Diane 35 safety concerns BY: MOHAMMED ALSAIDAN. Background Diane-35 contains Ethinylestradiol (35...
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Transcript of Diane 35 safety concerns BY: MOHAMMED ALSAIDAN. Background Diane-35 contains Ethinylestradiol (35...
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Diane 35 safety concerns
BY: MOHAMMED ALSAIDAN
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Background
• Diane-35 contains • Ethinylestradiol (35 μg)• cyproterone acetate (2mg)
• Yasmin :• Ethinylestradiol (30 μg)• drospirenone (3 mg)
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Background
• Cases of venous thromboembolism were first reported in the 1960s in women taking combination OCP
• Low-estrogen preparations are associated with lower rates of venous thrombosis.
• “third-generation progestagens” (e.g., desogestrel) are associated with about double the risk of venous thrombosis of either the first- (norethindrone) or second- generation (levonorgestrel) progestagens, although the association is controversial
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Background
• Venous thrombosis develops usually within the first year after starting the drug
• Oral contraceptives users at increased risk of venous thromboembolism include those who are • Obese• prothrombotic mutations (factor V Leiden carriers ) • Injury• Immobility• postoperative status• postpartum status
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Indications
• Diane-35 is approved only as therapy for androgen-sensitive skin conditions, including • hirsutism • severe acne unresponsive to oral antibiotic therapy
• seborrhea • FPHL • OCP !• Decrease uric acid level in obese patient with PCOs• Pretreatment to improve the outcome of ovulation induction
by clompiphene
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Background
• Diane-35 should be discontinued 3–4 menstrual cycles after a woman’s skin condition has resolved.
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Recommendation
• Diane-35 should be reserved for temporary use in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism, in women of reproductive age, when alternative treatments such as topical therapy (applied to the skin) or antibiotics have failed and should not be used solely as an oral contraceptive
• All women taking combination OCP should be informed of this rare but potentially serious adverse effect, particularly if they are taking Diane- 35.
• Clearly caution, and not panic, is warranted.
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Recommendation
• Switching 2220 women from Diane-35 to an oral levonorgestrel contraceptive for 1 year would prevent 1 case of nonfatal venous thromboembolism.
• Consider not prescribing Diane-35 for women at risk of venous thromboembolism (especially those who carry prothrombotic mutations),
• Most venous thrombotic events are truly idiopathic (i.e. the women have no clinically recognizable risk factors).
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Recommendation
• The risk of VTE with these medicines is 1.5 to 2 times higher than for COCs containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
• Furthermore the PRAC concluded that in the treatment of alopecia the benefits did not outweigh the risks.
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Recommendation
• Concomitant use with another hormonal contraceptive would expose the woman to a higher dose of oestrogen and increase her risk of VTE.
• To raise the awareness amongst healthcare professionals and patients of the risk of thromboembolism,
• the company should carry out a study on the use of Diane 35 as well as a study on the effectiveness of the recommended risk minimisation measures.
• The next meeting of 27 to 29 May 2013. The CMDh will adopt a final decision
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Thank you
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