ORAL CONTRACEPTIVE PILL UNDER TGA REVIEW

March 4, 2013 by  
Filed under Health Blog

THE TGA is undertaking a safety review of the drug Diane-35 and its generics following an announcement that France will soon suspend its marketing authorisation.

Diane-35, an anti-androgenic progestogen-oestrogen combination, is approved for treating androgenisation in women including severe acne and hirsutism. It is also an effective oral contraceptive in these patients although the TGA stressed it was not approved for this indication in Australia.

The French authorities (ANSM) found the risk of venous thromboembolism (VTE) outweighed the benefits of Diane-35 and have announced it will be suspended within the next three months.

The European Medicines Agency is also planning a broad review of third- and fourth-generation oral contraceptive pills (OCPs) following reports of four deaths related to the drug.

“Health professionals should weigh the clinical needs of their patients against the possible slight increase in the risk of VTE, should inform their patients about the increased risk of VTE and educate their patients to recognise the signs and symptoms of VTE,” the TGA said in a post on its website.

Diane-35 is also available in Australia under the trade names Brenda-35, Juliet-35, Estelle-35 and Laila-35.

Manufacturer Bayer has said the risk of VTE was known and clearly mentioned on the product label. 

Yours In Great Health,
Sar Rooney BHSc., ND., DC., DASc., GDSc. (Hons), MATMS, MNHAA, MHATO
Naturopathic Medicine Practitioner, Lecturer, Researcher

 
Earth Medicine TM
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