FDA requires all SE's listed in PI's that are 3% greater than placebo for any drug. Since nothing was seen with V at this threshold FDA required it to be lowered to 2%. Still nothing seen. So this is when FDA said well you have to list something for fair balance.
Say what? Who told you this? FDA changing rules for AMRN again? Nothing in this doc that mentions exact %'s, just a vague "specified rate":
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075057.pdf The ADVERSE REACTIONS section must include a listing of all such reactions that occurred at or above a specified rate that is appropriate to the drug’s safety database (see III.B.3), a separate listing of those adverse reactions that occurred below the specified rate, but for which there is some basis to believe there is a causal relationship between the drug and the event
The ADVERSE REACTIONS section next should list the adverse reactions identified from clinical trials that occurred at or above a specified rate appropriate to the database (for purposes of this guidance, “common” adverse reactions). The listing must include the rate of occurrence of an adverse reaction for the drug and any comparators (active- or placebo-controls), unless such data cannot be determined or presenting the rates for a comparator would be misleading (§ 201.57(c)(7)(ii)(A)). To permit side-by-side comparison of adverse reaction rates, common adverse reactions are typically presented in a table. 4
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