Fwd: [SSRI-Research] Antidepressant Drugs and Suicidal/Aggressive Behaviors- Thomas J. Moore

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[sSRI-Research] Antidepressant Drugs and Suicidal/Aggressive Behaviors-

Thomas J. Moore

 

Drug Safety Research

2021 K Street, NW Suite 800 ashington, DC 20006

P 202.530.2348 F 202.263.2336

 

http://drugsafetyresearch.com/downloads/sui_behav_antidep.pdf

 

Special Report

Antidepressant Drugs and

Suicidal/Aggressive Behaviors

 

Thomas J. Moore

Senior Scientist

 

 

January 26, 2004

 

Executive Summary

 

Antidepressant Drugs and Suicidal/Aggressive Behaviors

 

This is a study of adverse event reports of suicidal and aggressive

behaviors in

children and adults associated with the six most commonly prescribed

antidepressant

drugs. The target drugs are: sertraline (Zoloft), paroxetine (Paxil),

fluoxetine (Prozac),

citalopram (Celexa), amfebutamone (Wellbutrin, bupropion), and

venlafaxine (Effexor).

 

Key Findings:

 

• Reports of death, disability and other serious events associated

with six

antidepressant drugs increased by 41% from November 1997 through

December

2002. In that interval, the Food and Drug Administration (FDA)

received 44,026

reports about all types of adverse events that identified as a

suspect one of the six

most commonly prescribed antidepressant drugs.

 

• Overall, the proportion of adverse events reported in children less

than 18 years of

age was about the same as expected from the medical use of

antidepressants in

this population group. Children accounted for 5.2% of all reported

adverse events

and 4.8% of all doctors' office visits in which antidepressant drugs

were

mentioned.

 

• Among all ages, the six target drugs were suspected of triggering

3,309 episodes

of suicide, attempted suicide, or hostile, violent or other abnormal

behaviors. A

total of 353 cases were in children under 18 years of age.

 

• Suicidal/aggressive behaviors were reported in children at more

than twice the

expected rate given the drugs' medical use in this age group.

Suicidal/aggressive

behaviors were also reported more frequently in children when

compared to other

types of adverse events, which were reported in similar proportions

in both adults

and children.

 

• An additional 544 cases involved the suspicion that an

antidepressant drug was

linked to another disorder of mood, potentially dangerous feelings of

euphoria,

grandiosity or mania. Of these cases, 72 were reported in children.

Like

suicidal/aggressive behaviors, mania/euphoria was also reported more

than twice

as frequently as expected in children.

 

• Taken together, suicidal/aggressive behaviors and mania/euphoria

describe

potentially dangerous changes in mood or personality suspected of

being

associated with the six target drugs. In children, such reports

accounted for 24%

of all reported adverse events.

 

• No specific drug emerged as unusually toxic or especially safe. The

percentage of

adverse events reported for each target drug was similar to its

medical use, based

on the results of a companion study.

 

Drug Safety Research 2 Antidepressants and Suicidal/Aggressive

Behaviors

 

• The FDA or the manufacturer has previously warned doctors that

clinical trials in

children showed unexpectedly high numbers of suicidal or hostile

behaviors for

two of the target drugs, paroxetine (Paxil) and venlafaxine

(Effexor). However,

these data showed similar results for the two drugs with warnings

about risks in

children, compared to those without such warnings.

 

Conclusions

 

The higher than expected numbers of suicidal and aggressive behaviors

observed

in some clinical trials of antidepressants in children also can be

seen in spontaneous

adverse event data, and add substantial additional evidence to the

case. The data show

that suicidal/aggressive behaviors are reported in both adults and

children, but more

than twice as often in children. Finally, while two drugs now carry

warnings about

this risk, similar risks were reported for the four drugs without

warnings. Findings

from these adverse event data should be interpreted in context with

other scientific

evidence, and with consideration of the limitations outlined below.

 

Limitations

 

Reporting of drug adverse events in the U.S. is entirely voluntary

for consumers

and health care professionals, and only a small fraction of all

events are ever reported

to the FDA. Drug manufacturers must report all serious adverse events

of which they

become aware (typically from consumers or health care professionals)

but are not

required to monitor safety systematically. The reporting of an

adverse event

typically establishes that an observer suspected the drug was

responsible, but does not

in itself establish that the drug caused the event reported.

Variation in adverse event

reporting rates can occur for reasons unrelated to the safety of the

target drug.

 

Financial Disclosure

 

This study was supported by an unrestricted grant from Andy Vickery,

a Houston

trial lawyer who represents families in lawsuits against

pharmaceutical

manufacturers.

 

SSRI-Research/

 

 

 

 

 

 

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