Podcast: Changing FDA Recommendations on Citalopram—Why Now?
Podcast: Changing FDA Recommendations on Citalopram—Why Now?
 | In the summer of 2011, the FDA issued a new recommendation: that “Celexa should no longer be used at doses greater than 40 mg.”1 Dr Steven Moffic recently wrote about that recommendation in one of his blogs on www,PsychiatricTimes.com.2 He commented, “I was caught completely unprepared. Not only had I not heard about the warning directly, but nothing had been mentioned in any of my ongoing sources of clinical information. So, I wondered. . . how did this emerge after citalopram being on the market since 1998? Why, even as recently as 2006, did the STAR*D algorithm put citalopram as the sole recommended initial medication for nonpsychotic depression?”2 Dr Moffic also asked: “Should the warning be taken seriously? Why do so few psychiatrists seem to know about it? And why do we find out about important side effects long after psychiatric medications become available?” Here, Dr. Moffic explores the ramifications. A Tenured Professor of Psychiatry and Behavioral Medicine and Family and Community Medicine at the Medical College of Wisconsin, Dr Moffic recently joined the editorial board of Psychiatric Times. | ||||||
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Click here for Dr Moffic's article on this topic.
References
1. Federal Drug Administration. FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide). August 24, 2011. http://www.fda.gov/Drugs/DrugSafety/ucm269086.htm. Accessed December 22, 2011.
2. Moffic S. What citalopram tells us about prescribing practices. Psychiatr Times. October 2, 2011. http://www.psychiatrictimes.com/blog/couchincrisis/content/article/10168/1965991. Accessed December 22, 2011.
I'm sure the reason for the delayed warning is the ongoing conflict of interest issue with FDA, Big Pharma, AMA and government players all involved in the decision making process of drug approval and which studies get reviewed; initial suppression of negative evidence/studies that later get brought to light perhaps after the new appointment or removal of some key player in the process.My question is if escitalopram should, also, have these same warnings? It's unfortunate that such a common and reasonable concern would not be addressed by the FDA
but that's the problem with an agency that places politics above human lives.