Abbott to Suspend Marketing of Obesity Medicine Sibutramine in European Union Countries

By Abbott, PRNE
Wednesday, January 20, 2010

ABBOTT PARK, Illinois, January 21 - 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 (NYSE: ABT) 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 Raductil.

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 action.

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 recommendation."

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 prescribing information.

Patients with questions about use of the drug should contact their
physician.

Product Use

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.

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 provider.

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.

About Abbott

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.

Media, Kurt Ebenhoch, +1-847-936-9746, or Kelly Morrison, +1-847-937-3802, or Financial, John Thomas, +1-847-938-2655, or Larry Peepo, +1-847-935-6722, all of Abbott

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