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76 Evidences of Efficacy and Safety of
Over-the-Counter Medications for Cough Registered in Brazil: A Challenge to Pharmacovigilance Reis , A MM (1) Figueras A (2) Paulo at Ribeirao Preto, College of (1)University of Sao Nursing, Federal University of Minas Gerais, School of Institut Catala ` de Farmacologia, Pharmacy. (2)Fundacio ` Hospitals Vall dHebron, Universitat Autonoma de Barcelona Background: Almost all people self-medicate with over-the-counter cough medicines (OTC-CM), and many health professionals recommend them as a first-line treatment for common-cold.[1,2] Additionally, a number of cough remedies are formulated as fixed dose combination (FDC) with drugs that do not increase their therapeutic efficacy.[3] Aim: To analyze the level of published evidence on efficacy and safety of OTC-CM registered in Brazil. Methods: A search at the Brazilian National Sanitary Surveillance Agency database was used to identify all drugs for cough registered for OTC use in Brazil, both as a single drug or as FDC of a cough medicine and other active ingredients (Anatomical Therapeutic Chemical [ATC] subgroups RO5C, R05D, and R05F). Codeine was not included as it is a prescription drug. Evidences were searched in clinical trials, metaanalysis and safety studies identified through Medline, the Cochrane Library and SIETES (Essential Information System in Therapeutics and Health, an electronic drug information database in Spanish). Results: In May 2008, 40 different formulations containing at least one cough drug were registered in Brazil. Most of them (62.5%) were marketed as FDC that included accompanying drugs (e.g., expectorants, mucolitics and/or antihistamines). Randomized clinical trials were found for only 3 of these drugs: bromhexin, dextromethorphan and guaifenesin, but no clinical trial with FDC was found. Regarding OTC-AC toxicity, the most severe adverse drug reactions described were serotonin syndrome with dextromethorphan and hypersensitivity with mucolitics.[4,5] A systematic review found no good evidence for or against the effectiveness of OTCCM.[6] Discussion: Generally, drugs are eligible for OTC status if they can be used safely and effectively. The efficacy of cough medicines is unclear, specially regarding FDCs, that have no therapeutic justification.[3] In the absence of benefits, an accurate analysis of the actual toxicity profile of OTC-CM seems mandatory. It should not be forgotten that indiscriminate cough suppression may produce sputum retention that aggravate the patient condition. Recently, Food and Drug Administration advised against OTC cough and cold products use in infants and children under 2 years.[3] Conclusion: The evidence regarding the efficacy of cough medicines available in Brazil is weak due to the lack of good quality research. When the benefits of drugs are not clear, the potential risks should be highlighted, specially if the remedies have an OTC status. Pharmacovigilance of OTCCM should be encouraged in order to know if regulatory actions should be initiated. Conflicts of interest: None declared. References 1. Pratter MR. Cough and the common cold: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(1 Suppl):72S-4S 2. Kelley LK, Allen PJ. Managing acute cough in children: evidence based guidelines. Pediatr. Nurs. 2007; 33(6):515-24 3. Schaefer MK, Shehab N, Cohen AL, et al. Adverse events from cough and cold medications in children. Pediatrics. 2007; 121(4):783-7 4. Thanacoody RHK. Serotonin syndrome. Adv Drug React Bull 2007;243:931-4 5. Anonimo. Reacciones de hipersensibilidad a mucoliticos: un riesgo innecesario y poco valorado. Alerta de Farmacovigilancia 1997;16:21-4 6. Smith SM, Schroeder, K, Fahe T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database of