Pfizer Zoloft Warnings to Canadian Doctors Contrast to US

[Guest guest]

SSRI-Research@

Fri, 11 Feb 2005 22:03:04 -0500

[sSRI-Research] Pfizer Zoloft Warnings to Canadian Doctors

Contrast to US - FDA Caves In to Pharma lobbying

 

 

 

 

Pfizer Zoloft Warnings to Canadian Doctors Contrast to US - FDA Caves

In to Pharma lobbying

 

Thu, 10 Feb 2005

 

http://www.ahrp.org/infomail/05/02/10.php

 

The FDA has, once again, quietly colluded with industry, compromising

the safety of children's lives to maintain drug manufacturers' cash flow.

 

After two FDA advisory committee hearings (Feb 2-3 and Sept 13-14,

2004) and independent analyses of the data from 24 clinical trials in

which children were exposed to an SSRI antidepressant, the FDA was

convinced that a causal relationship had been scientifically

established between SSRIs and suicidality (suicide attempts) in

children and adolescents.

 

On October 15, 2004 the FDA issued label warnings to reflect the

scientific evidence, stating:

 

" A causal role for antidepressants in inducing suicidality has been

established in pediatric patients. "

http://www.fda.gov/cder/drug/antidepressants/SSRIlabelChange.htm

 

However, under pressure from the manufacturers of SSRI antidepressants

whose $17 billion dollars in sales began to suffer, the FDA caved in,

and changed the wording. Once again, the FDA is instrumental in hiding

from physicians, parents, the scientifically established fact that the

drugs - not the underlying condition--pose a suicide risk for

children. The omission of this vital information from SSRI drug labels

deliberately misleads the courts as well. [CNN report below]

 

Below, is Pfizer's letter to Canadian physicians acknowledging that

the use of SSRI antidepressants has generated reports - in clinical

trials and post-marketing reports - " in both pediatrics and adults, of

severe agitation-type adverse events coupled with self-harm or harm to

others. The agitation-type events include: akathisia, agitation,

disinhibition, emotional lability, hostility, aggression,

depersonalization. In some cases, the events occurred within several

weeks of starting treatment. "

 

Why has the FDA failed to ensure that US physicians and parents are as

well informed about the hazards of widely advertised drugs as their

Canadian neighbors are?

 

Contact: Vera Hassner Sharav

212-595-8974

 

 

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/zoloft_hpc_e.html

 

Health Canada Endorsed Important Safety Information on ZOLOFT

(sertraline hydrochloride)

 

May 26, 2004

 

Stronger WARNING for SSRIs and other newer antidepressants

regarding the potential for behavioural and emotional changes,

including risk of self- harm

 

Dear Health Care Professional,

 

Pfizer Canada Inc., following discussions with Health Canada, would

like to inform you of important safety information regarding the

possibility that SSRIs (selective serotonin reuptake inhibitors) and

other newer antidepressants may be associated with behavioural and

emotional changes, including risk of self-harm.

 

The new Class warning incorporated in the Product Monograph of ZOLOFT*

(sertraline hydrochloride) capsules is provided below.

 

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND EMOTIONAL

CHANGES, INCLUDING SELF-HARM

 

Pediatrics: Placebo-Controlled Clinical Trial Data

 

Recent analyses of placebo-controlled clinical trial safety databases

from SSRIs and other newer antidepressants suggest that use of these

drugs in patients under the age of 18 may be associated with

behavioural and emotional changes, including an increased risk of

suicidal ideation and behaviour over that of placebo. The small

denominators in the clinical trial database, as well as the

variability in placebo rates, preclude reliable conclusions on the

relative safety profiles among these drugs.

 

Adult and Pediatrics: Additional data

 

There are clinical trial and post-marketing reports with SSRIs and

other newer antidepressants, in both pediatrics and adults, of severe

agitation-type adverse events coupled with self-harm or harm to

others. The agitation-type events include: akathisia, agitation,

disinhibition, emotional lability, hostility, aggression,

depersonalization. In some cases, the events occurred within several

weeks of starting treatment.

 

Rigorous clinical monitoring for suicidal ideation or other indicators

of potential for suicidal behavior is advised in patients of all ages.

This includes monitoring for agitation-type emotional and behavioural

changes.

 

Discontinuation Symptoms

 

Patients currently taking sertraline hydrochloride should NOT be

discontinued abruptly, due to risk of discontinuation symptoms. At the

time that a medical decision is made to discontinue an SSRI or other

newer antidepressant drug, a gradual reduction in the dose rather than

an abrupt cessation is recommended.

 

IIt should be noted that a causal role for SSRIs and other newer

antidepressants in inducing self-harm or harm to others has not been

established. The possibility of a suicide attempt is inherent in

depression and other psychiatric disorders, and may persist until

remission occurs. Therefore, high-risk patients should be closely

supervised throughout therapy with appropriate consideration to the

possible need for hospitalization. The updated warning informs

practitioners that all patients being treated with SSRIs and other

newer antidepressants should be rigorously monitored for clinical

worsening, or onset/ worsening of agitation-type adverse events, or

other indicators of potential for suicidal behaviour.

 

Sertraline hydrochloride is not indicated for use in the pediatric

population.

 

New Information Added to the Consumer Information Section

 

The Consumer Information Section of the Product Monograph has been

updated to reflect this new Class warning, and to advise patients that

treatment with SSRIs and other newer antidepressants is most safe and

effective when there is good communication with the treating physician

about how the patient is feeling.

 

Background

 

In February 2004, a scientific advisory panel set up by Health Canada

was asked to provide the clinical practice perspective on the

pediatric clinical trial safety data, and the spontaneous

post-marketing reports for SSRIs and other newer antidepressants. The

panel agreed that a contraindication was not warranted for these

medications, and supported Health Canada's recommendation for stronger

warnings, while providing suggestions and comments. The record of

proceedings, and other information about the panel, can be found on

Health Canada's website at :

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_ssri_2004-02-20_rop_e.html .

 

Pfizer Canada Inc. continues to work closely with Health Canada to

monitor adverse event reporting and to ensure that up-to-date

information regarding the use of ZOLOFT (sertraline hydrochloride) is

available.

 

The identification, characterization and management of drug-related

adverse events are dependent on the active participation of healthcare

professionals in adverse drug reaction reporting programs. Healthcare

professionals are asked to report any suspected adverse reactions in

patients receiving ZOLOFT (sertraline hydrochloride) directly to

Pfizer Canada Inc. or Health Canada at the following addresses:

 

Pfizer Canada Inc.

Medical Information

P.O. Box 800

Pointe-Claire, Quebec

H9R 4V2

1 800 463-6001

 

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may

call toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp

 

For other inquiries: please refer to contact information.

 

The http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html AR

Reporting Form and the

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html AR

Guidelines can be found on the Health Canada web site or in The

Canadian Compendium of Pharmaceuticals and Specialties.

 

Your professional commitment in this regard has an important role in

protecting the well-being of your patients by contributing to early

signal detection and informed drug use.

 

Any questions from healthcare professionals may be directed to the

Pfizer Medical Information Group at Tel: 1 800 463-6001.

 

Sincerely,

 

original signed by

 

Bernard Prigent, M.D.

Vice President & Medical Director

Pfizer Canada Inc.

 

*Trademark Pfizer Inc.

Pfizer Canada Inc. Licensee

 

FDA backs away from antidepressant warning

Change comes to light during murder trial of teen blaming Zoloft

By Jim Polk

CNN

Wednesday, February 9, 2005 Posted: 4:14 PM EST (2114 GMT)

 

CHARLESTON, South Carolina (CNN) -- The Food and Drug Administration

has backed off its warning that antidepressants such as Zoloft, Paxil

and Prozac can cause suicidal actions among children and teens taking

those prescription drugs.

 

Instead, the FDA, in a revised warning posted last week on its Web

site, changed the wording to say only that the drugs " increased the

risk of suicidal thinking and behavior in short-term studies of

adolescents and children " with depression and other psychiatric disorders.

 

News of the FDA's warning change surfaced Wednesday in testimony here

in the murder trial of 15-year-old Christopher Pittman. The defense

contends Zoloft drove him to kill his grandparents when he was 12.

 

Dr. Steve Romano, a psychiatrist and a vice president of Pfizer, which

makes Zoloft, mentioned the FDA change at Pittman's trial while being

questioned about the company's own clinical trials for Zoloft.

 

Limiting the warning language to a risk seen in studies, rather than

saying the drugs actually could cause suicidal behavior in younger

patients, is a significant retreat for the FDA and came after several

months of lobbying by the pharmaceutical industry.

 

The agency has never approved Zoloft, Paxil or most similar drugs for

use by younger patients with depression. Even so, many doctors

prescribe them for children and teens. Prozac is the only such

antidepressant approved to treat depression in children.

 

The version of the warning that the agency posted on its Web site in

October included this sentence: " A causal role for antidepressants in

inducing suicidality has been established in pediatric patients. "

 

The latest version omits that sentence.

 

The sentence was not part of the boldface black-box warning placed at

the start of the insert that accompanies any prescription, but instead

appeared in the first paragraph of a separate section on " Suicide

Risk " which appeared just below that black box.

 

The replacement sentence, however, appears as the first sentence

inside the black box. That first sentence was broader in the original

version, saying: " Antidepressants increase the risk of suicidal

thinking and behavior in children. " The new version qualifies that by

inserting the phrase " in short-term studies. "

 

Romano acknowledged that the wording change was preceded by an

extended " dialogue " between his drug company and others, and the FDA.

 

Romano was called by the defense in the Pittman case to testify about

suicide-related warnings issued both in Canada and the United States.

 

The FDA never has suggested there is any link between these drugs and

violence against others -- the issue in the Pittman murder trial.

 

The trial is in its eighth day and appears likely to spill over into a

third week, rather than go to the jury by this weekend, as originally

predicted.