| 2004N-0330 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee | |||||||||||||||||||||||
| FDA Comment Number : | EC13 | ||||||||||||||||||||||
| Submitter : | Mrs. Karen Eagle | Date & Time: | 08/30/2004 02:08:55 | ||||||||||||||||||||
| Organization : | Mrs. Karen Eagle | ||||||||||||||||||||||
| Drug Association | |||||||||||||||||||||||
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| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
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August 23, 2004 To: Psychopharmacologic Drugs Advisory Committee and Pediatric Advisory Committee From: Karen Eagle, On behalf of my daughter, Holly Marie Eagle Re: My daughter, Holly. My name is Karen Eagle. A little over two years ago, my younger daughter Holly who was ten at the time began taking 10mg of Paxil for migraine headaches. At first she seemed to do well on the medication, but after several weeks, she seemed to become easily agitated and irritable. Her neurologist felt it would help to increase her dosage of 15mg. Shortly thereafter, she came to me and told me she was hearing voices in her head to do "bad" things. When I asked her what the voices were saying she explained that it told her to "hurt her sister", and to "kill her dog". One day when I picked her up from playing at a friend's house, the voice in her head told her to "push her friend out of a second story window". Another night when her father and I were in the back yard with her, she told us that the voice was telling her to "pick up the garden hose and wrap it around our necks". Towards the end of May, I got a frantic call from my older daughter Andrea to come home quick, that something was wrong with Holly. I came home to find Holly bleeding from self inflicted cuts in her face. She had become angry at her sister and threw a coffee up at her, hitting her door. The coffee cup broke into several pieces and she began cutting her face with them. When I arrived home she was bleeding and crying. She kept telling me over and over that she wanted to die, that she just wanted to die. She told me that the voice in her head was telling her to stab herself. One day in early June of 2002 she had a visual hallucination. She claimed that she saw the "devil.? She became hysterical and kept saying "don't you see it!, don't' you see it!, its right there!" She then curled put in a fetal position on the floor and started sucking her thumb. I was trying to understand what she was seeing so I handed her a legal pad and I told her to write down what she saw. On every page of that legal pad she wrote "EVIL, EVIL, EVIL." | |||||||||||||||||||||||
| Even though our experience only lasted about two months, I know it will be with us forever. Holly, at the age of twelve, still will not sleep in a bed alone. Sometimes she is even afraid to be in a room by herself. My once independent child is often fearful of the simplest things. She's always afraid that the voices will return to haunt her.
I cannot tell you the stress this put my family under. Paxil is to blame for this. My daughter was taking no other medications and was not being treated for anything other than migraine headaches. As soon as she was off the medicine the voices, hallucinations, and irritable behavior was gone. I had no warning about this medication. Not from the manufacturer, not from the pharmacy, and not from the doctor. Just a small warning label could have saved my family from this terrible stress and heartache. I was helpless to save my child. How could I help her when I didn't even know what was wrong? We MUST do a better job of warning the public of these serious side affects, no matter how remote the possibility. As awful as our experience was, I realize it could have been much worst. I'm thankful that she never followed through with what the voice was telling her to do. I'm very lucky that my daughter is alive today. I know there are many others who are not as fortunate. Thank You. Karen Eagle Allen, TX | ||