US FDA says Wyeth made false claims about Effexor
Friday March 26, 2004 3:46 pm ET
By Susan Heavey
WASHINGTON, March 26 (Reuters) - The U.S. Food and Drug Administration
(News - Websites) on Friday warned U.S. drugmaker Wyeth (NYSE:WYE - News)
over circulating misleading claims that its antidepressant Effexor
outperforms other popular competitors.
Several print materials, including a journal advertisement, misuse data to
say more patients suffered fewer symptoms of depression with Effexor than
with selective serotonin reuptake inhibitors, or SSRIs, the FDA said.
Wyeth's claim that Effexor is better "has not been demonstrated by
substantial evidence or substantial clinical experience," the FDA said in a
letter to the company. The letter was released to the public on Friday.
Some SSRIs include Pfizer's (NYSE:PFE - News) Zoloft, Eli Lilly and Co.'s
(NYSE:LLY - News) Prozac and GlaxoSmithKline Plc's (London:GSK.L - News)
Effexor falls under a different class of drugs called serotonin and
norepinephrine reuptake inhibitors, or SNRIs. Both groups of drugs block
serotonin, a powerful neurotransmitter that affects mood.
The FDA letter also cited Effexor radio ads for not stating side effects or
specific signs of depression -- including lack of interest, appetite loss
and suicidal thoughts.
"The advertisement fails to communicate important characteristics necessary
to distinguish between major depressive disorder and variations of normal
daily functioning," the FDA said.
The agency gave Wyeth until April 1 to respond to the warning. If the
company fails to act, the FDA can eventually impose fines and other
Wyeth spokesperson Douglas Petkus said the company received the FDA letter
and would work with the agency.
Shares of Wyeth were down 25 cents, or 0.68 percent, to $36.78 in late
afternoon trade the New York Stock Exchange (News - Websites) .