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.