Depot medroxyprogesterone acetate (DMPA) is a progestin-only hormonal contraceptive birth control drug which is injected every 3 months. A progestin is a synthetic progestagen that has progestinic effects similar to Progesterone. Hormonal contraception refers to Birth control methods that act on the hormonal system Birth control, sometimes synonymous with contraception, is a regimen of one or more actions devices or Medications followed in order to deliberately prevent

Depot medroxyprogesterone acetate (DMPA) is an aqueous suspension for depot injection of the pregnane 17α-hydroxyprogesterone-derivative progestin medroxyprogesterone acetate. In Chemistry, A suspension is a Heterogenous fluid containing Solid particles that are sufficiently large for Sedimentation. An injection is an infusion method of putting Liquid into the Body, usually with a hollow needle and a Syringe which is pierced through Pregnanes are Steroid derivatives with carbons present at positions 1 through 21 A progestin is a synthetic progestagen that has progestinic effects similar to Progesterone. Medroxyprogesterone is a Progestin, and is commonly a component of Hormonal Contraceptives.

Depo-Provera Contraceptive Injection is the brand name for a 150 mg aqueous suspension of medroxyprogesterone acetate for depot intramuscular injection every 3 months (12–13 weeks) manufactured by Pfizer. Medroxyprogesterone is a Progestin, and is commonly a component of Hormonal Contraceptives. An injection is an infusion method of putting Liquid into the Body, usually with a hollow needle and a Syringe which is pierced through Pfizer Incorporated ( is a major Pharmaceutical company, which ranks number one in the world in sales

depo-subQ provera 104 is the brand name for a 104 mg aqueous suspension of medroxyprogesterone acetate for depot subcutaneous injection every 3 months (12–14 weeks) manufactured by Pfizer. An injection is an infusion method of putting Liquid into the Body, usually with a hollow needle and a Syringe which is pierced through

depo-subQ provera 104 was approved in the United States by the FDA for contraceptive use on December 17, 2004, and for management of endometriosis-related pain on March 25, 2005. The United States of America —commonly referred to as the Endometriosis (from endo, "inside" and metra, " Womb " is a common medical condition characterized by growth beyond or outside the uterus

Mechanism of action

The mechanism of action of progestogen-only contraceptives depends on the progestogen activity and dose. High-dose progestogen-only contraceptives, such as injectable DMPA, inhibit follicular development and prevent ovulation as their primary mechanism of action. The follicular phase (or proliferative phase) is the phase of the Estrous cycle, (or in humans and Great apes the Menstrual cycle) during Note This article deals primarily with Human ovulation nonhuman Animal ovulation is touched on briefly at the conclusion ^[1][2]

The progestogen decreases the pulse frequency of gonadotropin-releasing hormone (GnRH) release by the hypothalamus, which decreases the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) by the anterior pituitary. Gonadotropin-releasing hormone ( GNRH) also known as Luteinizing-hormone releasing hormone ( LHRH) is a tropic Peptide Hormone The hypothalamus links the Nervous system to the Endocrine system via the Pituitary gland (hypophysis Follicle-stimulating hormone ( FSH) is a Hormone synthesized and secreted by Gonadotropes in the Anterior pituitary gland. Luteinizing hormone ( LH, also known as lutropin) is a Hormone produced by the Anterior pituitary gland. The anterior pituitary (also called the adenohypophysis, from Greek adeno, "gland" hypo, "under" physis, "growth" Decreased levels of FSH inhibit follicular development, preventing an increase in estradiol levels. Estradiol (17β-estradiol (also oestradiol) is a Sex hormone. Progestogen negative feedback and the lack of estrogen positive feedback on LH release prevent a LH surge. Negative Feedback feeds part of a System 's output inverted into the system's input generally with the result that fluctuations are attenuated Estrogens (US otherwise oestrogens or œstrogens) are a group of Steroid compounds named for their importance in the Estrous cycle, Positive feedback, sometimes referred to as "cumulative causation" is a Feedback loop system in which the system responds to perturbation in the same direction Inhibition of follicular development and the absence of a LH surge prevent ovulation. ^[3][4]

A secondary mechanism of action of all progestogen-containing contraceptives is inhibition of sperm penetration by changes in the cervical mucus. A spermatozoon or spermatozoan ( pl spermatozoa) from the Ancient Greek σπέρμα (seed and ζῷον (living being and more commonly known The cervix (from Latin "neck" is the lower narrow portion of the Uterus where it joins with the top end of the Vagina. ^[5]

Inhibition of ovarian function during DMPA use causes the endometrium to become thin and atrophic. The endometrium is the inner membrane of the Mammalian Uterus. These changes in the endometrium could, theoretically, prevent implantation. However, because DMPA is highly effective in inhibiting ovulation and sperm penetration, the possibility of fertilization is negligible. Human fertilization is the union of a human egg and sperm, usually occurring in the Ampulla of the fallopian tube. No available data support prevention of implantation as a mechanism of action of DMPA. ^[5]

Effectiveness

The life-table first-year failure rates for 8,183 women using Depo-Provera in seven prospective clinical trials were: 0%, 0%, 0. Decrement tables, also called life table methods, are used to calculate the probability of certain events 1%, 0. 2%, 0. 2%, 0. 3%, and 0. 7%, with a weighted average of 0. 3%. ^[6]

The Pearl Index first-year failure rates for 2,042 women using depo-subQ 104 in three prospective clinical trials were: 0%, 0%, and 0%, with a weighted average of 0%. The Pearl Index, also called the Pearl rate, is the most common technique used in Clinical trials for reporting the effectiveness of a Birth control method ^[7]

The first-year failure rate for 209 women using Depo-Provera in one retrospective survey was: 2. 6%. ^[8][9]

• the 1995 National Survey of Family Growth (NSFG) — a retrospective survey based on a woman's recall, during a 90-minute interview, of her month-by-month contraceptive use during the preceding 4 to 5 years^[8][10]

Perfect use

Trussell's estimated perfect use first-year failure rate for Depo-Provera is the weighted average of failure rates in seven clinical trials: 0. 3%. ^[6][11]

• considered perfect use because the clinical trials measured efficacy during actual use of Depo-Provera
  • defined as being no longer than 14 or 15 weeks after an injection (i. e. , no more than 1 or 2 weeks late for a next injection)

Typical use

Prior to 2004, Trussell's typical use failure rate for Depo-Provera was the same as his perfect use failure rate: 0. 3%. ^[12]

• Depo-Provera estimated typical use first-year failure rate = 0. 3% in:
  • Contraceptive Technology, 16th revised edition (1994)^[13]
  • Contraceptive Technology, 17th revised edition (1998)^[14]
    • adopted in 1998 by the FDA for its current Uniform Contraceptive Labeling guidance^[15]

In 2004, using the 1995 NSFG failure rate, Trussell increased (by 10 times) his typical use failure rate for Depo-Provera from 0. 3% to 3%. ^[6][11]

• Depo-Provera estimated typical use first-year failure rate = 3% in:
  • Contraceptive Technology, 18th revised edition (2004)^[6]
  • Contraceptive Technology, 19th revised edition (2007)^[16]

Trussell did not use 1995 NSFG failure rates as typical use failure rates for the other two then newly available long-acting contraceptives, the Norplant implant (2. Norplant is a form of Birth control developed by the Population Council that was first approved in 1983 in Finland, where it was manufactured 3%) and the ParaGard copper T 380A IUD (3. An intrauterine device ( intra meaning within, and uterine meaning of the Uterus) is a Birth control device placed 7%), which were (as with Depo-Provera) an order of magnitude higher than in clinical trials. Since Norplant and ParaGard allow no scope for user error, their much higher 1995 NSFG failure rates were attributed by Trussell to contraceptive overreporting at the time of a conception leading to a live birth. ^[6][9][11]

Benefits

Depo-Provera has several advantages:^{[3][4][17][18]}

• Highly effective at preventing pregnancy.
• Injected every 12 weeks. The only continuing action is to book subsequent follow-up injections every twelve weeks, and to monitor side effects to ensure that they do not require medical attention.
• No estrogen. Estrogens (US otherwise oestrogens or œstrogens) are a group of Steroid compounds named for their importance in the Estrous cycle, No increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, or myocardial infarction. In Medicine, deep vein thrombosis (also known as deep-vein thrombosis or deep venous thrombosis and usually abbreviated as DVT) is the formation Pulmonary embolism (PE is a blockage of the Pulmonary artery or one of its branches usually occurring when a venous Thrombus (blood clot from a vein A stroke is the rapidly developing loss of brain functions due to a disturbance in the blood vessels supplying blood to the brain Myocardial infarction ( MI or AMI for acute myocardial infarction) also known as a heart attack, occurs when the blood supply
• Culturally acceptable. Some cultures believe injections are especially efficacious. Injections also afford privacy because use is not detectable.
• Minimal drug interactions (compared to other hormonal contraceptives). A drug interaction is a situation in which a substance affects the activity of a drug, i Hormonal contraception refers to Birth control methods that act on the hormonal system
• Decreased risk of endometrial cancer. Endometrial cancer refers to several types of malignancy which arise from the Endometrium, or lining of the Uterus. Depo-Provera reduces the risk of endometrial cancer by 80%. ^[19][20][21] The reduced risk of endometrial cancer in Depo-Provera users is thought to be due to both the direct anti-proliferative effect of progestogen on the endometrium and the indirect reduction of estrogen levels by suppression of ovarian follicular development. ^[22]
• Decreased risk of iron deficiency anemia, pelvic inflammatory disease (PID), ectopic pregnancy, and uterine fibroids. For a discussion of iron deficiency more broadly see the Wikipedia article iron deficiency. Pelvic inflammatory disease (or disorder) ( PID) is a generic term for Inflammation of the female Uterus, Fallopian tubes, and/or An ectopic pregnancy is a Complication of pregnancy in which the fertilized Ovum is implanted in any tissue other than the uterine wall Uterine fibroids (singular Uterine Fibroma) ( leiomyomata, singular leiomyoma) are Benign Tumors which grow from the muscle layers of
• Decreased symptoms of endometriosis. Endometriosis (from endo, "inside" and metra, " Womb " is a common medical condition characterized by growth beyond or outside the uterus
• Decreased incidence of primary dysmenorrhea, ovulation pain, and functional ovarian cysts. Dysmenorrhea (or dysmenorrhoea) is a medical condition characterized by severe Uterine Pain during Menstruation. Mittelschmerz ( German: "middle pain" is a medical term for "ovulation pain" or "midcycle pain" An ovarian cyst is any collection of fluid surrounded by a very thin wall within an Ovary.
• Decreased incidence of seizures in women with epilepsy. An epileptic seizure is caused by excessive and/or hypersynchronous electrical Neuronal activity and is usually self-limiting Epilepsy is a common chronic Neurological disorder that is characterized by recurrent unprovoked seizures. Additionally, unlike most other hormonal contraceptives, Depo-Provera's contraceptive effectiveness is not affected by enzyme-inducing antiepileptic drugs. Enzyme inhibitors are Molecules that bind to Enzymes and decrease their activity. The anticonvulsants, also called antiepileptic drugs (abbreviated "AEDs" are a diverse group of pharmaceuticals used in the treatment of epileptic ^[23]
• Decreased incidence and severity of sickle cell crises in women with sickle-cell disease. Sickle-cell disease or sickle-cell anaemia (or anemia) is a Blood disorder characterized by Red blood cells that assume an abnormal rigid ^[17]

Pregnancy and breastfeeding

Depo-Provera may be used by breast-feeding mothers. Heavy bleeding is possible if given in the immediate postpartum time and is best delayed until six weeks after birth. Postnatal ( Latin for 'after birth' from post meaning "after" and natalis meaning "of birth" is the period beginning immediately after It may be used within five days if not breast feeding. While a study showed "no significant difference in birth weights or incidence of birth defects" and "no significant alternation of immunity to infectious disease caused by breast milk containing DMPA", a subgroup of babies whose mothers started Depo-Provera at 2 days postpartum had a 75% higher incidence of doctor visits for infectious diseases during their first year of life. ^[24]

A larger study with longer follow-up concluded that "use of DMPA during pregnancy or breastfeeding does not adversely affect the long-term growth and development of children". This study also noted that "children with DMPA exposure during pregnancy and lactation had an increased risk of suboptimal growth in height," but that "after adjustment for socioeconomic factors by multiple logistic regression, there was no increased risk of impaired growth among the DMPA-exposed children. " The study also noted that effects of DMPA exposure on puberty require further study, as so few children over the age of 10 were observed. ^[25]

Disadvantages and side effects

Warnings and precautions

• Takes seven days to take effect if given after the first four days of the period cycle. Effective immediately if given during the first four days of the period cycle.
• Offers no protection against Sexually transmitted diseases (STDs). A sexually transmitted disease ( STD) or venereal disease ( VD) is an illness that has a significant probability of transmission between Humans
• Depo-Provera can affect menstrual bleeding. After a year of use, 55% of women experience amenorrhoea; after 2 years, the rate rises to 68%. Amenorrhoea ( BE) amenorrhea ( AmE) or amenorrhœa, is the absence of a Menstrual period in a woman of reproductive age In the first months of use "irregular or unpredictable bleeding or spotting, or rarely, heavy or continuous bleeding" was reported. ^[26]
• Delayed return of fertility. Fertility is the natural capability of giving life As a measure "Fertility Rate" is the number of children born per couple person or population The average return to fertility is 9 to 10 months after the last injection. By 18 months after the last injection, fertility is the same as that in former users of other contraceptive methods^[3][4]
• Long-term studies of users of Depo-Provera have found slight or no increased overall risk of breast cancer. However, the study population did show a slightly increased risk of breast cancer in recent users (Depo use in the last four years) under age 35, similar to that seen with the use of combined oral contraceptive pills. ^[26]
• A study of accidental pregnancies among poor women in Thailand found that infants who had been exposed to Depo-Provera during pregnancy had a higher risk of low birth weight and an 80% greater-than-usual chance of dying in the first year of life. ^[27]

Black box warning

While it has long been known that Depo-Provera causes bone loss, it has recently been discovered that the osteoporotic effects of the injection grow worse the longer Depo-Provera is administered, may remain long after the injections are stopped, and may be irreversible. Osteoporosis is a Disease of Bone that leads to an increased risk of fracture. For this reason, on November 17, 2004 the United States Food and Drug Administration and Pfizer agreed to put a "black box warning" on Depo-Provera's label. Events 284 - Diocletian is proclaimed emperor by his soldiers "MMIV" redirects here For the Modest Mouse album see " Baron von Bullshit Rides Again " In the United States, a black box warning (also sometimes called a black label warning or boxed warning) is a type of warning that appears on the Package ^[28] However, the World Health Organization (WHO) advises that the use of Depo-Provera should not be restricted. ^[29][30]

It is unclear whether the bone density loss associated with Depo-Provera use is reversible, and if so, how completely. Three studies have suggested that bone loss is reversible after the discontinuation of Depo-Provera, although one notes that bone loss was not reversible in long-term users of Depo-Provera. ^[31][32][33] Other studies have suggested that the effect of Depo-Provera use on post-menopausal bone density is minimal,^[34] perhaps because Depo users experience less bone loss at menopause. ^[35] However, as of 2006, no study has directly examined fracture risk in post-menopausal women who have used Depo-Provera; therefore, the risk is unknown. Pfizer and the FDA recommend that Depo-Provera not be used for longer than 2 years, unless there is no viable alternative method of contraception, due to concerns over bone loss. ^[28]

Side effects

In the largest clinical trial of Depo-Provera, the most frequently reported adverse reactions (which may or may not be related to the use of Depo-Provera) were: menstrual irregularities (bleeding or amenorrhea or both), abdominal pain or discomfort, weight changes, headache, asthenia (weakness or fatigue), and nervousness. Amenorrhoea ( BE) amenorrhea ( AmE) or amenorrhœa, is the absence of a Menstrual period in a woman of reproductive age Asthenia ( Greek: ασθένεια, lit lack of strength but also disease) is a medical term denoting symptoms of physical weakness Other, less frequently reported adverse reactions are listed in the patient and physician label information for Depo-Provera. ^[26][36]

Related studies

• A study of 819 women in one city found an association between using Depo-Provera and higher incidence of chlamydia and gonorrhea. Gonorrhea (also gonorrhoea) caused by the bacteria Neisseria gonorrhoeae, is a common Sexually transmitted disease. ^[37] A second prospective study in 948 Kenyan women found that Depo-Provera use was associated with higher rates of chlamydial infection, but lower rates of trichomoniasis and pelvic inflammatory disease, when compared to women using no contraception. Pelvic inflammatory disease (or disorder) ( PID) is a generic term for Inflammation of the female Uterus, Fallopian tubes, and/or ^[38]
• Primate studies of medroxyprogesterone have suggested that it may increase the risk of transmission of simian immunodeficiency virus (SIV), an animal model of HIV. Simian immunodeficiency virus ( SIV) is a Retrovirus that is found in numerous strains in Primates; the specific strains infecting Humans Human immunodeficiency virus ( HIV) is a Lentivirus (a member of the Retrovirus family that can lead to acquired immunodeficiency syndrome ^[39][40] At least one study in humans has suggested an increased rate of HIV infection in Depo-Provera users,^[41] while a number of other studies have found no such association. ^[42][43][44] A large prospective clinical trial addressing the issue of Depo-Provera and HIV susceptibility is currently ongoing. ^[45]

Contraindications

The WHO Medical Eligibility Criteria for Contraceptive Use and RCOG Faculty of Family Planning & Reproductive Health Care (FFPRHC) UK Medical Eligibility Criteria for Contraceptive Use list the following as conditions where use of Depo-Provera is not usually recommended or should not be used because of an unacceptable health risk or because it is not indicated:^[46][47]

Conditions where the theoretical or proven risks usually outweigh the advantages of using Depo-Provera:

• Multiple risk factors for arterial cardiovascular disease
• Current deep vein thrombosis (DVT) or pulmonary embolus (PE)
• Migraine headache with aura while using Depo-Provera
• Before evaluation of unexplained vaginal bleeding suspected of being a serious condition
• Past history of breast cancer and no evidence of current disease for 5 years
• Active liver disease: (acute viral hepatitis, severe decompensated cirrhosis, benign or malignant liver tumours)
• Conditions of concern for hypo-estrogenic effects and reduced HDL levels theoretically increasing cardiovascular risk:
  • Hypertension with vascular disease
  • Current and history of ischemic heart disease
  • History of stroke
  • Diabetes for over 20 years or with nephropathy/retinopathy/neuropathy or vascular disease

Conditions which represent an unacceptable health risk if Depo-Provera is used:

• Current or recent breast cancer (a hormonally sensitive tumour)

Conditions where use of Depo-Provera is not indicated and should not be initiated:

• Pregnancy

Other uses

Depo-Provera is also used with male sex offenders as a form of chemical castration as it has the effect of drastically reducing sex drive in males. The Royal College of Obstetricians and Gynaecologists (RCOG is a professional association based in the UK. Arteries are Blood vessels that carry blood away from the Heart. Cardiovascular disease or cardiovascular diseases refers to the class of diseases that involve the Heart or Blood vessels ( arteries and In Medicine, deep vein thrombosis (also known as deep-vein thrombosis or deep venous thrombosis and usually abbreviated as DVT) is the formation Pulmonary embolism (PE is a blockage of the Pulmonary artery or one of its branches usually occurring when a venous Thrombus (blood clot from a vein Migraine is a neurological Syndrome characterized by altered bodily experiences painful headaches and nausea An aura is the perceptual disturbance experienced by some Migraine sufferers before a migraine headache and the telltale sensation experienced by some people with Epilepsy Vaginal bleeding refers to bleeding in females that is either a physiologic response during the non-conceptional Menstrual cycle or caused by hormonal or organic problems of Breast cancer is a Cancer that starts in the cells of the Breast in women and men Liver disease is a broad term describing any number of Diseases affecting the Liver. Hepatitis (plural hepatitides) implies injury to the Liver characterized by the presence of Inflammatory cells in the tissue of Cirrhosis is a consequence of chronic Liver Disease characterized by replacement of liver tissue by fibrous Scar tissue as well as regenerative Hepatocellular adenoma, also hepatic adenoma, or rarely hepadenoma, is an uncommon benign Liver tumour which is associated with the use of types of Hepatocellular carcinoma (HCC also called hepatoma) is a primary malignancy (cancer of the Liver. Hepatic tumors are tumors or growths on or in the Liver (medical terms pertaining to the Liver often start in hepato- or hepatic from the High-density lipoproteins ( HDL) is one of the 5 major groups of Lipoproteins ( Chylomicrons, VLDL, IDL, LDL, HDL Hypertension, also referred to as high blood pressure, HTN or HPN, is a medical condition in which the Blood pressure is chronically elevated Vascular disease is a form of Cardiovascular disease primarily affecting the Blood vessels. Ischaemic or ischemic heart disease (IHD or myocardial ischaemia, is a Disease characterized by reduced blood supply to the heart muscle A stroke is the rapidly developing loss of brain functions due to a disturbance in the blood vessels supplying blood to the brain Diabetes mellitus (ˌdaɪəˈbiːtiːz or /ˌdaɪəˈbiːtəs/ /məˈlaɪtəs/ or /ˈmɛlətəs/ often referred to simply as diabetes ( Ancient Greek: grc Diabetic nephropathy ( nephropatia diabetica) also known as Kimmelstiel-Wilson syndrome and intercapillary glomerulonephritis, is a progressive Kidney Diabetic retinopathy is Retinopathy (damage to the Retina) caused by complications of Diabetes mellitus, which can eventually lead to Blindness Diabetic neuropathies are neuropathic disorders that are associated with Diabetes mellitus. Vascular disease is a form of Cardiovascular disease primarily affecting the Blood vessels. Breast cancer is a Cancer that starts in the cells of the Breast in women and men Pregnancy ( Latin graviditas) is the carrying of one or more offspring known as a Fetus or Embryo, inside the Uterus of a Female Chemical castration is a form of Castration caused by hormonal Medication. [1]

Controversy over Approval of Depo-Provera in the United States

There was a long, controversial history regarding the approval of Depo-Provera by the U. S. Food and Drug Administration. The original manufacturer, Upjohn, applied repeatedly for approval. The Upjohn Company was a pharmaceutical manufacturing firm founded in 1886 in Kalamazoo Michigan by Dr FDA advisory committees unanimously recommended approval in 1973, 1975 and 1992, as did the FDA's professional medical staff, but the FDA repeatedly denied approval. Ultimately, on October 29, 1992, the FDA approved Depo-Provera, which had by then been used by over 30 million women since 1969 and was approved and being used by nearly 9 million women in more than 90 countries, including the United Kingdom, France, Germany, Sweden, Thailand, New Zealand and Indonesia. Events 437 - Valentinian III, Western Roman Emperor, marries Licinia Eudoxia, daughter of his cousin Theodosius II Year 1992 ( MCMXCII) was a Leap year starting on Wednesday (link will display full 1992 Gregorian calendar) The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom, the UK or Britain,is a Sovereign state located This article is about the country For a topic outline on this subject see List of basic France topics. Germany, officially the Federal Republic of Germany ( ˈbʊndəsʁepuˌbliːk ˈdɔʏtʃlant is a Country in Central Europe. "Sverige" redirects here For other uses see Sweden (disambiguation and Sverige (disambiguation. The Kingdom of Thailand (ˈtaɪlænd ราชอาณาจักรไทย, râːtɕʰa-ʔaːnaːtɕɑ̀k-tʰɑj New Zealand is an Island country in the south-western Pacific Ocean comprising two main landmasses (the North Island and the South Island The Republic of Indonesia ( (Republik Indonesia is a Country in Southeast Asia. ^[48] Points in the controversy included:

• Animal testing for carcinogenicity. The term carcinogen refers to any substance Radionuclide or radiation that is an agent directly involved in the promotion of Cancer or in the fatation of its propagation Depo-Provera caused breast cancer tumors in dogs. Critics of the study claimed that dogs are more sensitive to artificial progesterone, and that the doses were too high to extrapolate to humans. The FDA pointed out that all substances carcinogenic to humans are carcinogenic to animals as well, and that if a substance is not carcinogenic it does not register as a carcinogen at high doses. Levels of Depo-Provera which caused malignant mammary tumors in dogs were equivalent to 25 times the amount of the normal luteal phase progesterone level for dogs. The luteal phase (or secretory phase) is the latter phase of the Menstrual cycle (in humans and a few other animals or the Estrous cycle (in other (Which is lower than the pregnancy level of progesterone for dogs, and is species-specific. )[2]
  Depo-Provera caused endometrial cancer in monkeys—2 of 12 monkeys tested, the first ever recorded cases of endometrial cancer in rhesus monkeys. The Rhesus Macaque ( Macaca mulatta) often called the Rhesus Monkey, is one of the best known species of Old World monkeys Adult males measure ^[49] However, subsequent studies have shown that in humans, Depo-Provera actually reduces the risk of endometrial cancer by approximately 80%. ^[19][20][21]
  Speaking in comparative terms regarding animal studies of carcinogenicity for drugs, a member of the FDA's Bureau of Drugs testified at an agency Depo hearing, ". . . Animal data for this drug is more worrisome than any other drug we know of that is to be given to well people. "
• Cervical cancer in Upjohn/NCI studies. Cervical cancer was found to be increased as high as 9-fold in the first human studies recorded by the manufacturer and the National Cancer Institute. The National Cancer Institute (NCI is part of the United States Federal government's National Institutes of Health. ^[50] However, numerous larger subsequent studies have shown that Depo-Provera use does not increase the risk of cervical cancer. ^{[51][52][53][54][55]}
• Coercion and lack of informed consent. Testing/use of Depo was focused almost exclusively on women in developing countries and poor women of color in the US,^[56] raising serious questions about coercion and lack of informed consent, particularly for the illiterate^[57] and for the mentally challenged, who in some reported cases were given Depo long-term for reasons of "menstrual hygiene", in spite of the fact that they were not sexually active. Developing countries are countries that haven't reached Western-style standards of democratic government free market economy industrialization social programs and human rights guaranties ^[58]
• Atlanta/Grady Study. Upjohn studied the effect of Depo for 11 years in Atlanta, mostly on black women who were receiving public assistance, but did not file any of the required follow-up reports with the FDA. Investigators who eventually visited noted that the studies were disorganized. "They found that data collection was questionable, consent forms and protocol were absent; that those women whose consent had been obtained at all were not told of possible side effects. Women whose known medical conditions indicated that use of Depo would endanger their health were given the shot. Several of the women in the study died; some of cancer, but some for other reasons, such as suicide due to depression. Over half the 13,000 women in the study were lost to followup due to sloppy record keeping. " Consequently, no data from this study was usable. ^[56]
• WHO Review. In 1992, the WHO presented a review of Depo in four developing countries to the FDA. The National Women's Health Network and other women's organizations testified at the hearing that the WHO was not objective, as the WHO had already distributed Depo-Provera in developing countries. The National Women's Health Network (NWHN is a non-profit Women's health advocacy organization located in Washington D Depo was approved for use in US on the basis of the WHO review of previously submitted evidence from countries such as Thailand, evidence which the FDA had deemed insufficient and too poorly designed for assessment of cancer risk at a prior hearing. [3]The Alan Guttmacher Institute has speculated that US approval of Depo may increase its availability and acceptability in developing countries. [4]^[59]

Aftermath

• In 1995, several women's health groups asked the FDA to put a moratorium on Depo-Provera, and to institute standardized informed consent forms. ^[60]
• In 1994, when Depo was approved in India, India's Economic and Political Weekly reported that "The FDA finally licensed the drug in 1990 in response to concerns about the population explosion in the third world and the reluctance of third world governments to license a drug not licensed in its originating country. " ^[61] Some scientists and women's groups in India continue to oppose Depo-Provera. ^[62] In 2002, Depo was removed from the family planning protocol in India.
• One in five black teenagers using birth control in the US uses Depo-Provera, a far higher rate of use than for white teenagers. Activists claim this is because black teenagers are disproportionately targeted for the least safe contraceptives. ^[63]
• The Canadian Coalition on Depo-Provera, a coalition of women's health professional and advocacy groups, opposed the approval of Depo in Canada. ^[64] Since the approval of Depo in Canada in 1997, a $700 million class-action lawsuit has been filed against Pfizer by users of Depo who developed osteoporosis. In Law, a class action or a representative action is a form of Lawsuit where a large group of people collectively bring a claim to court Osteoporosis is a Disease of Bone that leads to an increased risk of fracture. In response, Pfizer argued that it had met its obligation to disclose and discuss the risks of Depo-Provera with the Canadian medical community. ^[65]

Media

• In the episode "Sex Kills" of House, M.D., a clinic patient ask for a prescription of depo-provera for his love of cows. Sex Kills is the fourteenth episode of the second season of House, which premiered on the FOX network on March 7, 2006. House, also known as House MD, is an American Medical drama, which debuted on the FOX network on November 16 2004 A clinic (or an outpatient clinic) is a small private or public health facility that is devoted to the care of Outpatients, often in a community in contrast House is reluctant to prescribe it because of the side effects and doesn't believe the patient's motive. The patient later admits he needs it for his attractive stepmother.

Footnotes

External links

• Pfizer official site
• Research on Injectable contraceptives - Family Health International's fact sheet on injectables, including Depo-Provera.