Adult and children on antidepressants should be closely monitored for an increase in depression or the emergence of suicidal thoughts, the Food and Drug Administration said today in a Public Health Advisory.
FDA asked drug makers today to change the labels of 10 antidepressants to include stronger warnings stating that patients taking the drugs can become suicidal. The drugs that are the focus of this new warning are: Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone, and Remeron.
The Public Health Advisory cautions physicians, families and caretakers of patients on antidepressants to pay close attention at the beginning of treatment, or when the doses are changed with either an increase or decrease in medication.
The agency is also advising that these patients be observed for certain behaviors that are known to be associated with these drugs, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania, and that physicians be particularly vigilant in patients who may have bipolar disorder.
FDA said it has been closely reviewing the results of antidepressant studies in children, since June 2003, which appeared to suggest an increased risk of suicidal thoughts and actions in the children given antidepressants.
“However, it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior,” the FDA stressed.
The label changes follow recommendations made by advisors to the FDA last month, which called for stronger warnings to doctors and parents about the need to monitor patients being treated with certain antidepressants.












1 response so far ↓
Katherine D. Murdoch // Sep 1, 2004 at 10:09 pm
I have been a taking Paxil 20mg. for approximately 3 years. I am a 46 year old female who has suffered from chronic panic/anxiety disorder since the age of 24. Over the years,I have been prescribed several other drugs to rectify my disorder, but to no avail. When finally prescribed Paxil, I felt as if my life had been saved. My experience with the drug has been absolutely positive. I would rather have “my right arm cut off” than my Paxil taken away. However, with the new evidence which has been uncovered regarding the GSK “cover-up”, I am having trouble with the confidence I have intrusted to the drug. I am now suffering panic/anxiety over my use and confidence in the drug. Being most disappointed and terrified, I would like to have further knowledge of the studies involved and be readily assured that my taking Paxil can continue without worry. A response would be greatly appreciated and welcomed. Thank you. I am trying to remain,
Yours truly,
Katherine D. Murdoch
229 West Bank Street
Salisbury, NC 28144
704-636-2794
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