ABSTRACTS

Drug Safety 2008; 31 (10): 885-960

0114-5916/08/0010-0885/$48.00/0
2008 Adis Data Information BV. All rights reserved.

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

Systematic Reviews 2008, Issue 1. Art. No.: CD001831. DOI: 10.1002/

14651858.CD001831.pub