Summary:


http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4065T1.htm


MS. WEBB:  I am here because three years

      ago my daughter was suffering some symptoms that

      the doctor felt represented depression and started

      her on samples of Paxil.  I trusted this decision

      as a mother and based on my medical background as a

      registered nurse.

                Unfortunately, she did have an obvious

      worsening of symptoms.  Were we aware that the

      antidepressant could be the cause of this?  No, we

      were not.  I am here because I agree that the FDA

      needs to require further studies to be done to see

                                                             
      if it is true that certain antidepressants increase

      the risk of suicidality.

                When I learned that I would have the

      opportunity to speak before this committee I wasn't

      sure what I would say.  So, I replayed an audiotape

      of a confrontation with my then 17 year-old

      daughter during the time she was taking these

      antidepressants.  We could not believe the changes

      we saw in our daughter in the very short time she

      had started on the antidepressants.  It was

      unbelievable--the rage, anger, the hostility she

      exhibited that night.  She ended the night by

      cutting her wrist.  Now I am learning that the

      changes we saw in our daughter, more likely than

      not, were the side effects of the antidepressant

      she was taking at the time.

                Yes, we did report a worsening of symptoms

      shortly after she started the Paxil.  The doctors

      only changed her to another antidepressant, Zoloft.

      She then continued to worsen and they continued to

      increase the dosage until she began to further harm

      herself with self-mutilation, cutting, overdose,

                                                           
      numerous things.  We were fortunate to get her help

      in the right environment with counselors who spent

      many hours with the children.  She was taken off of

      the strong antidepressants and, within a short time

      none of the staff could believe she had done while

      she had been on Paxil and Zoloft.  She continued

      there, getting counseling, and returned as the

      child we knew before she took these

      antidepressants.

                Why did we not know about these adverse

      side effects that are now being reported in

      children?  Was it possible the drug companies may

      have been aware of these adverse side effect?  If

      we had known, I believe it is possible that maybe

      my daughter and our family would not have had to go

      through the agony and heartache we went through.

                My daughter is hearing impaired and has a

      cochlear implant, and has worked hard all her life

      to overcome the stigma of being hearing impaired

      and deaf.  It has been hard but she has always had

      a positive attitude.  Now we are sad but also find

      relief in telling her that what she went through

                                                           
      could have been prevented if the drug companies had

      made public these adverse side effects.  Yes,

      relief but, unfortunately, too late.  She now has

      to endure the stigma that mental illness brings to

      those who suffer it.  Luckily, she has shown her

      determination to overcome this, as she did her

      hearing loss.  She is now a junior in college and

      doing great.  Her determination has brought her

      through many obstacles but this was one she should

      not have had to battle.

                Guidelines for the use of antidepressants

      in children should be reevaluated and studies done

      to determine which, if any, are safe for use in

      children.  Thank God, we were able to get my

      daughter help before it was too late.  I am sure

      there are many more children who did not get that

      help and may have succeeded in their suicide

      attempts.  Thank you.