New Diet Drug Lorcaserin Wins Vote From FDA Panel
Panelists Still Cite Need for Continued Research on Heart Valve Risk
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'Lingering Uncertainty' continued...
In addition, "there is still a lingering uncertainty" about the connection between lorcaserin and heart valve disease, said panelist Sanjay Kaul, MD, a UCLA cardiology professor who voted against approving the drug. ''Given the totality of evidence, the potential benefits of [the drug] do not outweigh the potential risks."
Doctors who spoke in the public hearing emphasized the need for additional treatment methods for obesity other than diet and exercise on one hand and surgery on the other.
''We need a broader spectrum of tools -- something between cutting calories and cutting the GI tract," said Domenica Rubino, MD, an obesity specialist from Arlington, Va.
Risks of Untreated Obesity
And the doctors noted that untreated obesity carries its own risks.
"There can be no doubt. Untreated obesity harms every body system," said Northwestern University obesity specialist Robert Kushner, MD, representing the Obesity Society, of which Arena is a corporate member.
Lisa Sutter of the Washington, D.C., area told committee members that she had participated in a phase II trial of lorcaserin from 2007 to 2009.
"It was amazing," said Sutter. "My brain switched back to normal again."
In a year, she said, she lost 40 pounds, about 20% of her starting weight. But for the second year of the study, she was taken off the drug. "So now I'm back to where I was, and more," she said.
The FDA is expected to make a decision about lorcaserin by June 27.