claritin. Consumers who do not find relief with Claritin might switch or take Alavert simultaneously without considering the fact that it has the same active ingredient. This could lead to either product replacement (switching from Claritin to Alavert) or overdosing (taking Alavert along with Claritin). Because Claritin and Alavert are the 2 major competitors for relief of seasonal allergies, their advertisements should have clear and understandable information without any jargon and potentially confusing claims. Before the much anticipated switch from prescription to nonprescription status, the physician was the decision maker for the suitability of Claritin to be prescribed to patients. With the switch finally taking place, the burden is now on the consumer, who relies on and receives much of their decision-making information through product ads. Consumers should receive accurate information so they can make appropriate product choice and product use decisions. The case in point is that of the information provided on the Internet advertisements for Claritin and Alavert. These ads compare several antihistamines from both the sedating and non-sedating classes.4-6 Ads for both these products lack warnings on proper use of the product and the possibility of sedation if higher doses are used. Furthermore, the study by Bender et al1 reported that reliable distinction measures do not exist, especially when sedation was evaluated. These advertisements clearly state that consumers need not have any restrictions on driving (or restrictions on operating machinery) when using Claritin.6 However, when referring to this warning (driving and operating machinery restrictions), the advertisement just indicates “No Restriction” without clarifying the dose requirements.6 These statements might be misleading for some consumers, who might take higher doses of the drug advertently or inadvertently. Higher doses of loratadine might cause sedation.1,2 The second point we would like to make is that physicians and pharmacists should be aware of the possibility of such product misadventuring by consumers, especially because of the confusion caused by advertisements. Physicians should also be aware of the potential drug interactions caused by the simultaneous use of these OTC products with other prescription or non-prescription medications, especially for patients with comorbidities. Claritin-D (loratadine and pseudoephedrine) tablets are contraindicated in patients with urinary retention or patients receiving monoamine oxidase inhibitor therapy. It is also contraindicated in patients with severe hypertension or severe coronary artery disease.7 Also, patients with liver impairment or renal insufficiency should be given a lower initial dose of loratadine (Claritin or Claritin-D) (10 mg every other day). 7 Physicians should now always ask patients whether they take such OTC products before they make prescribing decisions. For patients who fill prescriptions for certain disease states such as severe hypertension, pharmacists can also be of assistance. Pharmacists should counsel patients when they get their prescrip-

J ALLERGY CLIN IMMUNOL SEPTEMBER 2003

tions filled and inquire with patients regarding OTC medication use before dispensing the prescribed product. There could be instances when the pharmacist might have to call the physician to change the prescribed medication. These new changes in the healthcare professionals’ behavior are also important and required to reduce potential medication error. Finally, we believe that the Food and Drug Administration (FDA) should play a more active role in evaluating ads for products recently switched from prescription to OTC. The FDA could require a probationary period, and during this period they could scrutinize all ads for such products. The probationary period could be 6 months to 1 year. The FDA requires that advertisements of these drugs contain a balance of risks and benefits of the drug and that all the potential risks should be stated clearly.8 The advertisements for these drugs, especially those that were recently switched to the OTC status, should necessarily promote product safety and potential adverse events due to inappropriate product use. Although the FDA insists that the broadcast ads should not be false or misleading,8 the FDA rarely evaluates consumer understanding and perceptions as a result of such ads. Notifications are usually given to manufacturers for broadcasting ads that might be misleading in some aspect or do not comply with the FDA guidance. However, this usually happens after the ads have already been broadcast. The FDA should look into the matter of evaluating ads for products that have been recently switched to OTC status and try to be proactive, because any delay in action might affect many consumers. The FDA should monitor such ads aggressively, especially during this proposed probationary period. The issue gains further importance when drugs such as Claritin, which was the highest selling prescription product used by millions of consumers, are switched from prescription to OTC. Sujit S. Sansgiry, PhD Gauri S. Shringarpure, MS Department of Clinical Sciences and Administration College of Pharmacy University of Houston Texas Medical Center Houston, Tex

REFERENCES 1. Bender BG, Berning S, Dudden R, Milgrom H, Tran ZV. Sedation and performance impairment of diphenhydramine and second-generation antihistamines: a meta-analysis. J Allergy Clin Immunol 2003;111:770-6. 2. OTC loratadine. Med Lett Drugs Ther 2003;45:3-4. 3. Shapiro GG. Antihistamine meta-analysis leaves uncertainty. J Allergy Clin Immunol 2003;111:695-6. 4. The Alavert advantage. Available at: www.alavert.com/chart/index.asp. Accessed April 7, 2003. 5. Introducing Alavert. Available at: www.alavert.com. Accessed April 7, 2003. 6. Claritin vs other brands. Available at: www.claritin.com/content/learn_ about/claritin_products/claritin_tablets_chart.html. Accessed April 7, 2003. 7. Physicians’ desk reference (PDR). 57th ed. Montvale (NJ): Thompson PDR; 2003. 8. FDA finalizes guidance on DTC ads. Am J Health Syst Pharm 1999;56:1815. doi:10.1067/mai.2003.1647