Deseret News (Eli Lilly and Prozac be Damned!)

October 17, 2004

I can't believe ph Glenmullen made this statement about Prozac. Is

there someone who can contact him and find out if he was misquoted?

Prozac only received approval based on very shaky evidence. It should NEVER

have been approved for children.

And, the monitoring guidelines as outlined are inadequate. They don't allow

for monitoring when dosages are changed, or for withdrawal from these drugs.

There is no warning concerning withdrawal effects. Prozac has the longest

half life of all the SSRIS. Therefore, the adverse affects and problems

with withdrawal generally don't show up until long after the children would

no longer be under close supervision...

For your information, I am once again including information on how Lilly was

able to influence the FDA to approve Prozac:

===================================

From: " Dawn Rider " <israelswarrior@...>

comments@...

Subject: Is Prozac Really Safe for Children?

Date: Fri, 20 Feb 2004 06:06:47 -0700

Dear Editor,

In reference to the article:

http://www.globeandmail.com/servlet/ArticleNews/TPStory/LAC/20040220/%20EPILLS20\

/TPHealth

What harm might antidepressants do?

Friday, Feb. 20, 2004

I was discouraged to see, once again, that Prozac is singled out as the only

drug within the SSRI class of antidepressants " proven " safe for children.

For someone who has lost a child due to the adverse effects of Prozac as I

have, this statement jumped out and slapped me in the face, just as every

other media report that states Prozac is safe for children.

I presented my personal testimony to the advisory panel at the FDA hearing,

and I can tell you - there was no shortage of horror stories involving

Prozac, along with the other brain/body damaging psychoactive drugs in

question.

I'd like you to look at the information that is not being reported in the

media and I hope when Canada takes action, Prozac will be included in the

warning issued to medical professionals and patients.

http://cspinet.org/new/pdf/ssri_paper.pdf

In the third paragraph:

The FDA’s approval of fluoxetine (PROZAC) for children was based on two

studies whose outcomes were controversial, even to the FDA reviewers.

According to the report issued by the Center for Drug Evaluation and

Research at FDA, the treatment effect of fluoxetine compared to placebo was

“non-significant” but trended in the direction of favoring the drug in one

trial of 96 patients. Even that trend was based on what the reviewer

considered a low threshold for measuring relief from the symptoms of

depression. A second trial involving 210 youths “did not win on the

protocol specified endpoint.” However, other measures of psychic wellbeing

indicated that about 70 percent of patients improved compared to 60 percent

on placebo. “The sponsor appeared to achieve nominal significance on other

secondary endpoints,” the reviewer noted.

Furthermore, Eli Lilly's new Prozac Fact Sheet sent to UK physicians--but

not to US physicians--states that Prozac is NOT RECOMMENDED FOR CHILDREN for

any indication. For a larger view, please click on the image.

http://www.ahrp.org/risks/ProzacKids1203.html

Sincerely,

Dawn Rider

Utah, USA

President,

A.S.P.I.R.E.

Please see the Eli Lilly and Prozac Petition:

http://www.petitiononline.com/lilpro

==============================================================================

http://deseretnews.com/dn/view/0,1249,595098701,00.html

Saturday, October 16, 2004

FDA wants bold warning on drugs

Antidepressants will carry alert on youths, suicide risk

By Shogren

Los Angeles Times

WASHINGTON ‹ The Food and Drug Administration told drug companies

Friday to put the government's most vivid warning on all antidepressants to

alert doctors that the medications can increase suicidal thought and

behavior in children and teens.

The warning must be printed in bold type and surrounded by a black box

at the top of the labeling instructions provided to doctors. It also must be

included in any advertisements for the widely prescribed antidepressants.

For all the drugs except fluoxetine, marketed as Prozac by Eli Lilly &

Co., the so-called black-box warning will include the precaution that the

drugs have not been approved for use in children because clinical trials

have not shown them to be effective. Prozac is approved for children.

Drug companies also were directed to provide new guides with each

prescription warning patients and their families that the medications can

make children suicidal and advising them to monitor patients taking the

medications day-to-day and report any behavioral changes to doctors. Those

guides should be given to patients with each prescription dispensed by

pharmacies within the next six weeks, FDA officials said.

The decision to require the warning came just a month after two FDA

advisory panels urged the action.

Dr. Kweder, acting director of the FDA's office of new drugs,

said the black-box warning was " one of the best tools we have to get the

message out that these drugs should not be used casually. "

Doctors wrote about 15 million prescriptions for the nine most popular

antidepressants for children and teenagers last year, according to data from

IMS Health, a pharmaceutical information company, and the FDA. Patients

typically receive several prescriptions a year.

The new instructions to doctors will advise them to discuss the

antidepressants with patients and their caregivers before prescribing them,

and to see their young patients face-to-face at least once a week during the

first four weeks of drug treatment and biweekly for the next four weeks.

Some antidepressant manufacturers expressed concern that the black-box

warning would reduce the number of children who will get help from

antidepressants. They stressed that depression is widespread among children

and teens and, if untreated, can result in suicide.

" Our concern is that this warning may discourage physicians from

prescribing antidepressants for children and adolescents who desperately

need treatment and may discourage parents from seeking treatment for their

children, " said Morry Smulevitz, a spokesman for Eli Lilly.

Many child psychiatrists likewise opposed the black-box warning

because they said it would deter parents and pediatricians from giving the

medications to children even in cases in which they were called for.

" Medication can be very effective for some children and adolescents

with depression, " said Dr. Fassler, a child and adolescent

psychiatrist at the University of Vermont.

He pointed to a recent clinical study that found 71 percent of

children taking Prozac responded positively to a combination of the drug and

therapy, while only 43 percent responded positively to therapy alone.

" All treatments have both risks and benefits, " Fassler added. " Parents

need to learn as much as they can about all treatment options and make a

decision that makes sense for their child. "

Doctors who have led the charge to make the FDA restrict usage of the

drugs said the agency had not gone far enough.

" On the one hand I think this is a wonderful historic step forward,

but on the other hand I don't think they're doing enough to protect

children, " said Dr. ph Glenmullen, a Harvard psychiatrist who has

watched patients become suicidal on antidepressants. He said the agency

should have prohibited children from taking all of the drugs except Prozac,

the one drug now approved for use by children. " The risk-benefit ratio

doesn't justify prescribing drugs that can clearly make patients suicidal, "

he said.

The new warnings were hailed by parents whose children committed

suicide while taking antidepressants.

Mark , whose son hanged himself in 1997 a week after starting to

take Zoloft, said he was " grateful that other parents will now have the

warnings that we were denied. "

October 17, 2004