The pair will receive an abbreviated public overview, on a single slide -- beginning at 8:15 AM EST on December 8, 2009 -- as FDA staff believes these drugs are not widely prescribed in pediatric settings. To be clear, the full science, safety and efficacy reviews have been/will be undertaken by the committee -- but the public presentation portion will be condensed, according to the FDA staff's cover letter, sent with the relevant background materials. [Click image at right to view full-size.]
In any event, here -- I think -- is the section of the pediatric Vytorin label copy under review, for potential changes:
. . . .From the start of the trial to the end of Week 33, discontinuations due to an adverse reaction occurred in 7 (6%) patients in the ezetimibe coadministered with simvastatin group and in 2 (2%) patients in the simvastatin monotherapy group.
During the trial, hepatic transaminase elevations (two consecutive measurements for ALT and/or AST >3 X ULN) occurred in four (3%) individuals in the ezetimibe coadministered with simvastatin group and in two (2%) individuals in the simvastatin monotherapy group. Elevations of CPK (>10 X ULN) occurred in two (2%) individuals in the ezetimibe coadministered with simvastatin group and in zero individuals in the simvastatin monotherapy group.In this limited controlled study, there was no significant effect on growth or sexual maturation in the adolescent boys or girls, or on menstrual cycle length in girls.
Coadministration of ezetimibe with simvastatin at doses greater than 40 mg/day has not been studied in adolescents. Also, VYTORIN has not been studied in patients younger than 10 years of age or in premenarchal girls. . . .
I'll be on a plane Tuesday morning, so watch the wires for news. I'll post -- if something unusual transpires -- later in the day Tuesday.
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