As I always want to help people with kids to be informed of health risks, I put up this letter for your information. I hope it will help if and/or hwen such drugs are offered or pushed on you for your kids.
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Caveat Lector-
Of course Prozac is in the same category with the same effects. What is a suicide "gesture?" Is that the same thing as trying to kill yourself? - JR

FDA Statement Regarding the Anti-Depressant Paxil for Pediatric Population
October 2, 2003

TO: All Children’s Administration Staff
Child Placing Agencies
Residential Care Providers

FROM: Ross Dawson, Deputy Assistant Secretary
Children’s Administration

LaVerne Lamoureux, Director
Division of Program and Policy, CA

Nancy Zahn, Director
Division of Licensed Resources, CA

SUBJECT: Concerns Regarding Use of the Antidepressant Paxil in Youth Under Age 18

It has come to our attention that the Food and Drug Administration (FDA) has issued a warning about the use of Paxil for people younger than 18 years of age. Paxil is one of the drugs in a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs) that are used to treat persons suffering from major depressive disorder (MDD), and other disorders. The drug has not been approved by the FDA for pediatric use in treating depression. According to the FDA there currently is "no evidence that Paxil is effective in children or adolescents" with MDD. The only drug approved by the FDA for treating depression in children is Prozac. For some children Paxil may be appropriate.



In June 2003 the FDA warned that patients under age 18 should not take Paxil because of possible increased risk of self-harm and suicidal impulses associated with the drug. The FDA is currently reviewing reports and clinical trials showing an increased risk of suicidal behavior related to the use of Paxil in children and adolescents. Although the FDA has not completed this evaluation, they are recommending that Paxil not be used in the treatment of pediatric MDD.
IT IS VERY IMPORTANT THAT CHILDREN AND ADOLESCENTS DO NOT STOP TAKING PAXIL SUDDENLY!
Paxil can cause significant reactions when being discontinued. Adverse effects include shivering; feeling nauseated, disoriented, or anxious; and, at times, increases in impulsive behavior including suicidal ideation, plan and gestures. The FDA's statement is that "caretakers of pediatric patients already receiving treatment with Paxil for MDD talk to their doctor before stopping use of the drug. Patients should not discontinue use of Paxil without first consulting their physicians, and it is important that Paxil not be abruptly discontinued."


In response to this warning from the FDA, the Children’s Administration is taking the following four actions:


1. The Children’s Administration is directing all children in our care receiving Paxil to have a medical review with the prescribing physician. If the prescribing physician recommends maintenance on Paxil you are to seek a second opinion. To accomplish this we are taking these steps:
A list of children in paid out-of-home care who are taking Paxil has been compiled. The list of children in unpaid relative care will be available soon.
The lists will be provided to the Regional Administrators and Passport nurses.
Passport nurses will use the lists and assist social workers by calling foster parents/caregivers of identified children. They will notify social workers and provide follow-up letters for all children who are contacted.
The Passport nurse will discuss the response to Paxil treatment with the child’s caregiver. If the child’s medication effects or behaviors so indicate, the Passport nurse will ask the caregiver to have the child seen by his or her physician immediately (within one week) to determine whether the child should continue taking Paxil.
When treatment response does not seem to be a problem, the caregiver will be asked to make an appointment with the child’s prescribing physician within 30 days.
If a doctor determines that a child should be gradually taken off Paxil, then the doctor's directions should be followed. Another antidepressant may be prescribed.
If a doctor determines that a child should continue taking Paxil, rather than be transitioned to a different drug, then the social worker should: (a.) get a second medical opinion (this could be based on a paper record and consultation between physicians), and (b.) ask the prescribing doctor to provide an "informed consent" form outlining the potential side effects and risks (this should be signed by the custodian -- parent or Department - and also by children age 13 or older, when appropriate).
If the parent or child refuses to sign the informed consent and it appears, based on medical advice, that Paxil is the only drug recommended for the child, then the social worker should consult with an AAG about asking for a court order.
Social workers should review court orders to ensure that any change in prescriptions is consistent with the court order. If there are inconsistencies, then a hearing should be scheduled to request a change in the court order.


2. There should be no new prescriptions of Paxil for children in the Department’s custody until the FDA clarifies issues with the drug.


Social workers should not consent to, or recommend the court approve any new prescriptions of Paxil for children in the Department’s custody without a second opinion and the approval of the Regional Administrator.


3. Informational letters will be sent to parents of identified children who have been returned home, or are receiving adoption support services.


Letters will be sent from Headquarters to the parents of identified children whose cases are closed, or are receiving adoption support. A copy of the letter will be sent to the region for the child’s file.


4. Attached are an FDA “Talk Paper”, and helpful Questions and Answers on Paxil. This information will also be posted on the foster parent web site.
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