By: Matthew Perrone | Associated Press, NBC-17 Published: June 27, 2012 Updated: June 27, 2012 - 4:36 PM
The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weightloss to enter the U.S. market in over a decade.
Despite only achieving modest weightloss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Dr. Ronald Sha, medical director at Duke Diet and Fitness Center, said the FDA sets the bar high, which should hopefully mean the drug is safe.
The FDA realizes that as soon as theres a weight loss medicine approved, two-thirds of American adults are going to want to take it and the FDA realizes that if only a tiny fraction of a percentage of people have side effects, thats thousands of people who have side effects," he said
Still, he's not ready to prescribe it. He wants to wait a few months after it's on the market before allowing his patients to take it.
"There have been a large number of weight loss medicines approved in this country that have subsequently been taken off the market after theyve been found to have unpleasant side effects, so I think itd be wise to just wait and see if its completely safe," he said.
"The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition," said FDA's drug center director, Dr. Janet Woodcock, in a statement.
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Dr. Ronald Sha comments: FDA clears first new weight-loss pill in 13 years
