Interactions Between Emergency Contraception and Other Hormonal Contraceptives

The American Society for Emergency Contraception (ASEC) recently held their annual EC Jamboree in Washington, DC. Participants included health care providers, researchers, reproductive health advocates, and pharmaceutical stakeholders.

One highlight was the key clinical discussions centered on drug interactions between emergency and other hormonal contraceptives, including ulipristal acetate (ella, Afaxys Pharma).

A selective progesterone receptor modulator, ulipristal acetate binds the progesterone receptor, and has both antagonistic and partial agonistic effects. When ulipristal acetate is in the picture, along with another progestin hormone, there will be competition for the progesterone receptors. For this reason, the patient’s use of another progestin-containing hormonal contraceptive either before or after may impact its effectiveness [1]

This theory is based on the pharmacology of the drugs and was supported by a European study. The study looked at the impact of starting a desogestrel progestin-only pill the day after taking ulipristal acetate, compared to starting the same progestin-only pill without ulipristal acetate beforehand. The group that had taken ulipristal acetate showed a slower onset of action of the progestin-only pill in preventing ovulation and thickening the cervical mucus. This particular progestin-only pill is not available in the United States [1]

Following this study, Afaxys revised the ulipristal acetate label in March 2015 to include: “Hormonal contraceptives: Progestin-containing contraceptives may impair the ability of ella to delay ovulation … Avoid co-administration of ella and hormonal contraceptives. If a woman wishes to start or resume hormonal contraception after the intake of ella, she should do so no sooner than 5 days afterwards, and she should use a reliable barrier method until the next menstrual period.“ [2]

Last year, another study found that combined oral contraceptives containing estrogen and progestin hormones are expected to reduce efficacy of ulipristal acetate, as well. In this United States study, researchers evaluated the impact of initiating an ethinyl estradiol/levonorgestrel combined pill 2 days after ulipristal acetate use [3]. More participants experienced ovulation when the combined pill was initiated compared to those who did not initiate any hormones after ulipristal acetate.

Pharmacists and pharmacy staff can refer to a 1-page guide created by ASEC, available on the organization’s website at americansocietyforec.org, for additional information on FDA-approved emergency contraceptives.

References

  1. Brache V, Cochon L, Duijkers IJ, et al. A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception. Hum Reprod. 2015;30(12):2785-2793.
  2. Ulipristal acetate (ella) prescribing information. May 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=052bfe45-c485-49e5-8fc4-51990b2efba4
  3. Edelman AB, Jensen JT, McCrimmon S, Messele-Forbes M, O’Donnell A, Hennebold JD. Combined oral contraceptive interference with the ability of ulipristal acetate to delay ovulation: A prospective cohort study. Contraception 2018;98(6):463-466.

This article was originally published in Pharmacy Times.

FDA Updates on Birth Control

There have been some notable changes with birth control products, including three new product approvals and one product exiting the market.

1. New yearly birth control vaginal ring approved. This birth control ring is very different from the existing vaginal ring product since it works for 1 year. It is a combined hormonal product and contains ethinyl estradiol and a new progestin — segesterone acetate. The ring is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year. The brand name is Annovera. One advantage of this product is that it does not require refrigeration. It is expected to be available in 2019. For more info, FDA News Release and Manufacturer Press Release.

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2.  First direct-to-consumer birth control digital app approved. This is the first app approved by the FDA as a safe and effective method of contraception.  It is indicated for use by adults aged 18 years and older. The app must be used with a thermometer — a two decimal basal thermometer, which is not the same as a normal fever thermometer.

Users will measure their temperature first thing in the morning before they get up and out of bed (at least five mornings a week) and enter it into the app.  For the algorithm to calculate daily fertility, users will also need to add their period data each month. The Natural Cycles algorithm analyses the information entered into the app to detect ovulation, thereby identifying green days, when no protection is needed, or red days, when you should use condoms or abstain from sex to prevent a pregnancy. For more info, FDA News Release and Company Website.

Natural Cycles Birth Control App

3. Another generic levonorgestrel emergency contraceptive pill approved. New generic emergency contraception (EC) pill approved. Preventeza is the brand name and it is made by the makers of Vagisil. This is another Levonorgestrel 1.5 mg single-pill EC product that may be sold without a prescription to consumers of all ages — women and men. It is available online only from the manufacturer’s website.

Preventeza Emergency Contraception

4. Essure to be discontinued. Essure is a permanent birth control method that doesn’t requires surgery and is placed in an office-based procedure. In this procedure, a soft, flexible insert is delivered through the vagina and uterus and permanently placed in each fallopian tube. No incision is required to deliver or place the inserts and general anesthesia is not required. Over time, a natural barrier forms around the inserts and prevents sperm from reaching the eggs by occluding the fallopian tubes. During this time, the patient must continue using another form of birth control to prevent pregnancy until the confirmation test at 3 months post-procedure.

The manufacturer is discontinuing production and it will no longer be available at the end of 2018.  This may be due to complaints from users due to adverse effects, restrictions by the FDA in April of this year, and/or low utilization. For more info, FDA Press Announcement.

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This has been a busy time for birth control product changes. We always welcome new birth control options to fit patient needs, given they are safe and effective.