Press Release

ABBOTT PARK, Illinois, January 21 /PRNewswire/ -- Today the Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) voted to recommend the suspension ofmarketing authorizations for all anti-obesity medicines containingsibutramine. Abbott (NYSE: ABT) will comply with the CHMP recommendation andsuspend the marketing of Abbott medicines containing sibutramine in allEuropean Union (EU) member countries, as well as Iceland and Norway, whichare part of the European Economic Area. Abbott manufactures sibutramine underthe brand names Reductil, Meridia, Sibutral, Ectiva and Raductil.

The CHMP's recommendation was based on a review of results from the SCOUTstudy (Sibutramine Cardiovascular OUTcome Trial), which became available inNovember 2009.

Outside the EU, sibutramine remains available and should be usedaccording 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 productremains on the market in the U.S. Australia's Therapeutic GoodsAdministration (TGA) took a similar action.

Abbott's evaluation of the SCOUT study does not change its assessmentthat sibutramine has a positive benefit/risk profile when used appropriatelyin the approved patient population.

"We believe there are many patients who benefit from sibutramine andrespectfully disagree with the committee's opinion and the recommendation tosuspend the medicine," said Eugene Sun, M.D., vice president, GlobalPharmaceutical Research and Development, Abbott. "However, we will actpromptly to comply with the committee's recommendation."

Sibutramine is approved for the treatment of patients who are obese, haveno previous history of cardiovascular disease and have been unable to loseweight through diet and exercise. The approximately 10,000 patient, six-yearSCOUT study was requested by European regulatory authorities as apost-marketing commitment to evaluate cardiovascular safety in high-riskpatients. The majority of these patients had underlying cardiovasculardisease and were ineligible to receive sibutramine under the current labelingand prescribing information.

Patients with questions about use of the drug should contact theirphysician.

Product Use

Sibutramine, along with a reduced-calorie diet and exercise, isrecommended for the management of obesity in patients with an initial bodymass index (BMI) greater than or equal to 30 kg/m2 or greater than or equalto 27 kg/m2 in patients with other known risk factors such as diabetes ordyslipidemia.

Important Safety Information

Sibutramine increases blood pressure or heart rate in some patients andshould not be given to patients with uncontrolled or poorly controlledhypertension, a history of heart disease (coronary artery disease, congestiveheart failure, peripheral occlusive arterial disease, irregular heartbeat orfast heart rate), stroke, severe liver or kidney disease, pregnant women ornursing mothers. Sibutramine should be used cautiously in patients withseizures. All patients being treated with sibutramine should see their doctoras directed for regular monitoring of blood pressure and heart rate.

Sibutramine should not be given to persons with an allergy to any of theingredients of sibutramine, persons with obesity due to metabolism disordersor in individuals with a history of eating disorders. Individuals takingmonoamine oxidase inhibitors (MAOIs) or other weight loss medications thatact 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 whoabuse or have abused drugs, medicines or alcohol or by people with Tourette'ssyndrome. Individuals with an overactive thyroid, narrow angle glaucoma,tumors on the adrenal gland or men with an enlarged prostate should not takesibutramine.

It is important that the health care provider is aware of all current andpast medical problems. Patients should talk to their doctor about allmedicines being taken, including those obtained without a prescription.

Certain weight loss medicines have been associated with a rare but lifethreatening condition that affects the blood pressure in lungs (pulmonaryhypertension). Because the condition is rare, it is not known if sibutraminemay cause this disease.

The most common side effects include trouble sleeping, constipation anddry mouth. Other side effects include a fast heartbeat, increased bloodpressure, awareness of the heartbeat (palpitations), headache, anxiety ordizziness.

This is the most important information to know about sibutramine. Formore information, patients should talk with a health care provider.

Countries in Which Sibutramine is Being Suspended

The marketing authorization for all medicines containing sibutramine hasbeen 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, Swedenand the United Kingdom.

About Abbott

Abbott is a global, broad-based health care company devoted to thediscovery, development, manufacture and marketing of pharmaceuticals andmedical products, including nutritionals, devices and diagnostics. Thecompany employs more than 72,000 people and markets its products in more than130 countries.

Abbott's news releases and other information are available on thecompany's Web site at www.abbott.com.