there is no international drug testing protocol, but the FDA, severely under-funded at present, approves drugs for certain uses at certain doses, but this leaves MD's in the US free to prescribe for "off-label" uses and at times higher doses. Any newly introduced drugs is likely to reveal dangerous side effects when taken by larger numbers of people than those in the original tests. I don't see how these dangers can be avoided entirely, but the most careful monitoring would certainly help. 

Best,
Michael

On Aug 25, 2011, at 12:17 AM, Mandi Smallhorne wrote:

> 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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