I find this concerning. Citalopram was launched in 1989 and the patent
expired in 2003. (In South Africa we know it as Cipramil, and I know a
couple of people who have been or are on it.)  What are the rules when a
drug is approved - once it's approved, can higher doses just be suggested
without additional tests to see if they are safe?

Aug. 24, 2011 -- The antidepressant Celexa can cause possibly fatal changes
to the heart's electrical activity, the FDA today warned.
Celexa should no longer be used at doses higher than 40 milligrams per day.
The drug's new label will remove a statement suggesting that some patients
may need 60 milligrams per day. It will also warn of the drug's risk to the
heart.
According to the FDA, Celexa "can cause abnormal changes to the electrical
activity of the heart." These changes, known as prolongation of the QT
interval, can lead to fatal changes in the heart's rhythm.
"Patients at particular risk for developing prolongation of the QT interval
include those with underlying heart conditions and those who are predisposed
to low levels of potassium and magnesium in the blood," the FDA warns.
The higher the Celexa dose, the greater the risk to the heart.
Celexa should no longer be used by people who were born with long QT
syndrome.
Any side effects linked to Celexa should be reported to the FDA's MedWatch
Safety Information and Adverse Event Reporting Program online at
fda.gov/medwatch/report.htm or by phone at 800-332-1088.



 

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