New Lovaza website is up with a couple of warnings. They now have a $20 instant rebate. The warnings read:
- increases in the results of blood tests to check your liver functions (ALT and AST) and your bad cholesterol levels (LDL - C)
- increases in the frequency of a heart rhythm problem (atrial fib. or flutter may especially happen)
If you're a cardiac patient - which many people are taking this medication - I'm not sure you would want heart flutter as a side effect.
So were they required by the FDA to bring back the website with the new warnings? Or does the FDA only have enforcement rights on the label (at the point of sale)? My point is, "What was GSK's reasoning for bringing the website back on line"? Maybe showing disclosure for potential lawsuits? Stirring people away from it's drug? Will we see TV ads now showing possible side effects? Or is this a precursor for the new and improved Lovaza, ie Vascepa.