Important information about differences in thromboembolism risk of combined oral contraceptives.
Based on the totality of the data, it is concluded that the risk of VTE (deep vein thrombosis)
(deep vein thrombosis, pulmonary embolism) of individual preparations varies. For example, there is a lower risk with preparations containing the progestogens levonorgestrel, norethisterone or norgestimate. For some preparations, insufficient data are available to assess their VTE risk compared with the VTE risk of preparations with lower risk.
Combined oral contraceptives containing the following agents as progestogen components have been studied:
Chlormadinone
Desogestrel
Dienogest
Drospirenone
Etonogestrel
Gestodene
Nomegestrol
Norelgestromin and
Norgestimate.
The evaluation confirmed the previous assessment that the risk of venous thromboembolism (VTE) is low among all low-dose combined hormonal contraceptives (CHCs, ethinyl estradiol content < 50 μg).
There is clear evidence that differences exist between CHCs depending on the progestin they contain with respect to the risk of venous thromboembolism (VTE). Currently available data suggest that CHCs containing the progestogens levonorgestrel, norethisterone, or norgestimate have the lowest risk of VTE among combined hormonal contraceptives.
When prescribing CHCs, the individual woman's risk factors-particularly those for VTE-and the differences that exist among preparations in terms of VTE risk should be considered.
There is no need to discontinue the preparation if there have been no previous problems with the use of the combined hormonal contraceptive. Compared with pregnancy and the postpartum period, the risk of VTE is lower with the use of CHCs.
For most women, the benefits associated with CHC use far outweigh the risk of serious adverse events occurring. The focus is to emphasize the importance of individual risk factors and the need for regular re-evaluation and to create awareness of the signs and symptoms of VTE.
The prescribing physician should use current product information and treatment guidelines to select the most appropriate contraceptive for each woman.
More information: Official News (Jan. 31, 2014)
www.basg.gv.at/pharmakovigilanz/amtliche-nachrichten/amtliche-nachrichten-2014/
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: 050555/25000
E-mail: presse@ages.at
