The Food and Drug Administration warned against prescribing the popular anti-depressant Paxil to children for major depression because the adult drug may increase the risk of suicide or suicide thinking in this age group. The FDA’s warning came a week after British regulators warned about Paxil’s possible risk to children.
The FDA said through a statement posted on their Web site “It is very important that children and adolescents not stop taking Paxil suddenly, as there is a risk of discontinuation effects. Caretakers of children and adolescents currently taking Paxil should consult their doctor to discuss the best course of action.”
“There is no definitive action or even decision about what ought to be done,” said FDA’s Dr. Russell Katz. But “we wanted to let people know” about the possible risk.
Paxil is approved for use in adults for the treatment of a number of psychiatric illnesses, including Obsessive Compulsive Disorder (OCD), MDD, Panic Disorder, Social Anxiety Disorder (SAD), Generalized Anxiety Disorder, and Post-traumatic Stress Disorder. The FDA said there is no evidence that Paxil is associated with an increased risk of suicidal thinking in adults.
The FDA has never approved Paxil for the treatment of MDD or any other indication in children and adolescents under the age of 18.
(via The Associated Press)
19 responses so far ↓
john c kaufman // Jun 24, 2003 at 8:33 pm
i would like a copy of this document sent to me. My address is 1221 leatherwood drive, Clarion Pa.16214
Alicia Gaines // Aug 11, 2003 at 7:52 am
Please send me a copy of this letter.
Katrina Rosiak // Aug 13, 2003 at 8:25 am
Please, Please, Please keep this in mind!!
jean // Aug 22, 2003 at 2:22 pm
If the FDA has not ever approved Paxil for children under 18 years of age, then how can doctors prescribe it to a 10 year old. Isn’t the FDA the final word in when it comes to prescriptions?
D Milton // Aug 23, 2003 at 5:46 pm
My brainless e-wife has my 9 year old on Paxil as a way of controlling her. Broom Hilda thinks its working. I think my daughter is loosing it; gaining a lot of weight, depression, emotional instability, feeling of being worthless, lithargic, mucus membrane irritation of the nose, pains in her lower intestinal area, reduction in short term memory, and sudden losses of energy. I am in process of taking her to Court over this. Wish me luck.
rob shhields // Sep 24, 2003 at 2:00 pm
Has anyone reported side effects from paxil that include hearing loss? Rapid weight gain? Inability to focus on any project for long periods of time? Confusion?
Chris // Dec 9, 2003 at 10:22 am
What about the use of Paxil in children for Obsessive Compulsive disorder? My 11 year old son is talking the liquid form of Paxil for OCD since June and now I am really worried…Any info out there??
Terry Walker // Dec 17, 2003 at 6:52 am
SSRI’s from my research paxil has the worst reputation; cause serotonin syndrome which jumps into Neuroleptic Malignant Sydrome-catatonia, (malignant neoplasms of the brain is how it has been reported to the Ontario, Canada medicare system OHIP billings). When FDA approved it was known that 12 in 10,000 people or 1 in 1000 would be morbidified or would die if it was not dealt with in time. I’m still trying to find a doctor in Toronto whom has enough knowledge to help me GlaxoSmithKline refuses to give me help saying contact your family doctor.
I put my trust in god to help me through this.
tina // Feb 5, 2004 at 7:50 am
I wish my 15 year old never was on paxil she is still depressed
so Im taking her slowly off
And the Doctor will try something else.
Hoping zoloft is better on kids!!
Tina
Teresa // Mar 12, 2004 at 9:13 am
My son has been on Zoloft for depression, and it has been wonderful for him. Please try this before giving up hope. He is now a pleasant, normal, outgoing child again.
cathie // Apr 28, 2004 at 2:51 pm
my nine yr old son was recently prescribed Paxil for depression and OCD.. I was looking up information about this and found all of this really distressing information… is this still the general concensus for Paxil in children.. or is it something else?
I have joint custody and this was done without my consent.. not through a doctor .. through a mental health counselor from the county..and the counselor will not discuss the prescription with me.. only with my ex.. because at the moment the children are in his care.. we share the year.. split in half.. so we are 50/50 on residence.. and 100/100 on well-being as far as the custody arrangements go… so what do I do?
jessica // Jul 20, 2004 at 1:34 pm
I was prescribed Paxil in around February of 1997. I was 20 years old. This so called “adult’s medication” took from a serious unipolar, depressive mood disorder, and brought me deeper and deeper into despair. I eventually attempted suicide, was briefly hospitalized, dropped out of college, and spent the next 2 and a half years recovering. When I left school and found a new doctor, she immediately look me off of it, and I improved dramatically and quickly.
I am infuriated that this drug is being marketed as safe for adults. I have read report after report of how this drug took difficult emotional problems and made them absolutely unbearable. It simply shoud NEVER, EVER be described for people with mood disorders. I urge anyone out there to bear this in mind. It took me a full two and a half years before I could fully function again, and I am still (7 YEARS LATER) in the process of recovering from the emotional upheaval which accompanies a suicide attempt.
becki // Aug 2, 2004 at 11:54 am
My 11 year old son has been on Paxil for a year now and has done wonderfully! What a difference it has made in him, however he has developed shaking and twitching uncontrollably. We see the doc tomorrow, im terrified! Does anyone know if this can be connected to paxil?
Ashton // Aug 7, 2004 at 5:15 pm
yah Rob Shhields,
I have experienced rapid weight gain on paxil. I am 15 yrs old and I weighed 127 lbs wen I started it at 14
and now I am about 178 lbs its so badd.
Tamye // Sep 8, 2004 at 3:32 pm
My son is 11 years old and was put on 12.5mg. of Paxil CR twice a day at the end of May. After about three weeks when we went back to the DR. he was a different kid, so easy to get along with, a whole lot less anger. Well now it has been what about 3 months and he is not my child anymore, he tried to take all of his pills one night, luckily there were only 3 and it just made him lethargic the next day, but we have tried and tried to talk to his psychiatrist and he will not return our phone calls, his nurse says that we will have to make an appt. which is over a month away. Someone, anyone, please help us!!!! Guide us if you know what we can do from here. He also is having the trembling of his hands and feet, and when he has an episode it is like you are looking at a demon and not your own child!!!!!
michelle // Sep 18, 2004 at 4:44 pm
My seven year old was prescribed paxil for treatment of anxiety. Currently the school is having him tested for aspergers syndrome. The first week was okay butnow finishing the second week my son is somebody else. He is so aggressive and goes in to rages for no reason followed by extreme crying jags. I am taking him off immediately as he has only been on for 15 days but am very alarmed. Our doctor felt like he was a good candidate for this medication since I am on it for OCD and depression and it has worked beautifully for me, but horrendsous on my child. Has anyone else noticed this in their child?
k from midlothian // Dec 7, 2004 at 6:40 pm
My son is 9 yrs old & started Paxil today. My husband came home to research & found all of this horrible stuff. My son is on it for anxiety & only 5 mg a day. Advice if I should continue? Please advise…
rdjanis // Jul 21, 2005 at 11:38 pm
Paxil almost destroyed my child. The withdrawal from the drug was horrible, this went un-noticed that it was the med causing her problems. Today med free I finally have my child back.
To withdrawal your children from anti depressants safely visit http://www.paxilprogress.org It was this website that saved my child’s life!
glo jones // Sep 26, 2005 at 4:07 pm
I have recently purchased kevin Trudeau’s book Natural cures-”They” don’t want you to about. It is a HUGE eye opener. I have a 10 year old son on resperdal and am taking him off earlier than planned even though it seems to be working well. Please, please please read this book! Take what you will from it.There is a great deal of apalling info about the FDA, FTC and the pharmaceutical industry in general.We all need to educate ourselves and make better decisions for our health and for our families.
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