Get ready for a “black box” warning on Zofran.
The FDA is now recommending ECG monitoring in patients who receive Zofran who have potential “electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.”
After all, Zofran has now gone generic like previous anti-nausea medications that have also received black box warnings. The FDA approved Zofran for use in 1991, meaning that Zofran has been on the market for twenty years.
Now, through diligent research, the FDA has decided that that Zofran may cause QT prolongation — just like most of the other anti-nausea medications. As a result, GlaxoSmithKline has been ordered to perform studies to determine whether Zofran could prolong QT intervals, and, if so, to what extent.
Since the FDA states that it has been performing “ongoing safety studies” … for the past twenty years … why doesn’t the FDA actually publish the results of those safety studies that led to the posting of its alarming “safety notice”?
Now we have one less medication in our armamentarium to treat nausea and vomiting. I suppose we can always give ginger root until that gets a black box warning, too. It’s only been around for a few centuries.
Whoa. I think that my heart just skipped a beat. Reading FDA safety notices may have caused me to have QT prolongation. I think that we need to put black box warnings on FDA safety notices and no one should read them without proper EKG monitoring.
Who do we get to study that?