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 bureau 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 early 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 bureau 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 country concerns,
according to the AP.
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 team
said.
However, the regimen did come with side effects, and about half of
study participants dropped out before completing a year of treatment.
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 fat or
overweightm, with high blood fat levels or high blood pressure.
The participants were told to take 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. Nearly 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 might give people struggling to lose weight a new option,
the researchers contended.
The Lancet findings reflexion those of studies into other diet drugs
such as Meridia, Xenical and Alli, stated Lona Sandon, an assistant
professor of clinical nutrition at the University of Texas Southwestern
Medical Center in metropolis 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 might 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.”
An accompanying 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 superior 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.
More information

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