The revised labels state that COCs containing drospirenone may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins.
The labels update information that the risk of VTE associated with pregnancy is even greater than the risk associated with any COC use, including drsp-containing COCs, the company said.
Epidemiologic studies which compared the risk of VTE reported that the risk ranged from no increase to a three time increase.