Risk of venous thromboembolism with drospirenone-containing oral contraceptives. 2011

Dana A Brown, and Christine M Vartan
Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, FL, USA. dana_brown@pba.edu

OBJECTIVE The risk of venous thromboembolism (VTE) with drospirenone-containing oral contraceptives (OCs) is reviewed. CONCLUSIONS Increasing attention and media have raised awareness and concern about whether drospirenone-containing OCs increase the risk of VTE. Two studies found that when compared with nonuse of OCs, use of drospirenone-containing OCs was associated with a fourfold to over sixfold increased risk of having a thrombotic event. One of these studies found an increased risk associated with short-term use of drospirenone-containing OCs; however, this study was limited by the small number of participants taking drospirenone despite the large number of study participants. The cohort study that found a higher rate of VTE among drospirenone users was only able to indicate an association between drospirenone use and VTE, not a cause-and-effect relationship. Three studies concluded that drospirenone-containing OCs did not appear to cause an increased risk of VTE. The hemostatic studies found no difference in the various variables assessed between drospirenone- and desogestrel-containing OCs or between cyclic and continuous administration of drospirenone-containing OCs. These results should be interpreted cautiously, as each study had limitations, such as not controlling for confounders (e.g., recent surgery, immobility, obesity), not providing p values to assess homogeneity between treatment groups, and not providing total numbers of participants or specific types of OCs. Patients who receive drospirenone-containing OCs should be educated regarding the signs and symptoms of VTE, along with an appropriate action plan. CONCLUSIONS The majority of available data does not support the conclusion that drospirenone-containing OCs pose an increased risk of VTE compared with other OCs.

UI MeSH Term Description Entries
D010353 Patient Education as Topic The teaching or training of patients concerning their own health needs. Education of Patients,Education, Patient,Patient Education
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D003277 Contraceptives, Oral, Combined Fixed drug combinations administered orally for contraceptive purposes. Combined Oral Contraceptive,Contraceptive Agents, Female, Combined,Oral Contraceptives, Combined,Combined Oral Contraceptives,Contraceptive, Combined Oral,Contraceptives, Combined Oral,Oral Contraceptive, Combined
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000736 Androstenes Unsaturated derivatives of the steroid androstane containing at least one double bond at any site in any of the rings.
D012306 Risk The probability that an event will occur. It encompasses a variety of measures of the probability of a generally unfavorable outcome. Relative Risk,Relative Risks,Risk, Relative,Risks,Risks, Relative
D054556 Venous Thromboembolism Obstruction of a vein or VEINS (embolism) by a blood clot (THROMBUS) in the blood stream. Thromboembolism, Venous

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