Factors Affecting Adherence to Governmental Health Warnings and the Case of Over-the- Counter Cough and Cold Medications (OTCCCM) in Children Under Two - Innovation and Marketing in the Pharmaceutical Industry - page 348

12.2 An Illustrative Case: The FDA Warning Against

Over-the-Counter Cough and Cold Medication
in Children Under Age 2

12.2.1 The FDA Warning: Background

The FDA is responsible for ensuring public health and safety, and, like similar
agencies around the world, it does so “by assuring the safety, effi cacy and security
of human and veterinary drugs, biological products, medical devices, food supply,
cosmetics, and products that emit radiation” (FDA 2010 ). While government organi-
zations like the FDA are obligated to provide citizens with guidelines and warnings
about possible health risks, citizens are often free to reject these recommendations.
As part of its broad mission, the FDA often issues warnings about various consumer
products (food, food supplements, makeup, and medications). On June 6, 2011, for
example, it issued fi ve recall, market withdrawal, and safety alerts on nonmedical
products, including a Bratz makeup kit (FDA 2011a ) and Kashi frozen pizzas (FDA
2011b ). Given the wide range of products that may be recalled or pose a risk to con-
sumers, FDA warnings are intended to reach a diverse range of audiences. This
underscores the importance of creating messages that are persuasive and can con-
vince citizens to modify behaviors previously considered risk-free.
Serious adverse events from OTC-CCM are relatively rare: while an estimated 95
million packages are sold each year (Brown 2008 ), approximately 1,500-1,600 children
under 2 were admitted to emergency rooms for OTC-CCM-related issues between 2004
and 2005 (Centers for Disease Control and Prevention (CDC) 2007 ; Schaefer et al.
2008 ). In 2007, the FDA completed a review indicating that between 1969 and the fall
of 2006 there were a total of 54 reported child deaths from decongestants and 69 from
antihistamines, most involving children under 2 (Akhayan-Toysekani et al. 2007 ).
Nonetheless, based on these safety data and the paucity of studies demonstrating effi -
cacy in children under 2, the FDA strongly recommended “that OTC cough and cold
products should not be used to treat infants and children less than 2 years of age because
serious and potentially life-threatening side effects can occur from such use” (FDA
2008 ). In 2008, the Medicines and Healthcare Products Regulatory Agency (MHRA) of
the UK issued similar guidelines discouraging use of OTC-CCM in children under 6.
Given the ubiquity of OTC-CCM use (i.e., millions of bottles sold each year; Brown
2008 ), the FDA and MHRA recommendations attracted much media attention. Having
generated substantial public interest and associated surveys and research, these warn-
ings are prime candidates for examining issues related to adherence.
Were the FDA and MHRA warnings successful? For example, did they reach
their intended audience (i.e., parents of children under 2), and did the recommenda-
tions actually precipitate a change in behavior? Having surveyed some recommen-
dations from the marketing and behavioral decision-making literature on how to
construct an effective warning, we now move on to describe the actual FDA warning.
The original FDA press release (FDA 2008 ) was based on the FDA's review of data
and discussion at a joint meeting of the Nonprescription Drugs and Pediatric