EVRA linked to VTE
January 24, 2008 on 10:15 am | In Prescribing Extra - Drugs |
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The Food and Drugs Administration has updated prescribing information for the contraceptive patch (EVRA®) after studies found an increased risk of venous thromboembolism (VTE) when compared to combined oral contraceptive tablets (COCs).
According to information on the manufacturers website there have been four epidemiological studies comparing the patch to oral contraceptives. Two of these studies found no difference in risk while two have found an approximate doubling of risk.
The Summary of Product Characteristics (SPC) available in the UK states that, “currently there is no evidence to exclude that EVRA may be more thrombogenic than combined oral contraceptives“. The SPC also states that this product should not be used in patients with a history of venous thromboembolism.
Action: When discussing contraceptive options, clinicians should ensure that patients are made aware of the increased risk of VTE with EVRA compared to COCs.
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