FDA Reviews Safety of Diet Drug Meridia
Agency Releases Early Communication on Possible Heart Risks
WebMD News Archive
Nov. 23, 2009 -- A new study of the
weight loss drug Meridia is in the hands of FDA regulators, who've released
an early communication based on preliminary data: certain patients taking the
drug may have a higher risk of heart
attacks, strokes, and other serious cardiovascular problems.
The recent study tested Meridia (sibutramine)
in overweight or obese people
with an increased risk for heart problems. The agency warned that doctors and
their patients should follow the current guidelines, which recommend against
using Meridia in people with a history of coronary artery disease, congestive
failure, heart rhythms disorders called arrhythmias, or stroke.
The FDA will continue to review findings from the SCOUT study, which was
designed to test whether Meridia could help prevent heart problems by helping
overweight and obese people lose weight. The FDA isn't making any conclusions
about the early findings at this time. Analysis of the study's findings is
European investigators followed about 10,000 people, age 55 or older, who
had a history of heart disease or type 2 diabetes and
one additional risk factor for heart disease. Half got sibutramine along with
standard medical care for five years, while the other half took a sugar pill (a
placebo) and got standard medical care. Serious cardiovascular events occurred
- 11.4% of people taking Meridia
- 10% of patients taking a sugar pill
A spokesman for Abbott Laboratories, the maker of sibutramine, says Meridia
is safe when used in the appropriate group of people, as prescribed. According
to Kurt Ebenhoch, the SCOUT study looked at high-risk patients who took the
drug much longer than the one-year maximum use recommended in the U.S.
"Sibutramine is not recommended or approved for use in more than 90% of the
patients in the SCOUT study," Ebenhoch says.
Meridia works in the brain to help people feel full with less food. It's
approved for use by obese people with a BMI (body mass index) of 30 or
higher along with a weight loss diet and regular
exercise. It's sometimes prescribed for people with BMIs as low as 27 when they
have a weight-related condition like diabetes or sleep apnea.