Evra: myocardial infarction and thromboembolic events

Evra is a transdermal hormonal contraceptive system containing 6 mg of Norelgestromin and 0.6 mg of Ethinyl Estradiol per patch.

Since its introduction on the Canadian market in early 2004, 16 cases of thromboembolism and 1 of myocardial infarction suspected of being associated with the product have been reported to Health Canada. Two of the 17 patients died.

Hormonal contraception is one of the known risk factors for venous thromboembolism ( VTE ). Others include prolonged immobility, major surgery, family history of VTE, increasing age, smoking and obesity ( body mass index [ BMI ] = 30 kg/m2 ).

The risks may be cumulative if more than one risk factor is present.

An association between overweight ( BMI = 25 < 30 kg/m2 ) and thrombosis has also been observed among women using oral contraceptives.
The combined effect of obesity or overweight and oral contraceptive use was greater than the expected risks based on their individual effects.

The risk of VTE is also reported to be higher during the first 3 postpartum months than during pregnancy.
The product monograph states that women should be encouraged to use a nonhormonal form of contraception in the 3 months following delivery.

Source: Health Canada, 2008


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