NEW YORK -(Dow Jones)- A television advertisement for
GlaxoSmithKline PLC's (GSK) Paxil CR is "false or misleading"
because it suggests that the drug can be used by a broader
range of patients than it is actually approved for, the Food
and Drug Administration said.
In a letter to the company, the agency also said the
advertisements imply that the drug is safer than actually
demonstrated and requested that the company immediately stop
distributing promotional materials for the drug that make
A company representative for wasn't immediately available
"The TV ad suggests that anyone experiencing anxiety, fear
or self-consciousness in social or work situations is an
appropriate candidate for Paxil CR," the agency said in the
letter posted Thursday on the agency's Web site.
Instead, Paxil Controlled-Release, is approved for social
anxiety disorder, or SAD, which is different than the "lesser
degrees of performance anxiety or shyness that do not
generally require psychopharmacological treatment," the FDA
In addition, the television ad fails to communicate the
major risks associated with Paxil, the agency said. It not
only excludes mention of certain side effects, but also
includes "compelling and attention-grabbing visuals" that
distract consumers while risk information is read.
The company was given until June 23 to respond to the FDA
-By Mohammed Hadi, Dow Jones Newswires; 201-938-2007
(END) Dow Jones Newswires