Hormonal Contraceptives

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Introduction

Here are two recent evidence-based reviews of the potential dangers of hormonal contraceptives:

  • Citizens' Petition on Hormonal Contraceptives June 2019
  • BMJ Rapid Response on 'Oestrogen-containing contraceptive pills' study of August 2016

Citizens' Petition on Hormonal Contraceptives June 2016

A Citizens' Petition was compiled and recently [June 2019] filed with the FDA (Food and Drug Administration) requesting more transparency and patient warnings regarding potential side effects for different forms of hormonal contraceptives.

You can read the full document here:

Citizens' Petition on Hormonal Contraceptives June 2016

This document is 98 pages long and references dozens of studies.

In its Preliminary Statement it states that:

Hormonal contraceptives have been on the market for over 50 years and, while their formulations have changed, the basic mechanism of action has remained the same. During this time numerous studies have been performed documenting side effects, some of which appear over time, some within weeks or months, but all can have a serious impact on health. An effort was made to perform a series of comprehensive literature surveys to better understand immediate and long-term side effects of these agents. The results of this literature review have led to several recommendations. These recommendations are listed below with the documentation of the research noted on the following pages.

And here are the recommendations made in this Petition:

Drugs which should be removed from the market:

  • Depot Medroxyprogesterone Acetate (DMPA)

Recommendation to remove from the market the injectable contraceptive Depot Medroxyprogesterone Acetate (DMPA; Depo Provera) based on conclusive evidence that it facilitates the transmission of HIV from men to women. Numerous alternatives are available.

Black box warnings that should be added to prescribing information:

  • Breast Cancer

Combined estrogen-progestogen contraceptives (COCs, including oral, intravaginal and transdermal formulations) are acknowledged by IARC as Group I carcinogens. Substantial data supports an increased risk of breast cancer with the use of COCs. A black box warning should be added to the labeling of all COCs that they have been shown to increase the risk of breast cancer. Patient-related materials should also adequately convey this risk. Progestogen-only contraceptives (POCs) have not been extensively studied, but one large registry study did show a significantly increased risk of breast cancer with use of POCs. Unless there is evidence to the contrary, a similar warning should be added to all POCs. Patient-related materials should also adequately convey this risk.

  • Cervical Cancer

COCs have been linked to a significantly increased risk of cervical cancer. Similar data have been shown for POCs. A black box warning should be added to the labeling of all COCs and POCs that they have been shown to increase the risk of cervical cancer. Patient-related materials should also adequately convey this risk.

  • Inflammatory Bowel Disease

Significantly higher risk for the development of inflammatory bowel disease, especially Crohn’s disease, but also ulcerative colitis, has been shown for COCs. A black box warning should be added to the labeling of all COCs that their use is linked to a significantly increased risk for the development of inflammatory bowel disease. Patient-related materials should also adequately convey this risk.

  • Systemic Lupus Erythematosus (SLE)

Significantly higher risk for the development of SLE has been shown for COCs in several studies, especially the best-designed, largest cohort studies. A black box warning should be added to the labeling of all COCs that their use is linked to a significantly increased risk of the development of SLE. Patient-related materials should also adequately convey this risk.

  • Depression and Suicide

Substantive evidence indicates there is a 25% risk of depression for women under 25 years of age especially within 6 months of starting COCs. A black box warning should be added to the labeling of all COCs that their use is linked to a significantly increased risk of the development of depression. Patient-related materials should also adequately convey this risk. The relative risk for suicide attempts ranges from 1.91 for COC's, to 2.29 for oral progestins, 2.58 for vaginal ring and 3.28 for patch among adolescents and young women – mean age 21 years – peaking within two months of onset of medication. A black box warning should be added to the labeling of all COCs that their use is linked to a significantly increased risk of suicide. Patient-related materials should also adequately convey this risk. Close monitoring is essential especially in the first year of use.

  • Venous Thrombosis and Cardiovascular Events

The current black box warning regarding thrombotic events on some formulations, notes “WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS.” This is misleading and has shown to be misinterpreted by many women who infer that the increased risk only occurs with cigarette smoking and/or with being over 35 years of age. The warnings should be amended to state, “WARNING: INCREASED RISK OF SERIOUS CARDIOVASCULAR EVENTS INCLUDING BLOOD CLOTS.” This warning should be required for hormonal birth control products including oral, intravaginal and transdermal formulations. The patient-related materials should clearly explain the genetic risk factors, other risk factors, and the signs and symptoms. This warning should be included in ALL direct-to-consumer advertising (television, print, radio, etc.)

Additional safety information which should be added:'

  • Multiple Sclerosis (MS)

Significantly higher risk for the development of MS has been shown for COCs in several studies, especially the best-designed, largest case-control studies. A warning should be added to the labeling of all COCs that their use appears to be linked to a significantly increased risk of the development of MS. Patient-related materials should also adequately convey this risk.

  • Bone Fractures

Use of POCs is clearly associated with a higher risk of bone fractures. A warning should be added to the labeling of all POCs that their use is linked to a significantly increased risk of the development of bone fractures. Patient-related materials should also adequately convey this risk. Protracted use of COCs has been associated with an increased risk of bone fractures. A warning should be added to the labeling of all COCs that their prolonged use may be linked to a significantly increased risk of the development of bone fractures. Patient-related materials should also adequately convey this risk.

  • Body Mass Effects

For ANY progestin-releasing IUD: Add to professional label in side effects/precautions:

Progestin-releasing IUDs (IUCs) have demonstrated in clinical trials to significantly increase % fat body mass with a corresponding decrease in % lean body mass over 1 year of use.

Add to patient-related materials:

Use of (Brand name) may increase the percent of fat in your body while decreasing the percent of lean body mass; this change in body composition is known to increase risk of other serious conditions such as diabetes and cardiovascular problems.

This warning should be included in all direct-to-consumer advertising (television, print, radio, etc.) as it demonstrates use of IUCs may contribute to other serious chronic health conditions.Similar labeling should be considered for progestin-only contraceptives. Although the current evidence is less, it tends in the same direction.

  • Urogenital Problems

Interstitial Cystitis: Significantly higher risk for the development of interstitial cystitis has been shown for COCs in two studies. A warning should be added to the labeling of all COCs that their use appears to be linked to a significantly increased risk of the development of interstitial cystitis. Patient-related materials should also adequately convey this risk. COCs have also been linked to an increased risk of bacteriuria, urinary tract infections, bladder trabeculation, vulvovaginal candidiasis, vaginal dryness, vulvar vestibulitis, and Female Sexual Dysfunction (FSD) caused by OC-induced dyspareunia and reduced sexual desire and libido. These risks should be adequately conveyed in the prescribing information, especially FSD where there is substantial literature evidence.

BMJ Rapid Response on 'Oestrogen-containing contraceptive pills' study of August 2016

Following publication of Use of Estrogen-Containing Contraception Is Associated With Increased Concentrations of 25-Hydroxy Vitamin D there followed a lively debate on BMJ Rapid Responses.

Of particular note is the response below, by Ellen CG Grant, Physician and medical gynaecologist,Retired, to be found at BMJ Research News Rapid Responses re Oestrogen-containing contraceptive pills and vitamin D levels study. Grant commences by saying that -

Stavros Saripanidis responds to the news that small increases circulation vitamin D levels in oral contraceptive users may lower mortality. What is the reality?''

This Rapid Response then goes on to state that:

In 2007 cancer prevention was claimed by the RCGP [Royal College of General Practitioners] study authors but disputed in BMJ rapid responses. Doeren questioned the validity of findings due to cumulative exposure to both oral contraceptives and hormone therapy. Brind observed that the authors exclusion of past never users demonstrated methodological impropriety. Longer users had more and longer lasting cancer and breast cancer risks than previously suspected. Their conclusion that “in this relatively healthy UK cohort, cancer benefits associated with oral contraception outweigh the risks” was irresponsible. Grant questioned Hannaford’s unwillingness to accept the implications for follow-up studies which chose to include older women, 50% of whom are likely to have started HT [Hormone Therapy] in their 40s or 50s, as never users of hormones. The RCGP flawed analysis still found that more than eight years of OC [Oral Contraceptives] use increased the risk of invasive cervical cancer x 2.75 and central nervous system or pituitary tumours x 5.51.''

and then:

It should have been shocking that in the 2010 RCGP mortality follow-up, three times more OC takers below age 30 years died than never takers. Also, women under age 45 years who stopped using OCs 5-9 years previously had an increased risk of death from any cause. Circulatory deaths doubled in current and recent users up to 5-9 years after stopping OCs. Users had an increased death rate from all cancers combined including breast cancer. Three out of four of all study deaths were recorded in the fourth and final decade when OC use was long past, and, as all women were older than 50 years, half of them were likely to be taking HT but, importantly, such use was no longer being recorded by the RCGP authors. Contamination of never OC user controls with users of the same or similar hormones given for different reasons invalidates claims of reduced mortality.

This Rapid Response includes the following references:

1 Susan Mayor . Oestrogen-containing contraceptive pills increase vitamin D levels study finds. BMJ 2016;354:i4345.
2 Harmon QE, Umbach DM, Baird DD. Use of estrogen-containing contraception is associated with increased concentrations of 25-hydroxy vitamin D. J Clin Endocrinol doi: 10.1186/s12916-015-0484-3.
3 Ellen Grant www.harmfromhormones.co.uk
4 Merritt MA, Riboli E, Murphy N. Reproductive factors and risk of mortality in the European Prospective Investigation into Cancer and Nutrition; a cohort study. BMC Med. 2015; 13: 252. doi: 10.1186/s12916-015-0484-3
5 Royal College of General Practitioners. Oral Contraceptives and Health. 1974 Pitman Medical, London.
6 Royal College of General Practitioners. Oral contraception study: some recent observations 1984;11 759-86.<br? 7 Kay CR. Hannaford PC. Breast cancer and the pill. A further report from the Royal College of General Practitioners’ Oral Contraceptive Study. Br J Cancer 1988;675-80.
8 Beral V, Hannaford PC, Kay C. Oral contraceptive use and malignancies of the genital tract. Lancet 1988;ii:1331-5.
9 Hannaford PC. Selvaraj S, Elliot A M, Angus V, Iverson L, Lee AJ. Cancer risk among users of oral contraceptives: cohort data from the Royal College of General Practitioner's oral contraception study. BMJ 2007:335(7621);651.
10 Doeren M. Validity of findings and interpretation of core results of the Royal College of General Practitioners` oral contraception study are questionable. BMJ 2007;335:651. Rapid Response,14 September 2007.
11 Brind J. General Practitioner’s oral contraceptive study reveals greater; not lesser cancer risks. BMJ 2007;335:651. Rapid Response, 14 December 2007.
12 Grant ECG. Flawed RCGP Pill study underestimates cancer risks from use of progestogens and oestrogens. BMJ 2007;335:651. Rapid Response, 22 January 2008.
13 Hannaford PC, Iversen L, Macfarlane TV, Elliott AM, Angus V, Lee AJ. Mortality among contraceptive pill users: cohort evidence from Royal College of General Practitioners' Oral Contraception Study. BMJ 2010; 340: c927.
14 Charlton BM, Rich-Edwards JW, Colditz GA, Missmer SA, Rosner BA, Hankinson SE, Speizer FE, Michels KB. Oral contraceptive use and mortality after 36 years of follow-up in the Nurses’ Health Study: prospective cohort study. BMJ 2014;349:g6356.
15 Grant ECG. Re: Oral contraceptive use and mortality after 36 years of follow-up in the Nurses’ Health Study: prospective cohort study. BMJ 2014; 349/bmj.g6356/rapid-responses 1 November 2014.
16 Breen EG. Re: Oral contraceptive use and mortality after 36 years of follow-up in the Nurses’ Health Study: prospective cohort study. BMJ 2014; 349/bmj.g6356/rapid-responses 3 November 2014
17 Grant ECG. The pill, hormone replacement therapy, vascular and mood over-reactivity and mineral imbalance. J Nutr Environ Med 1998:8:789-91. DOI:10.1080/13590849862131

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