Serzone & its generics can damage liver

[Guest guest]

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.

[Guest guest]

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.

[Guest guest]

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.

[Guest guest]

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.