Drospirenone - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Drospirenone. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications ] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use drospirenone and ethinyl estradiol tablets . • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
5 WARNINGS AND PRECAUTIONS • Vascular risks : Stop drospirenone and ethinyl estradiol tablets if a thrombotic event occurs.
Stop at least 4 weeks before and through 2 weeks after major surgery.
Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins.
Before initiating drospirenone and ethinyl estradiol tablets in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. • Hyperkalemia : DRSP has anti-mineralocorticoid activity.
Do not use in patients predisposed to hyperkalemia.
Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration. ( 5.2 , 7.1 , 7.2 ) • Liver disease : Discontinue drospirenone and ethinyl estradiol tablets if jaundice occurs. • High blood pressure : Do not prescribe drospirenone and ethinyl estradiol tablets for women with uncontrolled hypertension or hypertension with vascular disease. • Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking drospirenone and ethinyl estradiol tablets.
Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. • Headache : Evaluate significant change in headaches and discontinue drospirenone and ethinyl estradiol tablets if indicated. • Uterine bleeding : Evaluate irregular bleeding or amenorrhea.
5.1 Thromboembolic Disorders and Other Vascular Problems Stop drospirenone and ethinyl estradiol tablets if an arterial or venous thrombotic (VTE) event occurs.
Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins.
Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase.
Before initiating use of drospirenone and ethinyl estradiol tablets in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.
Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications ] .
A number of studies have compared the risk of VTE for users of Yasmin (which contains 0.03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel.
Those that were required or sponsored by regulatory agencies are summarized in Table 2.
Table 2: Estimates (Hazard Ratios) of Venous Thromboembolism Risk in Current Users of Yasmin Compared to Users of Oral Contraceptives that Contain Other Progestins Epidemiologic Study (Author, Year of Publication) Population Studied Comparator Product (all are low-dose COCs; with ≤ 0.04 mg of EE) Hazard Ratio (HR) (95% CI) i3 Ingenix (Seeger 2007) Initiators, including new users a All COCs available in the US during the conduct of the study b HR: 0.9 (0.5 to 1.6) EURAS (Dinger 2007) Initiators, including new users a All COCs available in Europe during the conduct of the study c HR: 0.9 (0.6 to 1.4) Levonorgestrel/EE HR: 1 (0.6 to 1.8) “FDA-funded study” New users a Other COCs available during the course of the study d HR: 1.8 (1.3 to 2.4) Levonorgestrel/0.03 mg EE HR: 1.6 (1.1 to 2.2) All users (i.e., initiation and continuing use of study combination hormonal contraception) Other COCs available during the course of the study d HR: 1.7 (1.4 to 2.1) Levonorgestrel/0.03 mg EE HR: 1.5 (1.2 to 1.8) a. “New users” - no use of combination hormonal contraception for at least the prior 6 months b.
Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate c.
Includes low-dose COCs containing the following progestins: levonorgestrel, desogestrel, dienogest, chlormadinone acetate, gestodene, cyproterone acetate, norgestimate, or norethindrone d.
Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel In addition to these “regulatory studies,” other studies of various designs have been conducted.
Overall, there are two prospective cohort studies (see Table 2): the US post-approval safety study Ingenix [Seeger 2007], the European post-approval safety study EURAS (European Active Surveillance Study) [Dinger 2007].
An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk.
There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 2), and two from Denmark [Lidegaard 2009, Lidegaard 2011].
There are two case-control studies: the Dutch MEGA study analysis [van Hylckama Vlieg 2009] and the German case-control study [Dinger 2010].
There are two nested case-control studies that evaluated the risk of non-fatal idiopathic VTE: the PharMetrics study [Jick 2011] and the GPRD study [Parkin 2011].
The results of all of these studies are presented in Figure 1.
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