Serzone Withdrawal Insufficient; Complete Ban Needed

[Guest guest]

Don't you just love the last sentence of both paragraphs

2 and 3 ??!! And just what is another " safer and equally

effective antidepressant " ??? Geez.

 

Do fat paychecks make people this delusional......

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May 19, 2004

 

" Serzone Withdrawal Insufficient; Complete Ban Needed "

 

Statement of Dr. Sidney Wolfe, Director,

Public Citizen's Health Research Group

 

Bristol-Myers Squibb (BMS) announced today that as

of June 14, it will no longer ship its widely used

antidepressant nefazodone (Serzone). Although stating

this is being done for " business " reasons, this is

questionable because retail sales of Serzone topped

$100 million in 2003. Perhaps the real reason is the

liver toxicity of the drug, which has brought massive

litigation against the company.

 

There are two serious deficiencies in the action

announced today by BMS: First, because the company

is not ordering a recall of the drug and will merely

stop shipping after June 14, patients will be able to

fill (or refill) prescriptions for many more months

because the drug will still be available in channels

of commerce including wholesalers and retail pharmacies.

The failure to order a recall is irresponsible. BMS

should immediately send letters to all doctors to

facilitate the change to any of a variety of other

safer, equally effective antidepressants.

 

Second, although BMS's Serzone has sold by far the

largest share of nefazodone, generic versions are now

available. The U.S. Food and Drug Administration (FDA)

must force those companies to remove their drugs from

the market. Otherwise, the cases of liver failure,

liver transplant and death will continue with the

generic versions of nefazodone. We strongly urge all

people using either Serzone or generic nefazodone to

contact their physicians about switching to a safer

antidepressant.

 

Public Citizen sued the FDA on March 15 over its

failure to act on a petition we filed a year ago

seeking a ban of nefazodone because it had been

linked to a mounting number of deaths and serious

injuries from liver failure. That petition cited 21

cases of liver failure and 11 deaths between 1994,

when nefazodone was first marketed, and spring 2002.

A supplemental petition, submitted to the FDA in

October 2003, said that from April 1, 2002, through

May 12, 2003, there were 33 additional reports of

liver failure, including nine deaths, for a total of

55 patients with liver failure, including 20 deaths.

 

The liver toxicity dangers of nefazodone are

compounded by the fact that it inhibits a key enzyme

that is involved in the metabolism of about half of

all prescribed drugs, including itself, so nefazodone

increases the toxicity dangers of other drugs a

patient may be taking. Also, by inhibiting this

enzyme, nefazodone can increase its own concentration,

with potentially toxic results.

 

Serzone has not been shown to be more effective in

controlling depression than other drugs in its class.

Nefazodone has already been removed from the market

in Canada and Europe and is being taken off the market

in Australia and New Zealand in May. Since January 2002,

a " black box " warning has been included in its U.S.

packing insert, warning of life-threatening liver damage

and recommending that physicians advise patients to be

aware of signs of liver problems.

 

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