SSRI Research and Articles

Members of the FDA:

Thank you for giving me the opportunity to speak at today's hearing. I would like the FDA panel to hear how the lack of research into the association of severe agitation, violence and aggression are affecting our children.

I believe, without question, drug companies have known for many years that there is indeed an association of severe agitation, violence and aggression that can lead to the risk of harm to others.

There is data available today showing the link between SSRI's and violence associated with that small population taking anti-depressants.

And many drug companies have taken great care to keep those results a secret.

Luvox and Effexor have now issued warnings of homicidal ideation as a rare side effect; these drugs carry the same warnings as does each and every other SSRI on the market today. There is no comparable difference between the sides effects, therefore all SSRI medications should carry the possible harm to others or homicidal ideation as a rare side effect.

One has to only look at the long list of side effects listed on the medication guide inserts to see that harm to others is a real possibility when a child begins to show signs such as severe agitation, aggression and violence and the medical profession as well as parents deserve to have this information in order to protect their patients and their children.

Pfizer Canada has issued a warning of harm to one self and harm to others saying,

that there are clinical trials 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.

But in American Pfizer states there is no accepted evidence that Zoloft causes such thoughts or behavior and there is no current available data linking SSRI's to increased aggression or violence.

I ask you today (do American families not deserve to have the same information and warnings in order to take precautions , to be aware of the violent changes that can occur from these medications?) .

New studies and clinical trials are desperately needed today on the association into SSRI's and violence. It is reported that there are now 32 million Americans prescribed antidepressants with a population of 4 % who will develop adverse reactions to these medications, this is 1 million time bombs ready to go off at any given time, many who are children and are prescribed anti depressant medications off label and not approved by the FDA.

As of today the FDA has failed to take any action into this issue, giving the American public the impression that the FDA can not or will not act on this danger to our children.

The FDA must remember whose interests it is supposed to protect and to issue a warning of a possible risk of harm to others on medications inserts will protect our children. I hope when looking at this issue the FDA would rather err on the side of our children's safety.

I am also here today to speak on behalf of one child of many who survived the adverse reactions to SSRI's. One of many that want his story heard, that want you the FDA to take the proper action required and include a warning on all SSRI medications of a risk of harm to others.

His name is Christopher Pittman and he could be the poster child on the importance of including in the medication inserts a RISK OF HARM TO OTHERS.

Christopher while being prescribed Paxil and Zoloft suffered adverse reactions and killed two people he loved the most --his grandparents. Christopher was only 12 years old at the time and was prescribed a medication off label and not approved by the FDA.

Christopher's grandparents were handed free samples of a mind altering drug-- with only the instructions written on the outside of a brown paper bag. Had they received a proper medication guide insert, they may have become aware of what was happening to Christopher, when he complained of how the medication was making him feel or that his skin felt as though it were on fire.

Christopher's grandparents Joe and Joy Pittman could be alive today if only they had received the medication guide insert.

We must make sure all vital information is included in the medication inserts given to professionals and parents , vital information needed in order to avoid such tragedies as the Pittman family and the many more families suffering today .

My Suggestions to the FDA

So that other families are saved from the tragedy and heartbreak that Christopher Pittman and his family are enduring today, I urge you to create an independent research program and begin to collect and establish a separate data base on adverse reactions consisting of severe agitation, aggression and violence.

The American consumer needs to be aware that there is a place to report such events therefore, I urge you to require all drug ads to prominently display a 1-800 number where these violent side effects can be reported.

I also urge the FDA to require the drug medication inserts containing all side effects and adverse reactions be printed in a larger format so consumers will have every opportunity to educate themselves on the dangerous side effects that are possible with these drugs.

I urge the FDA to require that all medication inserts be distributed to all juvenile detention centers as well as mental institutes and adult prisons. Many children and adults in the criminal justice system are on SSRI medications and may be having adverse reactions, It is very important that those in charge of these children and adults be aware that their actions may be a symptom of an SSRI and not the child or adult himself. In order to achieve this they too must have the information to offer the best solution to a child or adult in the criminal justice system.

At this time

I would like to show you at a 4 minute video of Christopher. I want you the FDA committee to see this one child of many; they say a picture can tell a thousand words. I hope for our children's safety the FDA will hear Christopher's voice, a child that has been destroyed by a Drug Company's lack of releasing vital information and because the FDA has to this date failed to better warn the public about these dangerous side effects of SSRI's.

No child deserves the life that Christopher Pittman has been handed due to lack of scientific data on homicidal ideation or risk of harm to others, this is a high price a 12 year old child will have to pay for uncertainty, and you the FDA can change that for many children and their families in the future.

Thank you for your consideration of these suggestions I have presented today.

Janet Sisk / Founder/ The Juvenile Justice Foundation