Safety of a New Oral Contraceptive Containing Drospirenone

  title={Safety of a New Oral Contraceptive Containing Drospirenone},
  author={Lothar A. J. Heinemann and J{\"u}rgen C Dinger},
  journal={Drug Safety},
New chemical entities must undergo rigorous, and preferably independent, safety and efficacy assessments before entry into the market. This is also true for oral contraceptives (OCs) given their extensive usage by healthy women and the safety concerns highlighted by the so-called ‘third generation pill scare’ in Europe a decade ago. This scare heightened patient and physician awareness of the increased risk of thromboembolic complications (mainly venous thromboembolism [VTE]) associated with OC… 

The association between drospirenone and hyperkalemia: a comparative-safety study

Despite the bolded warning for hyperkalemia with joint drospirenone and spironolactone administration, physicians are actually using them together preferentially, and are not following the recommended potassium monitoring requirements in the package insert.

Irritable bowel syndrome and drospirenone-containing oral contraceptives; a comparative-safety study.

A positive association between drospirenone and a diagnosis of IBS that was not observed with other OCs was found, and multiple sensitivity analyses confirmed this association.

Combined hormonal contraception and venous thromboembolism

  • F. MartínezÀ. Avecilla
  • Medicine, Biology
    The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception
  • 2007
The greatest risk of COC-associated VTE occurs during the first year of use, thus suggesting the existence of a predisposing condition, such as being a carrier of a thrombogenic mutation with which the COCs would exert a synergistic effect.

Arterial thrombosis and drospirenone-containing pill (Yasmin). Is the pill to be absolutely avoided by women who smoke?

It seems safe to underscore that smokers even moderate ones should abstain from OC intake or vice versa should stop smoking while on the medication, especially so for drospirenone-containing preparations.

Risk of Thromboembolism in Women Taking Ethinylestradiol/Drospirenone and Other Oral Contraceptives

Ethinylestradiol/drospirenone initiators and initiators of other oral contraceptives are similarly likely to experience thromboembolism.

Rate of Pregnancy After Using Drospirenone and Other Progestin-Containing Oral Contraceptives

Previous oral-contraceptive use does not negatively affect initial and 1-year rates of pregnancy after oral- Contraceptive cessation, and a comparison of these data with data external to this study indicates that the negative effect of aging on fecundity is not amplified by oral-contained use.



The role of selective prescribing in the increased risk of VTE associated with third-generation oral contraceptives.

Re-analysis of the data has shown that the thrombotic risk factors are increased in third-generation OC users but, more importantly, that those users (unlike those using second-generation pills) are the women who have not had the opportunity of revealing a latentThrombophilia and are, therefore, at a greater risk of expressing it during third- generation OC intake.

The differential risk of oral contraceptives: the impact of full exposure history.

The Transnational Study data show no evidence for an increased risk of VTE with third- compared with second-generation combined oral contraceptives, and adjustment for past exposures includes more information and appears more valid than the standard cross-sectional analysis.

The effect of 2 combined oral Contraceptives containing either drospirenone or cyproterone acetate on acne and seborrhea.

EE/DRSP has been shown to be as effective for treating mild-to-moderate acne as a preparation containing EE/CPA, and this new preparation may provide useful hormone therapy for women with androgen-dependent disorders who also require contraception.

Drospirenone: a new cardiovascular-active progestin with antialdosterone and antiandrogenic properties.

  • A. Rübig
  • Biology, Medicine
    Climacteric : the journal of the International Menopause Society
  • 2003
Phase III studies with E2/DRSP show that DRSP does not antagonize the well-documented reductions of blood pressure associated with E1; rather, small DRSP dose-related reductions in systolic and diastolic blood pressures were observed, which should be beneficial for recipients, especially those who are mildly hypertensive.

Recent oral contraceptive use patterns in four European countries: evidence for selective prescribing of oral contraceptives containing third-generation progestogens.

Physicians have selectively been prescribing third-generation OCs to women at increased risk of cardiovascular disease because of this perceived better safety profile, which may have seriously biased the results of the recently published studies on OCs and venous thromboembolism.