Abbott Park, Illinois (ots/PRNewswire) - Today the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) voted to recommend the suspension of marketing
authorizations for all anti-obesity medicines containing sibutramine.
Abbott will comply with the CHMP recommendation and suspend the
marketing of Abbott medicines containing sibutramine in all European
Union (EU) member countries, as well as Iceland and Norway, which are
part of the European Economic Area. Abbott manufactures sibutramine
under the brand names Reductil, Meridia, Sibutral, Ectiva and
The CHMP's recommendation was based on a review of results from
the SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which
became available in November 2009.
Outside the EU, sibutramine remains available and should be used
according to the product label. The U.S. Food and Drug
Administration's (FDA) review of SCOUT is ongoing. FDA has initiated
a label change and the product remains on the market in the U.S.
Australia's Therapeutic Goods Administration (TGA) took a similar
Abbott's evaluation of the SCOUT study does not change its
assessment that sibutramine has a positive benefit/risk profile when
used appropriately in the approved patient population.
"We believe there are many patients who benefit from sibutramine
and respectfully disagree with the committee's opinion and the
recommendation to suspend the medicine," said Eugene Sun, M.D., vice
president, Global Pharmaceutical Research and Development, Abbott.
"However, we will act promptly to comply with the committee's
Sibutramine is approved for the treatment of patients who are
obese, have no previous history of cardiovascular disease and have
been unable to lose weight through diet and exercise. The
approximately 10,000 patient, six-year SCOUT study was requested by
European regulatory authorities as a post-marketing commitment to
evaluate cardiovascular safety in high-risk patients. The majority of
these patients had underlying cardiovascular disease and were
ineligible to receive sibutramine under the current labeling and
Patients with questions about use of the drug should contact
Sibutramine, along with a reduced-calorie diet and exercise, is
recommended for the management of obesity in patients with an initial
body mass index (BMI) greater than or equal to 30 kg/m2 or greater
than or equal to 27 kg/m2 in patients with other known risk factors
such as diabetes or dyslipidemia.
Important Safety Information
Sibutramine increases blood pressure or heart rate in some
patients and should not be given to patients with uncontrolled or
poorly controlled hypertension, a history of heart disease (coronary
artery disease, congestive heart failure, peripheral occlusive
arterial disease, irregular heartbeat or fast heart rate), stroke,
severe liver or kidney disease, pregnant women or nursing mothers.
Sibutramine should be used cautiously in patients with seizures. All
patients being treated with sibutramine should see their doctor as
directed for regular monitoring of blood pressure and heart rate.
Sibutramine should not be given to persons with an allergy to any
of the ingredients of sibutramine, persons with obesity due to
metabolism disorders or in individuals with a history of eating
disorders. Individuals taking monoamine oxidase inhibitors (MAOIs) or
other weight loss medications that act on the brain should not take
Sibutramine should not be taken by individuals with a mental
illness (such as manic depression). It should also not be taken by
individuals who abuse or have abused drugs, medicines or alcohol or
by people with Tourette's syndrome. Individuals with an overactive
thyroid, narrow angle glaucoma, tumors on the adrenal gland or men
with an enlarged prostate should not take sibutramine.
It is important that the health care provider is aware of all
current and past medical problems. Patients should talk to their
doctor about all medicines being taken, including those obtained
without a prescription.
Certain weight loss medicines have been associated with a rare
but life threatening condition that affects the blood pressure in
lungs (pulmonary hypertension). Because the condition is rare, it is
not known if sibutramine may cause this disease.
The most common side effects include trouble sleeping,
constipation and dry mouth. Other side effects include a fast
heartbeat, increased blood pressure, awareness of the heartbeat
(palpitations), headache, anxiety or dizziness.
This is the most important information to know about sibutramine.
For more information, patients should talk with a health care
Countries in Which Sibutramine is Being Suspended
The marketing authorization for all medicines containing
sibutramine has been suspended in: Austria, Belgium, Bulgaria, Czech
Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovak
Republic, Slovenia, Spain, Sweden and the United Kingdom.
Abbott is a global, broad-based health care company devoted to
the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals, devices
and diagnostics. The company employs more than 72,000 people and
markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
ots Originaltext: Abbott Laboratories
Im Internet recherchierbar: http://www.presseportal.ch
CONTACT: Media, Kurt Ebenhoch, +1-847-936-9746, or Kelly
Morrison,+1-847-937-3802, or Financial, John Thomas, +1-847-938-2655,
or LarryPeepo, +1-847-935-6722, all of Abbott