Friday, November 18, 2011 1:19:12 PM
Black Box Warning Label: VISION LOSS
Sabril causes progressive and permanent bilateral concentric visual field constriction in a
high percentage of patients. In some cases, Sabril may also reduce visual acuity.
Risk increases with total dose and duration of use, but no exposure to Sabril is known that
is free of risk of vision loss.
Risk of new and worsening vision loss continues as long as Sabril is used, and possibly
after discontinuing Sabril.
Periodic vision testing is required for patients on Sabril, but cannot reliably prevent vision
damage.
Because of the risk of permanent vision loss, Sabril is available only through a special
restricted distribution program.
btw, pre-clinical, CPP115 has shown greater efficacy and a far better safety profile at lower doses. I'm highly anticipating the P1 data due Q1/2 next year. If the data proves out, I would think at the very least Lundbeck would want to protect its investment in Sabril.
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