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November 21, 2004

Pfizer Statement Regarding Additional Prescribing Information for Depo-Provera

Topics: Clinical Pharmacology

Pfizer Inc issued the following statement on Nov. 18 concerning additional prescribing information for DEPO-PROVERA® (medroxyprogesterone acetate injectable suspension), a long-acting injectable contraceptive:

Pfizer has worked closely with the U.S. Food and Drug Administration and has begun alerting healthcare professionals and patients about revised labeling for DEPO-PROVERA regarding the potential for bone mineral density changes in women and adolescents.

The primary change is the addition of more prominent wording in a boxed warning noting that women who use DEPO-PROVERA may lose significant bone mineral density. The revised labeling 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 two years) only if other birth control methods are "inadequate."

Pfizer is issuing a 'Dear Healthcare Professional' letter as part of an extensive outreach program to healthcare and health professional organizations and women's health advocacy groups. Pfizer is advising women to discuss with their healthcare providers the risks and benefits of initiating or continuing use of DEPO-PROVERA for longer than two years.

Since the U.S. approval of DEPO-PROVERA in 1992, the prescribing information has included a warning that use of the product may be considered among the risk factors for development of osteoporosis. Additional clinical research was initiated in the 1990s to clarify the effects of DEPO-PROVERA on bone mineral density in women aged 25 to 35 and in adolescents. The results of these studies were recently submitted to the FDA and are reflected in the revised labeling for DEPO-PROVERA.

Pfizer noted that its studies indicate 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.

Pfizer claims that DEPO-PROVERA is an important and highly effective contraceptive option for women and that it is one of the most reliable methods of long-acting and reversible contraception available today. Source.

However, in Sex Transm Dis. 2004 Sep;31(9):561-7.
In addition to bone mineral density changes, DMPA use has been shown to appear to be significantly associated with increased acquisition of cervical chlamydial and gonococcal infections...Source...

Update: Still not much in the MSM about this but there are a couple of other blogs that have written of this issue.  Majikthise has a link to a Globe and Mail article. and bioethics.net has also written on the DMPA problem.

Posted by Hyscience at November 21, 2004 7:44 PM



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