2006N-0414

Suicidality Data from Adult Antidepressant Trials

FDA Comment Number :

EC41

Submitter :

Mrs. Cathy Harter

Date & Time:

12/01/2006 09:12:45

Organization :

Mrs. Cathy Harter

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

My name is Cathy Harter. I urge you to please listen to the story of my son Stephen, who was only 19 years old when he committed suicide from what I firmly believe was a direct result of his ingestion of Paxil.

In September 2004, my son, Stephen Harter, was given office samples of Paxil from his family physician. While he had a history of mild/moderate anxiety and depression, mostly associated with the ups and downs of typical teenage relationships, in September 2004, his family physician diagnosed Stephen as having mild depression/anxiety and concluded that he was neither suicidal nor thinking of suicide. His physician never warned Stephen or me that Paxil could actually cause suicidal thinking or agitation that could lead to suicide.

On September 26, 2004, after taking Paxil for what I believe to be less than 1 week, our son had committed suicide. During the investigation that took place in our home, the coroner asked me if Stephen was on any medication. I explained that he had recently started taking Paxil. She wanted to know when he started taking the medication, what his dosage was and if he complained of any side effects. Her questions led me to ask her if Paxil could have caused our son to do this; she responded yes, it is possible.

On the day Stephen committed suicide, he was exhibiting symptoms of what I now understand to be called akathisia, which can lead to suicide. Within days of ingesting Paxil, Stephen was acting very irrationally. If I had only known that this drug can cause this type of behavior, I could have done something and Stephen would be alive today.

There is no doubt in my mind or belief that my sons death was caused by Paxil. On the day of Stephens suicide, he woke up extremely distraught. He was crying without reason and visibly upset. I sat down with Stephen and tried to understand why he was so upset. He just kept irrationally repeating that his girlfriend was not answering the phone. I tried to explain to him that it was Sunday afternoon and she probably was not home. Stephens behavior this day was bizarre because, while there had been times in the past where Stephen became depressed when he and his girlfriend had broken-up, there were no problems with his girlfriend at the time and the fact that she did not answer the phone was not unusual. Stephen would never become even remotely upset over his girlfriend not answering the phone. Stephen was exhibiting severe agitation and he could not sit still. He was being irrational to the extreme. While his behavior concerned me, I had no idea that Paxil could actually cause this type of behavior.

Shortly thereafter, I explained to Stephen that I was not feeling well and was going to lie down for a short while. Within the next 30 minutes, Stephen had hanged himself in our garage.

Stephen was an intelligent, loving, caring, respectful individual who had so many dreams for his life. He had just started his second year at Sinclair Community College. He was working toward an Associates degree in Computer Information Systems. His dream was to own his own company.

If I only knew that Paxil could cause suicide, his irrational behavior that day would have been a signal to me that I needed to get him help. It

would have saved the life of our only child.

Respectfully submitted,

Cathy Harter

In Loving Memory of

Stephen Nelson Harter