[drugawareness] Glaxo in Trouble AGAIN, This Time With the FDA

[Guest guest]

atracyphd2

Sat, 12 Jun 2004 03:10:22 EDT

[drugawareness] Glaxo in Trouble AGAIN, This Time With the FDA

 

 

Glaxo could not even make it through the week without once again finding

itself in trouble. Lately they can't win for losing! This time they are in

trouble

over their advertising of Paxil CR. The FDA calls it " false and misleading "

because they are suggesting in the ad that the drug be used for conditions

other than it was approved for - what Pfizer was just fined $430 Million for

doing

in pushing their drug, Neurontin, for conditions other than the seizures it

was approved to treat.

 

They are also accused of implying that Paxil CR is safer than it is and there

was not sufficient warnings for adverse reactions. (My question would be,

" When have they ever issued sufficient warnings about Paxil or any other

SSRI? " ).

Not only were they accused of excluding certain warnings but also including

" compelling and attention-grabbing visuals " which distract consumers while

information on the risks is read.

 

Ann Blake Tracy, Ph.D.

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& audio tape on safe withdrawal: " Help! I Can't Get

Off My Antidepressant! "

 

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

 

http://www.smartmoney.com/bn/ON/index.cfm?story=ON-20040611-000382-0908

 

Breaking News

FDA Warns Glaxo Over Paxil

 

· FDA Warns Glaxo Over Paxil

 

 

 

 

June 11, 2004

 

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

inappropriate claims.

 

A company representative for wasn't immediately available to comment.

 

" 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

wrote.

 

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 in writing.

 

-By Mohammed Hadi, Dow Jones Newswires; 201-938-2007