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by Robert MacKay, Thursday, October 9, 2014 | Categories: Contrave

Contrave has been approved for prescription in the United States. While this is great news for overweight patients in the US who struggle to lose weight through exercise and calorie restriction, it remains to be seen whether this product will get the green light in the EU. Contrave is currently being considered by the European Medicines Agency and we expect a decision before the end of 2014. We are aware that the EMA has recently requested more information on the risks versus outcomes. This is not unusual and should  not be taken as a negative signal.

The medication has been approved by the FDA with a number of provisos. First of all, an extensive post marketing study is required on the cardiovascular outcomes. Initial results of the Light Study trial have previously been reported here and those were favourable. However, it has been noted that blood pressure and heart rate can increase while taking Contrave so a much longer term study is required to ensure that seriously detrimental cardiovascular side effects are not observed. A further study on the effect that Contrave has on cardio conduction has also been ordered, as well as drug interaction studies.

Contrave has the potential to cause suicidal thought and other psychiatric side effects. Clinicians will need to be vigilant for any side effects and will need to screen out patients who may be prone to these side effects. Blood pressure must be monitored on a regular basis and patients with uncontrolled high blood pressure would be unsuitable candidates. Anyone who has not lost at least 5% of bodyweight within 3 months should discontinue the medication as the risks associated with the medication may outweigh any potential benefit.

We desperately need more options within our pharmaceutical armamentarium for talking obesity and the addition of Contrave would be helpful, even if it is definitely not suitable for many people.

You can read more information about the FDA approval of Contrave here.





 
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