FDA Issues Safety Communication for Drospirenone

June 24, 2011

In a recent safety communication, the FDA has informed the public about new information they are assessing in an ongoing review of birth control pills that contain drospirenone, a type of progestin.

In a recent safety communication, the FDA has informed the public about new information they are assessing in an ongoing review of birth control pills that contain drospirenone, a type of progestin.1

 

All birth control pills pose some risk of blood clots. However, two recently published studies have reported an increased risk of venous thromboembolic events (VTEs), including deep vein thrombosis and pulmonary embolism, for women taking oral contraceptives containing drospirenone as compared with the risk in women taking pills containing levonorgestrel, another type of progestin.2,3 Other studies have not reported an increased risk of VTEs developing. Therefore, the FDA is evaluating the conflicting results and looking at all available information to fully assess the risks and benefits of drospirenone-containing birth control pills (Table).

 

Table. Approved Oral Contraceptives Containing Drospirenone

Generic NameBrand Name
Drospirenone and ethinyl estradiolGianvi, Loryna, Ocella,
 Syeda, Yasmin, Yaz, Zarah
Drospirenone, ethinyl estradiol, and levomefolate calciumBeyaz, Safyral

Adapted from U.S. Food and Drug Administration. FDA drug safety communication: safety review of possible increased risk of blood clots with birth control pills containing drospirenone. 2011.1

References:

References
1. U.S. Food and Drug Administration. FDA drug safety communication: safety review of possible increased risk of blood clots with birth control pills containing drospirenone. Accessed June 16, 2011.
2. Parkin L, Sharples K, Hernandez RK, Jick SS. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ. 2011;340:d2139.
3. Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ. 2011;340:d2151.