Important Risk Information

What is the most important information I should know about Slynd (drospirenone)?

What is Slynd?
Slynd is a birth control pill (oral contraceptive) also called a POP (progestin only pill) that is used by women who can become pregnant to prevent pregnancy.

Do not take Slynd if you:

  • have kidney disease or kidney failure
  • have reduced adrenal gland function (adrenal insufficiency)
  • have or have had cervical cancer or any cancer that is sensitive to female hormones
  • have liver disease, including liver tumors
  • have unexplained vaginal bleeding

If any of these conditions happen while you are taking Slynd, stop taking Slynd right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Slynd.

Before you take Slynd, tell your healthcare provider about all your medical conditions, including if you:

  • are pregnant or think you may be pregnant
  • have ever had blood clots in your legs, lungs, a stroke, or a heart attack
  • have high levels of potassium in your blood or take chronic medications that may increase blood potassium concentrations

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements, such as St. John’s Wort.
Slynd may affect the way other medicines work, and other medicines may affect how well Slynd works.
Consider using an alternative or back-up method of contraception when such medicines are used with Slynd.

What are the possible serious side effects of Slynd?
Slynd may cause serious side effects, including:

  • High potassium levels in your blood- your healthcare provider may check your blood potassium levels before and during treatment with Slynd.
    Seek medical help right away if you have weakness/numbness in an arm or leg, irregular heartbeat or your heart is racing/fluttering, nausea, vomiting, severe pain in chest, or shortness of breath.
  • Blood clot forming in blood vessels – tell your healthcare provider if you plan to have surgery or are not able to be active due to illness or injury. Risk of clots may be higher in the weeks after giving birth.
  • Seek medical help right away if you have leg pain that will not go away, a sudden severe headache, sudden severe shortness of breath, a sudden change in vision or blindness, chestpain, weakness/numbness in arm or leg, or trouble speaking.
  • Bone loss – it is unknown if the decrease in estrogen that happens with Slynd can result in decreased bone density

Slynd (drospirenone) – Patient ISI

  • Liver problems, including rare liver tumors – seek medical help right away if you have yellowing of the skin or eyes
  • Ectopic pregnancy – a pregnancy outside the uterus. Seek medical help right away if you have severe abdominal (belly) pain as this type of pregnancy is a medical emergency and often requires surgery.
  • Risk of high blood sugar levels in people with diabetes – you may need to monitor your blood sugar level more often or adjust your diabetes medicine.
  • Changes in menstrual bleeding – tell your healthcare provider if you experience irregular vaginal bleeding, irregular periods, or an absence of period

What are the most common side effects of Slynd?
The most common side effects reported by women taking Slynd were acne, menstrual cramps, headache, breast pain and tenderness, weight gain, nausea, severe vaginal bleeding, less sexual desire, and irregular menstruation.

What else should I know about taking Slynd?
If you are scheduled for any lab tests, tell your healthcare provider you are taking Slynd. Certain blood tests may be affected by Slynd.

Slynd does not protect against HIV infection (AIDS) and other sexually transmitted infections.

Discontinue Slynd if pregnancy occurs.

These are not all the possible side effects and risks of Slynd. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088. You may also report side effects to Exeltis by calling 1-877-324-9349.

Please see the full Prescribing Information, including Patient Information for complete safety and risk information regarding Slynd.

References (click to expand)

1. Villavicencio J, Allen RH. Unscheduled bleeding and contraceptive choice: increasing satisfaction and continuation rates. Open Acc J Contracept. 2016;7:43-52. doi: 10.2147/OAJC.S85565
2. Slynd [package insert]. Exeltis USA, Inc.; Florham Park, NJ; 2019.
3. Data on file. Exeltis USA, Inc.; Florham Park, NJ; 2019.
4. Fuhrmann U, Krattenmacher R, Slater ED, et al. The novel progestin drospirenone and its natural counterpart progesterone: biochemical profile and antiandrogenic potential. Contraception. 1996;54(4):243-251
5. Regidor PA, Schindler AE. Antiandrogenic and antimineralocorticoid health benefits of COC containing newer progestins: dienogest and drospirenone. Oncotarget. 2017:8 (47): 83334-83342.
6. Vroonen L, Cavalier E, Vranken L, et al. Influence of drospirenone on renin-angiotensin-aldosterone system evaluation. Endocrine Abstracts. 2011;26:12.
7. Slopien R, Milewska E, Rynio P, et al. Use of oral contraceptives for management of acne vulgaris and hirsutism in women of reproductive and late reproductive age. Menopause Review. 2018;17(1):1-4. doi: 10.5114/pm.2018.74895
8. Greer JB, Modugno F, Allen G, et al. Androgenic progestins in oral contraceptives and the risk of epithelial ovarian cancer. Obstet Gynecol. 2005;105:731-740.
9. Batur P. Female contraception. Cleveland Clinic Center for Continuing Education. Published December 2016.
10. Glisic M, Shahzad S, Tsoli S, et al. Association between progestin-only contraceptive use and cardiometabolic outcomes: a systematic review and meta-analysis Eur J Prev Cardiol. 2018;25(10):1042-1052. doi: 10.1177/2047487318774847.
11. Duijkers IJM, Heger-Mahn D, Drouin D, et al. Maintenance of ovulation inhibition with a new progestogen-only pill containing drospirenone after scheduled 24-h delays in pill intake. Contraception. 2016:93(4): 303-309.

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