Amarin Corp Plc (AMRN)

[rafunrafun]

Below is the answer I received from someone in the business regarding my question of why joint pain is listed as a possible side effect... additionally, in my case it's total opposite, my joint pain disappeared in 3 days after taking 4gm of V per day...

" The joint pain listed as Vascepa 's only side effect was 1.3% greater than placebo. Since approx. 25% of patients were on stable statin therapy(MARINE) it is assumed this is the reason joint pain was seen. However, all SE's and AE's of both MARINE & ANCHOR are listed in PI so considering ALL patients were on statin therapy in ANCHOR & ANY statin was allowed and varying doses it's possible V arm had patients with higher statin doses causing more arthralgia.

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.

Hypothetically speaking, if you had a product with multiple SE's and listed with these other SE's was the 1.3% arthralgia most doctors and patients wouldn't think twice but because it's Vascepa 's ONLY LISTED SE it stands out like a sore thumb."