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 349

Advisory Committees on October 18 and 19, 2007. It addressed parents and
caregivers, “recommending 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.” It went on to specify what
medications categories (e.g., decongestants) were subsumed under the recommen-
dation. The stated reasoning of the FDA against use of the medication was twofold.
First, the FDA described the perils of using the medication: “There are a wide vari-
ety of rare, serious adverse events reported with cough and cold products. They
include death, convulsions, rapid heart rates, and decreased levels of conscious-
ness.” Then, the FDA quoted a statement by Charles Ganely, M.D., director of the
FDA's Offi ce of Nonprescription Products, as follows: “The FDA strongly recom-
mends to parents and caregivers that OTC cough and cold medicines not be used for
children younger than 2. These medicines, which treat symptoms and not the under-
lying condition, have not been shown to be safe or effective in children under 2.”
The release then went on to indicate that use of the medication in children ages 2-11
will be determined at a later stage and offered advice for safe usage; for example:
“only use measuring spoons or cups that come with the medicine or those made
specially for measuring drugs.” Finally, the FDA recommended that “anyone with
questions contact a physician, pharmacist or other health care professional to dis-
cuss how to treat a child with a cough or cold.”

12.2.2 Did the Comply with Recommendations

from the Marketing Literature?

The press release used to disseminate the FDA warning, as it appears on the agency's
website, is not written in a vivid, narrative style (though its coverage in the popular
press may have been more vivid). Further, the message is conveyed in a paternalistic
tone, compelling, rather than nudging, parents to avoid administering OTC-CCM to
their children under 2. Based on the marketing literature reviewed above, it may be
more effective for the FDA to disseminate descriptions of vivid case studies illustrating
the detrimental effects of OTC-CCM, thereby exploiting the affect heuristic (Slovic
et al. 2002 ) and targeting the experiential rather than the rational system (Epstein 1994 ;
Loewenstein et al. 2001 ; Slovic et al. 2004 ). We also note that the recommendation
included two reasons for withholding administration of the medication—that it is
neither safe nor effective. The implicit equal weighting of these consequences may
actually have been suboptimal because parents appear to place more weight on safety
(i.e., side effects) than effi cacy (e.g., fever reduction) (see fi ndings described below
from participants in the Miron-Shatz et al. 2010 study). Further, Zhao and Pechmann's
( 2007 ) work also suggests that for a message to be effective, it must be pretested for
attributes that resonate well with the target audience (e.g., social vs. health conse-
quences for adolescents). Finally, the warning did not include suggestions for alterna-
tive means of relieving children's pain and cough, or for reducing fever, potentially
important for minimizing “the present bias” (see above).