The U.S. Food and Drug Administration (FDA) has told Pfizer Pharmaceuticals
to cease distribution immediately of a direct-to-consumer advertisement for
the company's serotonin reuptake inhibitor antidepressant, sertraline
(Zoloft), because it does not carry the proper warning information.
In a May 6 letter, officials in the FDA's Division of Drug Marketing,
Advertising, and Communications targeted a print ad for Zoloft that ran in the
New York Times on October 24, 2004. That ad, the FDA said, "is
false or misleading because it omits important information relating to the
risk of suicidality in patients taking Zoloft, in violation of [federal law
and] FDA regulations. This ad is concerning from a public health perspective
because it fails to include a serious risk associated with the
The Zoloft ad features an apparently depressed-looking animated character
with sad eyes and frowning mouth. The caption reads, "If this is how you
feel, this is what could help," referring to a CD-ROM in a Zoloft case.
The consumer is then invited to call a toll-free number or visit a Web site to"
get a free info kit with CD-ROM."
The ad includes appropriate notation, required by FDA regulations, telling
consumers exactly what the product has been approved to treat—in this
case, depression in those aged 18 or older. The ad also includes the sentence,"
Side effects may include dry mouth, insomnia, sexual side effects,
diarrhea, nausea, and sleepiness." The ad goes on to say, "In
studies, few people were bothered enough by side effects to stop taking
The problem, according to the FDA, is that the Zoloft ad contains
information from an outdated package insert (PI). "The brief summary
page of the ad," the FDA noted, "is excerpted from an outdated
September 2003 PI, rather than the most current version of the PI as of the
time the ad was run...."
Last fall the Zoloft PI was changed to include a warning that"
patients being treated with antidepressants should be observed closely
for clinical worsening and suicidality, especially at the beginning of a
course of drug therapy, or at the time of dose changes, either increases or
The revised label also includes a reminder that families and caregivers of
patients taking the medication should be alerted to look for emergence of"
agitation, irritability, and other symptoms," as well as"
the emergence of suicidality, and to report such symptoms immediately
to health care providers."
The FDA told Pfizer to stop using the ad or promotional materials similar
to it and to submit a written response to the agency describing the company's"
intent to comply with this request."
Pfizer did not respond to requests by Psychiatric News for
The warning letter comes at a time when the FDA is stepping up enforcement
actions on product marketing, especially regarding direct-to-consumer (DTC)
advertising. The agency is also aiming to make DTC ads more easily
understandable and straightforward.
In April Thomas W. Abrams, R.Ph., director of the FDA's Division of Drug
Marketing and Communications, told a meeting of pharmaceutical company medical
liaisons, "Consumers ignore the presentation of adverse effects in print
advertisements and TV commercials. We have got to get people to pay attention,
and one way to do that is to have headlines and a question-and-answer format
so that it is more appealing."
That approach is already being piloted in television ads for certain
products, such as birth-control pills.
"We have to ensure that the complete picture of a drug is conveyed
and get more useful information about drugs and diseases to the American
public," Abrams said.