Contraceptive patch and VTE warning
September 22, 2006 on 11:35 am | In Prescribing Extra - Drugs |
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The Food and Drugs Administration (FDA) has updated the labelling of the norelgestromin-ethinylestradiol contraceptive patch (Evra®) to warn patients and clinicians about the risk of venous thromboembolism (VTE).
Two epidemiological studies have examined the rates of VTE is users of the patch compared to users of oral contraceptives. One study found that rates of VTE were similar while the other study founds that rates of VTE were doubled. The FDA update carries a specific warning that patients using the patch are exposed to 60% more oestrogen despite maximum blood levels being 25% lower than equivalent oral contraceptives.
The patch available on the UK market appears to contain slightly lower levels of oestrogen however it is already recommended in the Summary of Product Characteristics that the patch is not used in patients with a history of venous thrombosis. Additionally, the Scottish Medicines Consortium has recommended that use of this patch is restricted to patients who have demonstrated, or are likely to demonstrate, poor compliance with combined oral contraceptives.
Action: Patients who may benefit from this patch due to poor compliance should be assessed for VTE risk before treatment is started.
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