Women Receiving Hormonal Contraceptives for Acne Experience More Adverse Events and Thromboembolism
It was determined that women taking combined hormonal contraceptives (CHCs) for acne, who are young actually experienced a higher proportion of serious events (RR=1.04, p=0.007) and VTE events (RR=1.47, p<0.0001).
Almost all (92.7%) reports of AE and venous thromboembolism (VTE) experienced by patients prescribed CHCs for acne contained within the FDA Adverse Events Reporting System (FAERS) involved CHCs containing drospirenone. These data are being presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting.
“These results challenge our assumptions that relative risk of adverse events is comparable for all CHC indications. Our results highlight the importance of counseling patients prescribed CHCs for acne treatment about increased risk of blood clots and other available treatment options. Large retrospective case-control studies, individual chart review, and prospective cohort studies are needed to further examine the pathophysiology behind acne, hormones, and higher AE and VTE risk,” wrote lead author Elizabeth Rao, BS, Case Western Reserve University School of Medicine, Cleveland, and colleagues.
Researchers downloaded data on all adverse events from 1989 until 2021 for the 15 most common CHCs, and arrived at a database of 13,116 reports. The majority of reports occurred in 2010 and 2011. Due to gaps within the reporting database, however, researchers were unable to control for other risk factors for VTE, such as concomitant medications, obesity, smoking, or thrombophilias.
As the authors had assumed, women in the acne group were younger on average (p<0.0001); yet the acne group had a higher proportion of serious events (RR=1.04, p=.007) and VTE events (RR=1.47, p<.0001)
Drospirenone-containing COCs had a higher relative risk of VTE events compared to other COCs regardless of prescription indication (RR=1.6, p<.0001).
Reference
Rao E, Carroll B. Serious adverse events associated with hormonal contraceptive use for acne treatment, based on reporting to the FDA Adverse Events Reporting Database. Poster presented at: AAD Annual Meeting; March 25-29, 2022. Boston, MA.
