With SSRIs being approved for urinary incontinence, smoking cessation,

weight loss, restless leg syndrome, fibromyalgia, ADHD, etc., etc. this is

INCREDIBLE news!!!! The drug makers are being told that they must watch for

suicidal tendencies and psychiatric reactions to many various medications.

As carloads of us all made that trek cross country in the middle of the

winter four years ago we wondered if it would be worth the effort, after all we

would get only three minutes each to voice our concerns. But at this point it

is clear that it was worth it many times over! Thank you all again for coming

with us and telling the world what these drugs do!! According to this

article you helped make all this happen. Someday we will all know how many lives we

were able to save as a result.

I quote from the New York Times article below: "Makers of drugs to treat

obesity, urinary incontinence, epilepsy, smoking cessation, depression and many

other conditions are being asked for the first time by the drug agency to put

a comprehensive suicide assessment into their clinical trials."

Ann Blake Tracy, Ph.D., Executive Director,

International Coalition For Drug Awareness

Website: _www.drugawareness.org_ (http://www.drugawareness.org/) &

_www.ssristories.com_ (http://www.ssristories.com/)

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

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

Off My Antidepressant!"

Order Number: 800-280-0730

Paragraph 5 reads: "The seeds for the new federal effort were planted four

years ago with the discovery that antidepressants may cause some children and

teenagers to become suicidal. Top agency officials at first discounted the

finding but commissioned researchers from _Columbia University_

(http://topics.nytimes.com/top/reference/timestopics/organizations/c/columbia_university/inde

x.html?inline=nyt-org) ’s department of psychiatry, led by Kelly L. Posner,

to reanalyze the drugs’ clinical trials. This work caused the drug agency and

its experts to view the risk as real."

_http://www.nytimes.com/2008/01/24/washington/24fda.html?hp

_ (http://www.nytimes.com/2008/01/24/washington/24fda.html?hp) F.D.A.

Requiring Suicide Studies in Drug Trials

By _GARDINER HARRIS_

(http://topics.nytimes.com/top/reference/timestopics/people/h/gardiner_harris/index.html?inline=nyt-per)

Published: January 24, 2008

After decades of inattention to the possible psychiatric side effects of

experimental medicines, the _Food and Drug Administration_

(http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_drug_administration/in

dex.html?inline=nyt-org) is now requiring drug makers to study closely

whether patients become suicidal during clinical trials.

The new rules represent one of the most profound changes of the past 16

years to regulations governing drug development. But since the F.D.A.’s oversight

of experimental medicines is done in secret, the agency’s shift has not been

announced publicly.

The drug industry, however, is keenly aware of the change. Makers of drugs

to treat obesity, urinary incontinence, epilepsy, smoking cessation,

depression and many other conditions are being asked for the first time by the drug

agency to put a comprehensive suicide assessment into their clinical trials.

In recent months, the agency has sent letters ­ it would not say how

many ­ to drug makers requiring that they use such a scale. Merck,

Sanofi-Aventis and Eli Lilly are all using a detailed suicide assessment in clinical

trials being conducted now.

The seeds for the new federal effort were planted four years ago with the

discovery that antidepressants may cause some children and teenagers to become

suicidal. Top agency officials at first discounted the finding but

commissioned researchers from _Columbia University_

(http://topics.nytimes.com/top/reference/timestopics/organizations/c/columbia_university/index.html?inline=nyt-org

) ’s department of psychiatry, led by Kelly L. Posner, to reanalyze the drugs

’ clinical trials. This work caused the drug agency and its experts to view

the risk as real.

Then it received an application for rimonabant, a much-heralded obesity drug

developed by the French drug giant, Sanofi-Aventis. As agency medical

reviewers pored over the drug’s clinical trial data, they discovered hints that it

could cause psychiatric problems, too.

Unsettled by their experience with antidepressants, agency reviewers again

mandated the use of Dr. Posner’s system. The assessment found that the drug

doubled the risks of suicidal symptoms. In June, an F.D.A. advisory committee

voted unanimously that the agency reject rimonabant because of its psychiatric

effects, and Sanofi-Aventis withdrew the application although the drug is

sold in Europe.

Just this month, the results of a trial of Merck’s obesity drug, taranabant,

were published showing similar psychiatric problems. Meanwhile, fears have

grown that drugs used to treat epilepsy, seizures and mood disorders may have

similar effects. An extensive examination of these medicines by the drug

agency should be completed this year.

Suddenly, agency officials realized that multiple classes of medicines might

cause dangerous psychiatric problems.

“Clearly we were somewhat surprised when this signal emerged in the

pediatric antidepressant data,” said Dr. Thomas P. Laughren, director of the drug

agency’s division of psychiatry products. “So various groups within F.D.A. are

now looking at suicidality more broadly as a possible adverse event.”

The drug agency’s concerns are consistent with a growing body of research

confirming that behavior is heavily influenced not only by genes but also by

seemingly innocuous changes in body chemistry. Drugs not reaching the brain

were once thought to be largely free of mental effects.

“One lesson from pharmacology is that you can see effects on emotion and

cognition without the drug entering the brain if a drug leads to peripheral

changes in” other chemicals that enter the brain, said Dr. Thomas R. Insel,

director of the National Institute of Mental Health.

Some critics say that the agency’s new-found focus on psychiatric side

effects is long overdue.

“The list of drugs that causes psychiatric problems is a very long one,”

said Dr. _Sidney M. Wolfe_

(http://topics.nytimes.com/top/reference/timestopics/people/w/sidney_m_wolfe/index.html?inline=nyt-per) , director of _Public

Citizen_

(http://topics.nytimes.com/top/reference/timestopics/organizations/p/public_citizen/index.html?inline=nyt-org) ’s health research group.

Medicines to treat acne, hypertension, high cholesterol, swelling,

heartburn, pain, bacterial infections and insomnia can all cause psychiatric problems,

effects that were discovered in most cases after the drugs were approved and

used in millions of patients.

Some drugs cause depression so often that doctors prescribe antidepressants

prophylactically with them.

Among medicines still for sale, the F.D.A. has determined that the drugs’

benefits outweigh their psychiatric risks. Still, the agency now wants to

uncover such problems more reliably and before approval.

There are two reasons that the F.D.A. for years was inattentive to the

psychiatric effects of new medicines. First, distinguishing between mental

problems that spring from a disease and those that result from its treatment is

often difficult. For antidepressants, many researchers suggested that suicidal

behaviors resulted because, as patients’ depression lifted, they suddenly had

the energy to carry out previous suicidal thoughts.

Second, drug side effects are often first identified in clinical trials when

multiple doctors treating hundreds of patients record similar problems in

trial notes. But terms to describe depression or suicidal thoughts can vary

widely, making them hard to discern.

“The whole spectrum of suicidal thoughts, ideation and attempts is much more

difficult to define and study than” other drug problems, said Dr. Eric

Colman, deputy director of the drug agency’s division of metabolic and endocrine

products.

Indeed, the agency’s initial review of the effects of antidepressants in

children was plagued by inconsistent and erroneous observations by

investigators. A 10-year-old boy who tried to hang himself was listed only as having a “

personality disorder,” an overdose of 11 tablets was called a “medication

error” and a girl who slapped herself in the face was labeled as having

attempted suicide.

Dr. Posner’s team spent months reclassifying these events as either a

suicidal symptom or not. The team created a detailed questionnaire called the

Columbia Suicide Severity Rating Scale, now adopted by the drug agency as an often

mandatory test to be used in clinical trials.

The last time one medicine’s side effect led the F.D.A. to broadly

re-examine its drug approval process was in 1992, when it discovered that Seldane, a

popular antihistamine, could cause dangerous heart arrhythmias. Tests revealed

other drugs that could affect heart rhythms, and the agency soon mandated

that nearly all experimental medicines be tested for heart rhythm effects.

Unlike the Seldane example, however, not every experimental drug program

must use the new suicidal symptoms scale. Drug officials said that they looked

at a drug’s molecular structure and its effects in animals before deciding

whether to insist on the new test.

“That’s where it gets tricky,” said Dr. Colman. “It’s difficult to say

where you draw the line.”

But Dr. Posner said in an interview that so many companies and academic

research programs were adopting the suicide questionnaire that she was having

trouble keeping up with the demand for its use. The questionnaire has been

translated into 80 languages, and Dr. Posner has trained scores of teams of

investigators from around the world on how to use it. On Jan. 4 she lectured a

group of investigators at Yale.

Benjamin A. Toll, an assistant professor in the university’s department of

psychiatry, was in the audience and said he planned to use the Columbia

questionnaire in a trial almost immediately.

“It’s much more detailed than what we were doing before,” Dr. Toll said. “

We used to ask, ‘Are you feeling down? Are you feeling sad?’ ”

Dr. Colman said that the new questionnaire, while important, would not end

the uncertainty around suicidal symptoms.

“If a drug makes people depressed but doesn’t make them suicidal, what do

you conclude?” he asked. “There will always be some degree of uncertainty.”