20050324

FDA Safety Labeling Changes: CombiPatch, Antidepressants

Uhhh, I told ya so? Well, generically anyway. I said that 'they' do increase the risk in ALL age groups during periods of fluctuation of systemic levels of the medications. Like when you go on or off the medications.

Of course my info is anecdotal based on my own experiences with it and conversations with others with like experiences.

We all know the sky ain't blue unless you can run consecutive samples thru a spectrophotometer taken on the same day of the year at the same time under identical meteorological conditions at the same lat. long. with all results +/- .04 median.

(geeze! my medscape registration was from my days in Arkansas Technical University thru the University Center in WestArk Community College. My username was easy to recover but the password and email address I'd used was tricky to get. Thanx MedScape!) Here's a FURLed<clip> from medscape resulting from a google alert:

"The analysis revealed that treatment with antidepressants significantly increased the mean risk of adverse events representing suicidality in this population compared with placebo (4% vs 2%) and that this risk was greater during the first few months of
treatment. No suicides occurred in any of the trials.

Although considerable variation in risk was observed among the drugs, the FDA notes that a tendency toward increase was observed for almost all those studied. This trend occurred most consistently in the MDD trials, but it was also present in some trial
s for other psychiatric indications, including OCD and social anxiety disorder.

It is unknown whether the suicidality risk in pediatric patients extends to longer-term use (beyond several months) or to adults."


Members can view the full MedScape article here.

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