New Diet Pill Wins FDA Panel's Backing12/08/10
TUESDAY, Dec. 7 (HealthDay News) -- An expert advisory panel
recommended on Tuesday that Contrave, a new weight-loss pill that
combines an antidepressant with an anti-addiction medication, be
approved by the U.S. Food and Drug Administration.
The 13-7 vote in favor of Contrave came amid agency concerns
that the drug might raise blood pressure in some patients and
increase the risk of heart attacks and strokes among some users,
according to the
Associated Press. But panelists voted 11-8 earlier in the day that those potential health risks could be studied after Contrave was approved.
The FDA does not have to follow the advice of its advisory
committees, but it typically does. The agency is expected to make a
decision on Contrave by Jan. 31, the wire service reported.
Contrave is manufactured by Orexigen Therapeutics Inc. In
October, the FDA voted against approving two other weight-loss
drugs, Arena Pharmaceuticals' lorcaserin and Vivus' Qnexa, because
of safety concerns, according to the
Last July, a study funded by Orexigen and published in
The Lancet found that Contrave helped users shed pounds when
taken along with a healthy diet and exercise.
People who took the drug for more than a year lost an average of
5 percent or more of body weight, depending on the dose used, the
However, the regimen did come with side effects, and about half
of study participants dropped out before completing a year of
Contrave is combination of two well-known drugs, naltrexone
(Revia, used to fight addictions) and the antidepressant bupropion
(known by a number of names, including Wellbutrin). The drug
appears to boost weight loss by changing the workings of the body's
central nervous system, the researchers said.
The study enrolled men (15 percent) and women (85 percent) from
around the country, ranging in age from 18 to 65. They were all
either obese or overweightm, with high blood fat levels or high
The participants were told to eat less and exercise, and they
were randomly assigned to take a twice-daily placebo or a
combination of the two drugs at one of two levels.
After 56 weeks, only about half (870) of the more than 1,700
participants initially enrolled remained in the study. Almost half
(48 percent) of those who took the highest dose of naltrexone lost
5 percent of their weight or more, while only 16 percent of those
who took placebos did.
However, about 30 percent of those taking Contrave experienced
nausea, the study authors say, and other side effects included
headache, constipation, dizziness, vomiting and dry mouth.
Still, Contrave may give people struggling to lose weight a new
option, the researchers contended.
Lancet findings echo those of studies into other diet drugs
such as Meridia, Xenical and Alli, said Lona Sandon, an assistant
professor of clinical nutrition at the University of Texas
Southwestern Medical Center in Dallas and spokeswoman for the
American Dietetic Association.
"When these are combined with a modestly reduced calorie diet, modest amounts of weight loss are achieved," she said. "One striking thing to note is the study drop-out rate of 50 percent. This may have been due to side effects of medications, the fact that it is hard to stick to dietary changes for 56 weeks, or [the fact that] slow and only modest weight loss did not meet participant expectations."
Cynthia Sass, a New York City-based nutritionist and author,
added that drugs used to treat addiction also appear to help with
weight control, supporting "the notion that food can be addictive
for many people."
Lancet editorial noted that one concern is that blood
pressure did not drop as much as expected in the higher weight-loss
group. "More data are needed to get a better overall assessment of
cardiovascular risk of this otherwise promising combination therapy
for obesity," wrote Professor Arne Astrup, a nutrition expert at
the University of Copenhagen, Denmark.
For more about
weight loss, visit the U.S. National Library of Medicine.
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