|Back||Reported Adverse Drug Reaction Cases|
|Venous thromboembolism with third generation oral contraceptives and cyproterone|
Third generation oral contraceptives
Venous thromboembolism (VTE) is a recognised complication of oral contraceptives. For a number of years it has been debated whether "third generation" (containing desogestrel or gestodene) combined oral contraceptive pills (OCP) carry a higher risk of VTE than "second generation" OCP (containing levonorgestrel or norethist-erone). A number of independent studies addressing the issue have been published.1,2 The European Agency for the Evaluation of Medicinal Products (EMEA) released its final position statement in September 2001 which indicates a "small increased risk of venous thrombo-embolism" with OCPs containing desogestrel or gestodene compared with second generation OCPs.3 The overall conclusions of both the EMEA and an earlier statement from New Zealand Medsafe in 1996 4 are as follows:
Third generation OCPs marketed in Australia are shown in Table 2. These products are not extensively used in Australia.
New Zealand Medsafe has also released a statement concerning oral contraceptives containing cyproterone.6 The conclusion of its review is that:
In Australia, products containing low dose cyproterone (2 mg) combined with ethinyloestradiol (see Table 2) are not indicated for contraception but for treatment of signs of androgenisation in women. These include severe acne where prolonged oral antibiotics or local treatment alone has not been successful, and idiopathic hirsutism of mild to moderate degree. These products will also provide effective oral contraception in this patient group but they are not available on the PBS.
ADRAC suggests that all women being prescribed combined oral contraceptives or combined cyproterone products should be advised of the benefits and risks. Each woman should be assessed carefully for inherent or pre-existing risk factors, including family history. For cyproterone, the indications for use should be followed.
» Latest Notification
» New Drugs
» Import of Drugs
» Drug Prices
|» Applications Forms
» Forms & Fees
» Licence Conditions
» Health, Pharma. Policies & Reports
» Govt. Bodies
» Information Centre
|» Regulatory News
» Research News
» News in Hindi
» Contact Us
DrugsControl.org - Jaipur, INDIA. All Rights Reserved |
||Site last updated: December 30, 1899 at|