Bayer responds to YAZ and Yasmin media report
The Medical Director of Bayer Australia, Dr Jan Twomey, states on behalf of Bayer that the prime time national TV segment contained irresponsible and inaccurate claims concerning its combined oral contraceptives YAZ (ethinyloestradiol 20mcg (as betadex clathrate), drospirenone 3mg tablet) and Yasmin (ethinyloestradiol 30mcg, drospirenone 3mg tablet).
“At Bayer patient safety comes first,” Dr Jan Twomey said.
“There are no new data on the benefit-risk profile of YAZ and Yasmin. Based on a thorough assessment of the available scientific data by regulatory authorities, external independent experts and Bayer scientists, drospirenone-containing combined oral contraceptives have a positive risk benefit profile when used as directed. There is no agreement in the scientific literature about whether different progestins used in COCs have a different risk with regard to VTE. There have been several studies showing no difference in risk between progestins while others have reported a difference between progestins. The individual study results may be influenced by the strengths and limitations of each study.1 All the available data has previously been provided to the Therapeutic Goods Administration (TGA).
“The increased risk of venous thromboembolism is very small and lower than the risk of thromboembolism in pregnancy.2 The use of combined oral contraceptives is not the only risk factor for venous thromboembolism; factors such as older age, smoking, inherited coagulation abnormalities, obesity, pregnancy and the immediate post-partum period, malignancy and prolonged immobilisation have all been shown to increase the risk of venous thromboembolism.
“All combined oral contraceptives carry risks, including an increased risk of thromboembolism. This risk has been recognised for many years3 and is outlined in both the Product Information (PI) supplied to doctors, and the Consumer Medicine Information (CMI) supplied with the product to women prescribed the pill.
“We take the safety of our medicines very seriously and always closely collaborate with the respective health and regulatory authorities, as well as medical professionals, to exchange all relevant information concerning the use and the benefit-risk profile of our products,” she said.
Prescribing doctors should be aware of the risks associated with combined oral contraceptives including YAZ and Yasmin, and will need to take them into consideration when discussing and prescribing the most appropriate contraceptive for a woman.
Any woman concerned about her oral contraceptive should speak to her doctor.
If doctors and pharmacists have any questions, please contact Bayer Medical Information on 1800 673 270.
Further media enquiries:
(02) 9391 6009
0419 705 593
(02) 9391 6277
0439 656 175
1 YAZ® and Yasmin® approved Product Information. 31 January 2013
2 Szarewski A, Mansour D, Shulman LP. 50 years of “The Pill”: celebrating a golden anniversary. J Fam Plann Reprod Health Care 2010; 36(4): 231–238
3 Heit JA, Kobbervig CE, James AH et al. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30 year population based study. Ann Intern Med. 2005; 143:697-706.