logo
Share SHARE
FONT-SIZE Plus   Neg

Bayer Updates US Labels For Drospirenone-containing Combined Oral Contraceptives

Bayer HealthCare, a subgroup of Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK), said the company and U.S. Food and Drug Administration, or FDA, have agreed to update the labels for its drospirenone-containing combined oral contraceptives, or COCs, in United States.

The updated labels in the U.S. include additional information from recently published studies evaluating the risk of venous thromboembolism (blood clots) in women taking drospirenone-containing COCs. Mainly, the new U.S. labels state that COCs containing drospirenone may be associated with a higher risk of venous thromboembolism, or VTE, than COCs containing levonorgestrel or some other progestins, Bayer HealthCare noted.

Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. The U.S. labels state that before initiating use of drospirenone-containing COCs in a new COC user or a woman who is switching from a contraceptive that does not contain drospirenone, consider the risks and benefits of a drospirenone containing COC in light of her risk of a VTE.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
HSBC is reportedly laying off about 100 of its senior investment bankers worldwide, as the banking giant strives to curb operating costs. According to reports, the London-headquartered bank will eliminate managing director and director level employees at the Global Banking and Markets division, as... Samsung Electronics Co., Ltd. (SMSN.L, SSNNF.OB, SSNLF.OB) will reportedly blame faulty batteries for last year's Galaxy Note 7 fiasco. According to a Wall Street Journal report, Samsung's investigation of Galaxy Note 7 smartphones found that some batteries were irregularly sized while others had... Federal investigators have closed their probe of a fatal crash that involved a Tesla Motors Inc. car eight months ago. The regulators said they have found no safety defects in the vehicle's automated driving system and that Tesla's Autopilot-enabled vehicles did not need to be recalled.
comments powered by Disqus
Follow RTT