Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
3 mg drospirenone/30 microgram ethinyloestradiol 28 tablets (21 active tablets packaged with 7 placebo tablets)
Approved indication: contraception
Australian Medicines Handbook section 17.1.3
Drospirenone is a new progestogen. It has actions which are similar to those of progesterone.
A fixed combination of drospirenone and ethinyloestradiol is contraceptive. It has been studied in several open trials including a comparison with the combination of ethinyloestradiol 30 microgram and desogestrel 150 microgram(Marvelon). A total of 627 women took one of the pills for 26 cycles. There were three pregnancies with each drug. The incidence of breakthrough bleeding and dysmenorrhea was the same for both pills. Approximately 21% of women will have spotting during the first six cycles of treatment with drospirenone/ethinyloestradiol. Adverse events prompted 11% of the women to withdraw from the study.1
The contraindications and precautions for the combination resemble those of other combined pills. Common adverse events include headache, breast pain and nausea.
Drospirenone has been claimed to have antiandrogenic and antimineralocorticoid properties, but the clinical significance of these effects is uncertain. In the comparative study women taking the pill containing drospirenone did not put on as much weight. After two years of treatment mean weight gain was 0.4kg compared to 0.98 kg with the desogestrel-containing pill. There was no significant difference in the incidence of premenstrual symptoms.1
- Foidart J-M, Wuttke W, Bouw GM, Gerlinger C, Heithecker R. A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. Eur J Contracept Reprod Health Care 2000;5:124-34.