Depo-Provera: A Review of the Potential Medical Consequences and Side Effects.

The following is an editorial article written by Millennium Health Centre’s partner Valerie Franc N.D. It appeared in the Ontario Association of Naturopathic Doctors’ professional newsletter for other members in 2004. Readers are encouraged to pay particular attention to the websites mentioned near the end of this editorial for more information on the medical impacts of Depo-Provera, the current legal action and the options women have in treating the potential consequences of this medication. While not everyone will experience these mentioned side effects, its Millennium Health Centre’s desire to provide the public with factual information about Depo-Provera, so that individual women may make fully informed decisions about the use of Depo-Provera.

When I first met Diane she was a bright, ambitious, gregarious woman. She was the kind of woman who constantly looked for a challenge, and could effortlessly organize pure chaos in a matter of minutes. So you can imagine my surprise when she walked into my office only a year later, close to tears and having great difficulty focusing on one train of thought. What could possibly have happened to cause such a remarkable change in her affect and personality?

Nausea, nightmares and insomnia, extreme mood swings, hot flashes, loss of memory, loss of libido, migraines, severe dysmenorrhea, blurred vision, body aches and constant vaginal bleeding were just some of the symptoms which this woman in her mid twenties had been experiencing since being injected with Depo-Provera, and she’s not alone. Although Diane’s symptoms began immediately after her first injection with Depo, she did not connect the two for a number of months. Furthermore upon informing her medical doctor of these symptoms, she was repeatedly reassured that they would disappear after the next injection. When it came time for her next dosage in November of 2003 (approximately one year after the initial injection) Diane refused.

Approximately one month later, and with no change in her symptoms Diane decided to pursue naturopathic therapies. Initially the main focus of treatment was stopping the severe vaginal bleeding and treat the resulting anemia which had occurred. Assuming elevated progesterone levels to be the major source of the bleeding, estrogenic along with astringent herbs were utilized. However these treatments did little to alleviate the symptoms. Upon learning that a common side effect of Depo is suppression of progesterone production, herbs to support this function were introduced. Along with a specific homeopathic remedy and some support for liver function, this approach was successful and we were able to rapidly stop the bleeding.

Tina had a very similar, albeit more intense experience. Tina received her first injection from her OBGyn 6 weeks after giving birth to her first child. Despite the fact that she was breast-feeding at the time, she was told this would be a safe method of contraception for herself, and there would be no effect on her new born daughter. Immediately Tina became severely depressed and experienced daily vaginal bleeding, migraines, nausea, debilitating fatigue, severe pain and blurred vision. Despite having all of the classic adverse reactions she, like Diane (and reportedly many other women who have posted their stories on her website), was told that having just one more injection would alleviate her symptoms. After 18 months of injections and no abatement, she finally decided to discontinue the treatments against the advise of her OBGyn.

Depo-Provera (an injectable contraceptive which is administered every 3 months) was approved for use in Canada only 6 years ago, yet according to IMS Health (a company which tracks prescription drug use) it is one of the top 5 most commonly prescribed drugs for Canadian women aged 17 to 23. Furthermore between 1999 and 2003, in Canada alone, it’s sales have more than doubled from a mere $11.2 million to $24.1 million per year. What is disturbing however is the growing number of reports of serious adverse reactions among its users. Between January 1, 2003 and November 30 2003 Health Canada received more than 200 reports of severe reactions. Similarly the FDA’s Adverse Effects Report from 1997 to 2001 documented more than 4,000 multiple adverse effects from the hormone contained in Depo-Provera. Despite these facts medical doctors continue to prescribe it, as it can be used in cases where estrogen is contra-indicated (e.g. bleeding disorders, family or personal history of breast cancer etc.) and because of convenience.

Currently many Canadian women are considering a class action lawsuit against Pfizer (the company who currently holds the patent, the original maker was Upjohn C0.). Over 10,000 women from Canada and the US have posted their stories on the internet, and 3 lawsuits have been launched in the United States alone. In a recent interview with the Montreal Gazette Dr. Shree Mulhay (epidemiologist and director of the McGill Centre for Research and Teaching on Women) stated that the “ growing popularity among young women who have not started families is disturbing. Long-term use may have an impact on fertility or after effect health problems prevalent after menopause such as osteoporosis and ovarian and uterine cancers”. Furthermore in an interview with Veronique Mandal (Canwest news service) Wayne Saray, Pfizer’s manager of corporate communications stated that “women should be told it can take months, even years, before they can conceive after taking Depo-Provera”.

According to the Womanly Times Archives (an online newsletter provided by the Women’s Health Clinic) as early as 1981, at the 2nd International Conference on Women’s Health in Geneva, health care workers and activists from Canada, India, Bangladesh, Thailand and Latin America voiced concerns. The WHC has been involved in lobbying against this medication for medical as well as human rights issues, stating “serious questions were raised about it’s use in settings such as refugee camps, where women had no choice but to receive ‘the shot’, often with no explanation… Many women’s health and community agencies, including WHC, international development organizations and others have monitored this issue for almost two decades and opposed formal approval of Depo-Provera…” Even Dr. C. Sathyamala, who was involved in the clinical trials in India, is against the utilization of Depo-Provera as a method of contraception. In her review of clinical findings entitled “An Epidemiological Review Of The Injectable Contraceptive, Depo-Provera” she concludes:

“… the published literature on the safety aspects of this drug is scanty and does not reflect 40 years of research. The available studies suffer from inappropriate comparison groups, inadequate sample size, lack of appropriate comparison groups, and high drop out rates or loss of follow up. Results are selectively presented and the conclusions are often reached after inadequate analysis without controlling for confounding variables. The studies carried out by renowned research bodies are also not exempt from several of these short comings… the picture that emerges from the review is that in both women and her progeny, Depo-Provera causes serious adverse drug reactions which could lead to life-threatening complications or life-long disabilities… return of fertility is delayed and… it may lead to permanent infertility due to irreversible atrophy and fibrosis of the ovaries…Depo-Provera appears to be hazardous to the health of the woman and her progeny. The contraceptive appears not to be suitable for nulliparous women, adolescents, breast-feeding women, women who have not completed their family, and women who are in the reproductive age group. In short, there does not seem to be a single group of women for whom Depo-Provera can be safely recommended as a contraceptive method of choice.”

If Tina’s health concerns ended 3 months after her last injection, or if the effects of Depo-Provera only affected herself, she would have returned quite happily to her former life. It didn’t, and even though she has not had an injection for over a year, she is still experiencing side effects severe enough to prevent her from returning to her former occupation as a child care worker. Although the adverse reactions still prevent her from caring for her child at times, the worst reaction has occurred in her daughter. After 9 months of breast-feeding her daughter developed lumps in both breasts. Upon consulting her pediatrician Tina was advised that the lumps were due to the hormones and was advised to wean her off the breast milk immediately. After 3 weeks the lumps were gone, however since that time her daughter has experienced sleep disturbances. While these conditions have not been proven to be associated with it’s consumption, they are commonly reported among children who were breast fed while their mothers were taking Depo-Provera. The effects on puberty, future fertility and the development of hormonally related cancers in children breast fed with Depo-Provera contaminated milk at this time remain unclear. Furthermore, Tina’s chances of conceiving again have been significantly impacted, as according to medical testing her left ovary has been dysfunctional since this time.

In April 2003, Tina launched her own website to provide emotional support for other women in the same circumstances. Together Diane and Tina have met with several journalists, politicians and Anne Rochon Ford of Women’s Protection and Health Canada in Toronto (who lobbied against Depo-Provera 20 years ago). Their hope is to bring public awareness to this issue. “The booklet doesn’t give the negative side-effects and medical doctors don’t know. I lost 3 years of my life because of it. There are still days when I am too ill to play with my child” says Tina. When asked what advice she would give to other women considering this medication as a birth control option, Diane responded:

“In a ‘Perfect World’ every woman on Depo-Provera would have the ability to reverse the so called ‘rare and adverse side effects’, that have instead manipulated and debilitated their daily lives, relationships, emotions, and physical well being. In a ‘Perfect World’ women would be completely informed of the ramifications that this ‘safe and convenient’ injection causes. We do not live in a ‘Perfect World’. Women had no option but to be blinded. Their physicians and the pharmaceutical company had the option and TURNED A BLIND EYE. I am one of these women, whose life has been severely affected. I am no longer the same woman I was a year ago. I want that woman back... I cannot go back...”

For some women Depo-Provera may be a safe and effective method of birth control. However there are many potential side effects, which may seriously impact on the present and future health of both women and their children. Anyone considering Depo-Provera should be adequately screened and informed of the potential side effects. Women who choose this form of contraception should consult their health care practitioner at the first sign of any adverse reaction.

For More Information, please review the following. The websites (numbers 2 and 3) can be linked from the Millennium Health Centre’s ‘Links’ main page. Number 1 is the email of a chat room and is an excellent read. You can find several other important chat rooms on the subject by typing in ‘groups and depo-provera’ on your search engine.

1. depoproverausers@sympatico.ca

2. http://www.womenshealthclinic.org

3. http://www.greatreporter.com

4. An Epidemiological Review of the Injectable Contraceptive, Depo-Provera - Dr. C. Sathyamala

Adverse Reactions Of Depo-Provera

Severe depression

Muscle weakness

Diabetes

Increased transmission of HIV

Weight gain

Prolonged vaginal bleeding

Sleep disorders

Breathing difficulties

Slurred speech

Pulmonary embolism

Hypertension & Hyperlipidemia

Confusion

Decreased or loss of libido

Convulsions

Cervical erosion,

Cholestatic jaundice

Alopecia

Climacteric like syndrome (vaginal dryness, hot flashes etc.)

Sudden or partial loss of vision

Increased androgens & acne

Weight gain

Amenorrhea (loss of period)

Heart palpitations

Pregnancy

Breast and / or cervical cancer. Multiple fractures

Breast tenderness

Hirsutism (body hair growth)

Mutagenic and teratogenic effects (mutations of offspring)

Infertility or delayed return of fertility

Dr. Stephen F. Jones B.comm, N.D.

Doctor of Naturopathic Medicine

Editor – The Health Journal

Clinic Director – The Millennium Health Centre