Jew World Order

WEDNESDAY, June 27 (HealthDay News) — The first new weight-loss
drug in 13 years was approved Wednesday by the U.S. Food and Drug
Administration.

The drug, Belviq (lorcaserin), was approved for obese adults who have
high blood pressure, high cholesterol or type 2 diabetes, and is to be
used in combination with a low-calorie diet and exercise, the FDA
said.

“Obesity threatens the overall well-being of patients and is a major
public health concern,” Dr. Janet Woodcock, director of the FDA’s Center
for Drug Evaluation and Research, said in an agency news release. “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.”

However, Dr. David L. Katz, director of Yale University’s Prevention
Research Center, said that even the best weight-loss drugs can do little
to reverse a problem now affecting much of the population.

“Belviq is unlikely to rank among the best of drugs,” he said. “While
it is better than placebo at fostering weight loss, its effects appear to
be modest. And while trial results are reassuring so far, there are still
concerns about a potential for damage to heart valves seen with drugs of
this kind.”

Right now there is no information of the cost of the Belviq, said David
Schull, a spokesman for Arena Pharmaceuticals GmbH of Zofingen,
Switzerland, the maker of the drug. It will be distributed in the United
States by Eisai Inc., of Woodcliff Lake, N.J.

“Eisai will launch the drug after the Drug Enforcement Administration
completes its scheduling,” he said. “More information will follow as Eisai
moves toward launch.”

This isn’t the first time Belviq was up for FDA approval. In 2010,
Arena sought approval but was turned down because animal studies showed
the drug was associated with tumor growth.

New data supplied to the FDA that allayed these fears led to the drug’s
approval.

The drug works to help suppress appetite by activating an area of the
brain called the serotonin 2C receptor. The weight-loss drugs fenfluramine
and dexfenfluramine, best known as “fen-phen,” targeted a different part
of the serotonin system, and were pulled for the market because they
boosted the risk of heart valve damage.

Belviq was tested in three trials that included nearly 8,000 obese and
overweight people who were treated for a year or more. Treatment also
included dieting and exercise. Those taking Belviq for a year lost 3
percent to 3.7 percent of their weight, compared with those receiving a
placebo, the FDA said.

Forty-seven percent of people without type 2 diabetes lost at least 5
percent of their weight, compared to 23 percent of those on placebo. Among
patients with type 2 diabetes, 38 percent lost at least 5 percent of their
weight compared to 16 percent who took the dummy pill, the agency
said.

Overall, more patients taking Belviq lost weight than patients taking a
placebo, the FDA said, and the drug was also “associated with favorable
changes in glycemic [blood sugar] control in those with type 2
diabetes.”

Heart valve function was found to be similar between those taking
Belviq and those on placebo, the FDA added.

Samantha Heller, an exercise physiologist and clinical nutrition
coordinator at the Center for Cancer Care at Griffin Hospital in Derby,
Conn., said, “Obesity is often associated with alterations in endocrine
function, metabolism, hormones that regulate appetite and more.”

For many people struggling with weight, these disruptions in the
balance of hormones and metabolism make it difficult to lose weight, she
said. People may feel hungry all the time, fatigued or lethargic. Losing
weight for people who are obese is rarely as simple as eating less, she
added.

“If Belviq can actually help people begin losing weight, then it may be
a great idea. However, it is important to note that in the studies,
nutrition and exercise counseling, education and support were an integral
part of the process,” Heller said.

“People need to understand that lifestyle modifications are essential
for successful weight loss, weight maintenance, and fitness programs. The
weight loss reported in the studies is modest and the placebo group lost
weight too, indicating that ongoing lifestyle counseling and support have
a positive impact with and without medication,” she said.

There are some issues with the drug, the FDA said. First, Belviq should
be stopped if patients don’t lose at least 5 percent of their weight
within 12 weeks, since they’re unlikely to benefit from taking the drug
for any longer period of time.

Second, the drug shouldn’t be taken during pregnancy, the agency
said.

Belviq may cause serious side effects, including “serotonin syndrome,”
particularly when taken with certain medicines that increase serotonin
levels or activate serotonin receptors, such as drugs used to treat
depression and migraine. The drug may also cause problems with attention
or memory, the FDA said.

Other common side effects in non-diabetic patients include headache,
dizziness, fatigue, nausea, dry mouth, and constipation. In diabetic
patients, side effects can include low blood sugar, headache, back pain,
cough, and fatigue, the FDA said.

The agency is requiring Arena to undertake six post-marketing studies
to look for any problems with Belviq, particularly the risk for heart
attack and stroke.

Another weight loss drug, Qnexa from Vivus Inc., is still awaiting FDA
approval. An FDA advisory panel recommended approval in February.

More information

For more on obesity, visit the U.S.
National Library of Medicine.