Another New Weight-Loss Drug Approved

WEDNESDAY, July 18 (HealthDay News) — Qsymia (phentermine and
topiramate extended-release) has been approved by the U.S. Food and Drug
Administration, making it the second weight-loss drug to be given the
agency’s green light in less than a month.

In June, the agency sanctioned Belviq, the FDA‘s first diet drug
approval in some 13 years.

Qsymia is approved for adults with a body mass index (BMI) of 30 or
greater (obese) or a BMI of 27 or higher with a weight-related condition
such as high cholesterol, high blood pressure, or type 2 diabetes. BMI is
a measurement of a person’s body fat, based on their height and
weight.

Qsymia should never be used by pregnant women, the FDA warned, since it
can cause birth defects including cleft lip and cleft palate. Women of
childbearing age should have a pregnancy test before starting the drug,
the agency said.

People who do not lose at least three percent of body weight after 12
weeks of treatment are unlikely to benefit and should discontinue use, the
FDA said.

Qsymia’s safety and effectiveness were evaluated in clinical trials
involving 3,700 obese and overweight people. The most common side effects
reported included tingling of the hands and feet, dizziness, altered
taste, insomnia, constipation and dry mouth.

Drug maker Vivus Inc., based in Mountain View, Calif., is required to
conduct post-approval studies to evaluate Qsymia’s risks for major cardiac
problems, such as heart attack and stroke, the FDA said.

More information

The FDA has more about this approval.

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