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SSRI-Research@

Tue, 7 Dec 2004 07:39:42 -0500

Wyeth is evil...

 

" Efexor, which is marketed as Effexor in the United States, may cause

irregular heart rhythms, withdrawal symptoms and have a higher rate of

death

from overdose than similar drugs, British regulators said. The

anti-depressant is the Madison, N.J.-based pharmaceutical company's

best-selling drug.

 

" The United Kingdom's Medicines and Healthcare Products Regulatory Agency

said there should be stronger warnings about withdrawal reactions such as

anxiety and insomnia for all anti-depressant drugs. It also said there

should be a warning that anti-depressants may increase the risk of

suicidal thoughts and self-harm in a small group of people.

 

" A call seeking comment from the U.S. Food and Drug Administration

about the

U.K. decision was not immediately returned Monday. "

 

So finally, after all these years, we get some warning of the very serious

adverse " physical " effects of one of these antidepressants. Continue

to hope

for the warnings on diabetes and hypoglycemia, cancer (although

Effexor is one

that does warn of cancer as a side effect), Cushing's Syndrome, breathing

problems, bone loss, etc., etc., etc.

 

Ann Blake Tracy, Ph.D.,

Executive Director, International Coalition For Drug Awareness

Website: www.drugawareness.org

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

Office: 801-282-5282

 

 

http://www.forbes.com/technology/ebusiness/feeds/ap/2004/12/06/ap1694586.html

 

 

Associated Press

Update 1: Regulators Suggest Restricted Use of Drug

 

12.06.2004, 05:29 PM

 

British regulators recommended Monday that physicians restrict the use of

the anti-depressant Efexor because its use could have side effects for

heart

health and pose other risks that require more careful monitoring than its

competitors. The drug's manufacturer, Wyeth, said it would challenge the

decision, but its shares slipped 3 percent.

 

The United Kingdom's Medicines and Healthcare Products Regulatory Agency

said there should be stronger warnings about withdrawal reactions such

as anxiety and insomnia for all anti-depressant drugs. It also said

there should be a warning that anti-depressants may increase the risk

of suicidal thoughts and self-harm in a small group of people.

 

The recommendations are the result of a British government study

launched 18

months ago to study the safety of anti-depressant drugs known Selective

Serontonin Reuptake Inhibitors, or SSRIs. Last year, as part of that

study,

the British government said that Prozac was the only anti-depressant

suitable

for people under the age of 18.

 

The revelations about Efexor come amid growing concern about drug

safety. In

September, Merck & Co. withdrew its pain reliever Vioxx because it doubled

patients risk of heart attacks and strokes.

 

Efexor, which is marketed as Effexor in the United States, may cause

irregular heart rhythms, withdrawal symptoms and have a higher rate of

death

from overdose than similar drugs, British regulators said. The

anti-depressant is the Madison, N.J.-based pharmaceutical company's

best-selling drug.

 

The agency is recommending that only specialists prescribe Efexor and that

patients should be continually supervised. The drug should also not be

prescribed to patients with heart problems, the agency said.

 

Wyeth said it will challenge the agency's action and urged it to

accept the

company's previous recommendations for labeling, educational

initiatives and

new packaging to reduce the risk of suicide and overdose.

 

" We don't think there is scientific basis for what was done in the U.K., "

said Dr. Joseph Camardo, Wyeth's senior vice president for medical

affairs.

 

Camardo said he expects the company appeal will be heard in January. He

added that the U.S. label details a list of symptoms that patients may

suffer when they stop using the drug. He also said the American label

discloses the

possibility that high doses of the drug can cause irregular heart beat.

 

Camardo worries that the restrictions could hurt patients who need the

drug

because the wait to see a specialist in the U.K. is very long.

 

It is too soon to say whether the actions by British regulators will hurt

Efexor sales. Prudential Equity group LLC analyst Timothy Anderson wrote

that the risk to Efexor isn't really in the U.K., where he expects the

drug to ring up $170 million in sales this year. He's concerned other

countries could also demand more restrictive labeling and that the

news coverage generated by the U.K. ruling could taint consumer

perception in other markets.

 

A call seeking comment from the U.S. Food and Drug Administration

about the

U.K. decision was not immediately returned Monday.

 

Also Monday, investment firm Merrill Lynch downgraded Wyeth to a neutral

from buy because the stock has risen 15 percent since the middle of

the year and

it still faces some uncertainty over the lawsuits from two diet drugs it

withdrew.

 

Wyeth shares slipped $1.29, or 3.1 percent, to end the day at $40.27

on the

New York Stock Exchange.

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