Prescribing Information For Depo-Provera

Published: Fri 19 Nov 2004 05:42 PM
19th November
Pfizer New Zealand Statement Regarding Additional Prescribing Information For Depo-Provera
Pfizer New Zealand has submitted information to Medsafe regarding the potential for bone mineral density changes in women and adolescents taking DEPO PROVERA, a long acting injectable contraceptive, and is awaiting their decision regarding additional warning statements, Pfizer New Zealand General Manager Mark Crotty said today.
Pfizer Inc released the following statement yesterday concerning additional prescribing information for DEPO-PROVERA:
“Pfizer has worked closely with the U.S Food and Drug Administration and has begun alerting healthcare professionals and patients about revised labelling for DEPO-PROVERA regarding the potential for bone mineral density changes in women and adolescents.”
“The primary change in the US Prescribing Information is the addition of more prominent wording in a boxed warning noting that women who use DEPO–PROVERA may lose significant bone density. The revised food labelling further notes that bone loss is greater with increasing duration of use and may not be completely reversible and that DEPO–PROVERA should be used as a long-term birth control method (e.g. longer than 2 years) only if other birth control methods are inadequate.”
Following Medsafe’s decision Pfizer NZ will be writing to all healthcare professionals concerned.
The current New Zealand prescribing information already contains a warning that use of the product may be considered among the risk factors for the development of osteoporosis. Additional clinical research was initiated to clarify the effects of DEPO–PROVERA on bone mineral density in women aged 25-35 and adolescents. The results of theses studies were recently submitted to the FDA and are reflected in the revised labelling for DEPO–PROVERA in the US.
Pfizer Inc has noted that its studies indicated that a decrease in bone mineral density appears to be at least partially reversible in both adults and adolescents when the use of DEPO–PROVERA is discontinued. A study to assess the reversibility of loss of bone mineral density in adolescents is ongoing.

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