SILVER SPRING, Md., Oct. 8 /PRNewswire-USNewswire/ — Abbott
Laboratories has agreed to voluntarily withdraw its obesity drug
Meridia (sibutramine) from the U.S. market because of clinical
trial data indicating an increased risk of heart attack and stroke,
the U.S. Food and Drug Administration announced today.
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“Meridia’s continued availability is not justified when you
compare the very modest weight loss that people achieve on this
drug to their risk of heart attack or stroke,” said John Jenkins,
M.D., director of the Office of New Drugs in the FDA’s Center for
Drug Evaluation and Research (CDER). “Physicians are advised to
stop prescribing Meridia to their patients and patients should stop
taking this medication. Patients should talk to their health care
provider about alternative weight loss and weight loss maintenance
programs.”
Meridia was approved by the FDA in November 1997 for weight loss
and maintenance of weight loss in obese people, as well as in
certain overweight people with other risks for heart disease. The
approval was based on clinical data showing that more people
receiving sibutramine lost at least 5 percent of their body weight
than people on placebo who relied on diet and exercise alone.
The FDA requested the market withdrawal after reviewing data
from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT
was initiated as part of a postmarket requirement to look at
cardiovascular safety of sibutramine after the European approval of
this drug. The trial demonstrated a 16 percent increase in
the risk of serious heart events, including non-fatal heart attack,
non-fatal stroke, the need to be resuscitated once the heart
stopped, and death, in a group o
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