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Depo-Medroxyprogesterone Acetate Clinical Update
Scott J Spear, MDMedical DirectorPlanned Parenthood of the Texas Capital Region &Planned Parenthood of Central TexasClinical Assistant Professor of Obstetrics & GynecologyUT Southwestern Medical Center
Learning Objectives
• Provide background and description of DMPA• List mechanism of action, efficacy,
advantages, and disadvantages of DMPA• Describe examples of good candidates for
DMPA use• Discuss DPMA Black Box Warning • Discuss research on DMPA and it’s impact on
BMD and skeletal healthmore…
Learning Objectives (continued)
• Critically examine recommendation for “add-back” estrogen or DEXA scans for minors
• Present ACOG’s and WHO’s Guidance on DMPA
DMPA: Background
• Since introduction in 1963, used safely in >30 million women worldwide
• >2 million US women currently use DMPA
• Temporary bone loss
ACOG Committee Opinion No. 415. Obstet Gynecol. 2008.
• Depot Medroxyprogesterone Acetate (DMPA)
• Brand names: Depo-Provera® and Depo-subQ provera 104™
• Intramuscular or subcu-taneous injection every 3 months
Goldberg AB. Contraceptive Technology. 2007;
Description of DMPA
Mechanism of Action: DMPA
PreventsOvulation
Reduces production of
estradiol
Goldberg AB. Contraceptive Technology. 2007.
Candidates for DMPA
• Women who want reversible, non-daily contraception▪ The percentage of teens who use DMPA increased
from 10% in 1995 to 21% in 2002
• Women in whom estrogen is contraindicated• Women who experience menorrhagia,
dysmenorrhea, and iron deficiency anemia• Women who don’t wish to conceive
immediately after discontinuing this method
Cromer BA. Am J Obstet Gynecol. 2005.; Westhoff C. Contraception. 2003.; Trussell J. Contraceptive Technology. 2007.
DMPA: Failure Rate
Perfect Use
0.3%
Typical Use
3%
Westhoff C. Contraception. 2003.; Cromer BA. Am J Obstet Gynecol. 2005.
Risks and Side Effects of DMPA
Nelson AL. J Reprod Med. 1996.; Kaunitz AM, Contraception. 2008.
Weight Gain
Menstrual cycle
changes
BMD Loss
Advantages of DMPAConvenient, discrete, very effective, reversible
May improve menorrhagia, dysmenorrhea, iron deficiency anemia, and endometriosis
Women with contraindications to estrogen can use it
Reduces the risk of endometrial cancer
Reduces risk of PID and uterine leiomyomata
Can decrease the number and severity of crises in patients who have sickle cell anemia
Can decrease frequency of seizures
Thomas DB. Contraception. 1995.; Gray PH. Br J Obstet Gynecol. 1996.; Lumbiganon P J Reprod Med. 1996; Culling VE. J Reprod Med. 1996.; Mattson RH Neurology. 1984.
Disadvantages of DMPA
Requires visit to clinician
Initial irregular bleeding
Weight gain
Short-term, reversible BMD loss
Delayed return to fertility
Lack of protection against STIs
Westhoff C. Contraception. 2003.; Risser WL. Adolesc Health. 2003. Le YL. Obstet Gynecol. 2009.; Kaunitz AM, Contraception. 2008.
Contraindications
• History of or current breast cancer• Anorexia nervosa• Chronic steroid use
WHO. 2004
DPMA Black Box Warning
“It is unknown if use of DMPA Contraceptive Injections during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic
fracture in later life.
FDA Safety Alert. 2009.; Liang BA J Clin Anesth. 2002.
DPMA Black Box Warning
Prolonged use may result in significant loss of bone density
Loss may not be completely reversible
Degree of loss is proportional to the amount of time on DMPA
FDA Safety Alert. 2009
more…
DPMA Black Box Warning (continued)
Woman should use Depo-Provera for more than two years only if other contraceptive methods are inadequate
FDA Safety Alert. 2009
What the Best Science Indicates
• BMD loss associated with DMPA is similar to that associated with pregnancy and breastfeeding
• BMD loss is substantially reversed after stopping use of DMPA
• Environmental factors, such as nutrition and exercise, have a more substantial impact on bone mass than DMPA
Kaunitz AM. Contraception. 2008.
What we know about DMPA and it’s impact on BMD and skeletal health
DMPA users are likely to have a reduced BMD
Suppressed estradiol production is associated with an increased rate of bone resorption
Short-term diminishment of BMD recovers within three years once DMPA is discontinued
DMPA use not linked to the development of menopausal osteoporotic fractures
Cundy T. BMJ. 1991.; Kaunitz AM. Obstet Gynecol Clin North Am. 2000.; Kaunitz AM. Contraception. 2008.; Banks E. BJOG. 2001.; Westhoff CL. Contraception. 2003.; et al.
More Research on DMPA and It’s Impact on BMD
• Former users of DMPA had BMD similar to nonusers
• Adolescents demonstrated a full recovery of BMD within one year after discontinuation of DMPA
Pettiti DB. Obstet Gynecol. 2000.; Scholes D. Arch Pediatr Adolesc Med. 2005.
“Add-back” Estrogen or DEXA scans for Minors
Research indicates
• Estradiol levels mediate BMD changes in adult and adolescent DMPA users
• “Add-back” estrogen prevents the transient decline in the BMD of current DMPA users
• BMD recovers after DMPA is discontinued
• Unlikely that women would benefit from estrogen supplementation or serial surveillance by DEXA scans
more…Cundy T. J Clin Endocrinol Metab. 2003.; Kaunitz AM. Contraception. 1999.
“Add-back” Estrogen or DEXA scans for Minors (continued)
• In adolescents, daily intake of 1500 mg of calcium and 400 mg of vitamin D is recommended
Guidance on DMPA Usage and Skeletal Health
Position statements have been issued by several professional organizations—ACOG & WHO
These organizations recommend no routine BMD testing for DMPA users
These organizations recommend no restrictions on initiation or continuation of DMPA to address skeletal health concerns
Kaunitz AM. Contraception. 2008.
DMPA: ACOG Guidelines
“Concerns regarding the effect of DMPA on BMD should neither prevent practitioners from
prescribing DMPA nor limit its use to 2 consecutive years.”
No need to perform BMD monitoring solely in response to DMPA use.
ACOG Committee Opinion No. 415. Obstet Gynecol. 2008; AAP Policy Statement.Pediatrics. 2007.
more…
DMPA: ACOG Guidelines (continued)
ACOG recommends:• Counsel thoroughly about benefits and risks
of DMPA• Encourage daily exercise and age-
appropriate calcium and vitamin D intake• Estrogen supplementation during DMPA use
is not currently recommended
ACOG Committee Opinion No. 415. Obstet Gynecol. 2008; AAP Policy Statement.Pediatrics. 2007.
DMPA: WHO Guidelines
D’Arcangues C. Contraception. 2006.
• No restriction on DMPA in eligible women 18-45 yrs of age
• Among adolescents and women >45 yrs of age, advantages of DMPA generally outweigh theoretical safety concerns re: fracture risk
• No restrictions on progestin-only or combined hormonal contraception in eligible women
Counseling Messages for DMPA
• Women for whom estrogen products are contraindicated can use DMPA
• Bleeding profile improves over time
• Non-hormonal backup contraception is needed for first 7 days
What Providers Need to Know
• No mandate for serial BMD testing or “add-back” estrogen supplementation
• No need to discontinue DPMA after two years of use
• Supplemental use of menopausal doses of estrogen can be considered for women with additional risk factors for low BMD
• Women should consume appropriate amounts of calcium and vitamin D. more…
FDA Safety Alert. 2009
What Providers Need to Know (continued)
• Concerns about temporary bone loss should be weighed against DMPA’s convenience and efficacy
• Patients should engage in weight-bearing exercise to promote bone health
• Risks associated with DMPA along with genetic and lifestyle factors should be examined
DiVasta AD. Adolesc Med. 2006.
The DMPA picture is generally rosy: