Summary Safety Review - Hormonal Birth Control Products (excluding Emergency Birth Control Products) - Assessing the Potential Risk of Suicidal Thoughts and Behaviours (suicidality)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2019-08-06

Product

Hormonal Birth Control Products (including oral contraceptive pills, transdermal patch, vaginal ring, intrauterine contraceptive device [IUD], and injectable contraception)a

Potential Safety Issue

Suicidal Thoughts and Behaviours (Suicidality)

Key Messages

  • Hormonal birth control products are prescription drugs and medical devices that contain hormones and are used to prevent pregnancy. Many hormonal birth control products are authorized for sale in Canada; for a complete list, see footnote.a
  • Health Canada reviewed the potential risk of suicidal thoughts and behaviours (suicidality) with the use of hormonal birth control products. This review was triggered by a safety review conducted by the European Medicines Agency (EMA).
  • Health Canada's review of the available information found that there is not enough evidence at this time to support a link between the use of hormonal birth control products and the risk of suicidality.
  • The product safety information for hormonal birth control products in Canada currently includes warning statements about the risk of depression and mood changes.
  • Based on the evidence reviewed, no revisions to the product safety information were deemed necessary and the current labelling was found to sufficiently address the risks of depression and mood changes.
  • Health Canada will continue to monitor safety information involving hormonal birth control products, as it does for all health products on the Canadian market.

Overview

Health Canada's review of the potential risk of suicidal thoughts and behaviours (suicidality) with the use of hormonal birth control products was triggered by a safety review conducted by the EMA. The EMA's safety review was based on a published study suggesting a higher risk of suicide/first suicide attempts among users of hormonal birth control products compared to non-users. The risk was found to be higher for the hormone-containing patch placed on the skin (transdermal patch), the vaginal ring and progestin-only products, in comparison to the combined oral contraceptive (COC) products.1 The EMA's safety review led to an update to the European product safety information with a new warning statement about the risk of depression with the use of hormonal birth control products (similar to the current Canadian warning), linking suicidality to depression in severe cases. It is important to note that depression is the most common illness diagnosed among those who commit suicide, and it is well known that severe depression could lead to suicide.2

In Health Canada's review, suicidality was defined as suicidal thoughts and behaviours (completed suicide, suicide attempt, preparatory acts towards imminent suicidal behaviour, and serious thoughts about taking one's own life). Health Canada assessed the risk of suicidality for each type of hormonal birth control producta to determine if there was a need for further monitoring and/or the implementation of additional risk minimization measures.

Use in Canada

  • Hormonal birth control products have been used for many decades to prevent pregnancy.
  • They are considered to be one of the most widely used pharmaceuticals by women worldwide. In Canada, hormonal birth control products are broadly used, with more than 10 million prescriptions dispensed in 2018.b
  • Over the last 6 years, combined oral contraceptive (COC) products with ethinyl estradiol and levonorgestrel (e.g., Alesse, Alysena, Aviane, Indayo, Lutera, Mini-Ovral, Ovima, Portia, Seasonique, Triquilar) were the birth control products most commonly dispensed in Canada.

Safety Review Findings

  • At the time of the review, Health Canada had received 121 Canadian reportsc for suicidality since January 1, 1965. After screening all reports, 98 reports were excluded, mainly for the lack of information. As such, 23 case reports underwent assessment as part of this review, of which 11 were related specifically to Depo-Provera (an injectable hormonal birth control product). Based on the review, a link between the use of hormonal birth control products and the potential risk of suicidality was found to be likely in 1 report, possible in 20 reports and could not be assessed in 2 reports. Serious thoughts about suicide was the most common event in these reports.
  • Of the 20 reports where the link between the use of hormonal birth control products and the potential risk of suicidality was deemed possible, only 1 case report was of a completed suicide. In this case, the patient was using the hormonal birth control Depo-Provera. However, there were also other significant factors which may have contributed to this suicide, besides the use of Depo-Provera.
  • The product safety information for all hormonal birth control products in Canada includes a warning statement about the risk of depression/mood changes. The risk of suicidality is specifically listed in the product safety information for Depo-Provera. The majority (11/23) of the Canadian reports assessed assessed as part of this review were related to Depo-Provera.
  • The link between the use of hormonal birth control products and the risk of suicidality remains unclear, however scientific and medical literature seems to supports a link between depression/mood changes and the use of hormonal birth control products.

Conclusions and actions

  • Health Canada's review concluded that there was not enough evidence to support a direct link between the use of hormonal birth control products and the risk of suicidality.
  • The current Canadian labelling of hormonal birth control products includes a warning about the risk of depression/mood changes. Suicidality is specifically labelled for Depo-Provera.
  • Health Canada will continue to monitor safety information involving hormonal birth control products to identify and assess potential risks, as it does for all health products on the Canadian market. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of these drugs both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

  1. Skovlund CW, Morch LS, Kessing LV, Lange T and Lidegaard O. Association of Hormonal Contraception with Suicide Attempts and Suicides. Am J Psychiatry 2017, appiajp201717060616.
  2. Mocicki EK. Epidemiology of completed and attempted suicide: Toward a framework for prevention. Clinical Neuroscience Research. 2001; 1:310-23.

Footnotes

  1. Authorized Hormonal Contraceptivess in Canada include: Levonorgestrel (Jaydess, Kyleena, Mirena, etc); Etonogestrel/Ethinyl estradiol (prnuvaring®); Desogestrel (Apri 21, Apri 28, linessa 28); Norgestrel (Lo-femenal 21); Norgestimate (Centrisa 21, Centrisa 28); Norethindrone acetate (Loestrin 1.5/30, lolo); Norethindrone (Brevicon 0.5/35 tablets); Ethynodiol diacetate (Demulen); Medroxyprogesterone acetate (Depo-provera sterile aqueous suspension); Norelgestromin (Evra); Estradiol valerate (Natazia); Drospirenone (Drospirenone and Ethinyl estradiol, Mya, Nikki, Yasmin, Yaz, Zamine, Zarah); Ethinyl estradiol (Ovral); Cyproterone acetate (Cléo, Cyestra, Diane, etc); Progesterone (Act progesterone injection); Medroxyprogesterone acetate (Apo-medroxy, Medroxy, Meprogest, Nu-Medroxy, etc).
  2. For this report, the Marketed Health Products Directorate of Health Canada used the IQVIA Canadian Drug Store (Compuscript database [CS]), which measures the dollar value and unit volume of pharmaceutical products purchased by Canadian retail pharmacy outlets. Data for CS are collected from a representative sample of 2998 drug stores (November 2018). The sample data are then projected to the universe of drug stores, to reflect all purchases across Canada.
  3. Canadian reports can be accessed through the Canada Vigilance Online Database.

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