Risk Management Plan (RMP) Survey for Purchasers of Alli® (60 mg Orlistat) in the European Union.
Status:
Withdrawn
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
Following results from the first survey that forms part of the EU RMP for Alli® (RMP survey
1; WEUSRTP3350), several amendments to the information included on the pack carton for Alli®
(orlistat 60 mg) were recommended. The main finding from RMP survey 1 was that a large
proportion of Alli® users had a body mass index (BMI) less than (<)28 kg/m2 . (Note: the
European indication for Alli® is adults 18 years and older with a BMI<28 kg/m2.) The
proportion of respondents overall who reported possible contraindications to Alli® use was
relatively low. The following changes to the pack labeling were agreed and have been
implemented: : (1) a statement, highlighting the product is only for those with a BMI of 28
or above was added to the front of the pack; (2) wording of the BMI statement on the back of
the pack was strengthened; (3) contraindications were highlighted in bold text; (4) the
statement that Alli® is not for use by those under 18 years of age was modified for clarity.
In addition, a pharmacy reminder card was made available to retail pharmacists to improve
awareness of the prescribing information for Alli®. The survey will assess whether compliance
with the authorized indication and contraindications among purchasers of Alli® has been
improved after one year of marketing the revised pack labeling.