For the first time in 13 years a weight-loss pill has been approved by US health regulators.
Named Belviq (photo, from bbc.co.uk) this pill can be used by obese or overweight adults with at least one condition.
In clinical studies, this drug made by Arena Pharmaceutical achieved only modest results by helping people lose on average about 5% of their body weight.
It was first rejected in 2010, due to concerns over tumours that developed in animals tested with Belviq.
But when the San Diego-based Arena resubmitted its application with more data, the US FDA found little risk of tumours in humans using the drug.
However the US Food and Drug Administration (FDA) warned that Belviq is not for women who are pregnant or nursing.
The pill is expected to launch in 2013.
Side effects
Designed to block appetite signals in the brain, Belviq would make patients feel fuller with smaller amounts of food.
The pill has been approved for use in obese adults with a body mass index (BMI) of 30 or greater, and it can also be used by overweight adults with BMI of 27 or greater who have at least one other condition like high blood pressure, type 2 diabetes or high cholesterol.
Many doctors have urged health regulators to give the green light to new weight-loss treatments, as US obesity rates are approaching 35% in adults and associated healthcare costs are on the rise.
However the standards are set high by the agency for such medication, following safety problems with weight-loss drugs that were previously popular.
In 1997 the so-called fen-phen combination had to be pulled from the market after it was linked to heart valve damage.
Belviq does not appear to carry the same risks, said the FDA in a statement.
But this drug also has side effects, which include depression, migraine and memory lapses.
According to the FDA-approved label, Belviq should not be used for more than 12 weeks if a 5% weight loss does not occur.
And after marketing the drug, Arena will be required to conduct six studies, including a study on the drug’s effect on long-term heart health.
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