Question:
Have you ever used Meridia (sibutramine) for loosing weight? I have
read it today and I`m wondering if some if you have some experience
whith this drug? Thanks! :)

Answer:
Hey Kety, how are you doing? This medicine has been shown to be
effective only when Meridia used in conjunction with exercise and
proper diet and nutrition. Make sure before ordering that this is the
right medication for you. From January 7 through January 28, 2002,
and March 21 through April 3, 2002, investigators from the Food and
Drug Administrations (FDA) Chicago District office conducted
inspections of Abbott Laboratories firm located Abbott Park, IL. The
purpose of these inspections was to determine Abbott Laboratoriess
compliance with the postmarketing adverse drug experience reporting
requirements of Section 505(k) of the Federal Food, Drug, and Cosmetic
Act ("the Act") and Title 21, Code of Federal Regulation (CFR), Part
314.80. Based on our review of the inspection reports and reports
submitted by your Abbott Laboratories to FDA, we conclude that Abbott
Laboratories firm failed to comply with Section 505(k)(1) of the Act
and 21 CFR 314.80. Section 505(k)(1) requires an applicant to
establish and maintain records, and report data relating to clinical
experience and other data or information for drugs for which au
approval of an application tied under 505(b) or 505(i) is in effect.
Deviations from the 21 CFR 314.80 included In violation of 21 CFR
314.80(c)(1)(i), Abbott Laboratories did not submit serious and
unexpected adverse drug experience reports in several cases to FDA
within 15 calendar days of initial receipt of the information. For
example, our investigator observed that for the period from January 1,
2000 to October 31, 2001, there were eighteen 15-day alert reports
submitted late to FDA. These violative reports include, but are not
limited to: * Abbott Laboratories incorrectly categorized these
reports as periodic adverse drug experience reports, which are
required to be submitted to FDA at quarterly intervals for three years
after the date of approval of an application. * Because these
adverse events were both serious and unexpected as defined in 21 CPR
314.80(a), Abbott Laboratories were required to submit these reports
to FDA within 15 days, as required by 21 CFR 314.80(c)(1)(i).
Abbott Laboratories have in place to ensure that the Standard
Operating Procedures are fully implemented and reflect the actual
practices used by the firm and its affiliates and contractors for
adverse event reporting is unknown. Best wishes,