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 Raductil.

The CHMPs 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 Administrations (FDA) review of SCOUT is ongoing. FDA has initiated a label change and the product remains on the market in the U.S. Australias Therapeutic Goods Administration (TGA) took a similar action.

 

Abbotts 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 committees 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 committees 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 Tourettes 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.

Abbotts news releases and other information are available on the companys Web site at http://www.abbott.com .

AllBusiness.com, Inc

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Obesity can be treated by dieting and exercise programs, or by the use of drugs and surgery. The best way to figure out which one is best for you is to consult a doctor who will have a good idea of what type of diet or weight loss program will best suit your specific condition. A qualified doctor?s prescription is much safer and effective than what you usually find in diet magazines. As an added advantage, you can have your condition monitored by the doctor who can take you off of treatments that do not seem to be working. If your obesity is the result of hormone imbalance, an endocrinologist’s advice is called for.

Simultaneous exercise with dieting often works well. Here also, it is better to consult your doctor to learn which forms of exercise may be more useful for you. But be sure that you can handle the exercise you have been recommended to do. If overeating is your problem, try to resist the temptation by following suitable methods and say ?no? to food when necessary. Consult a psychiatrist if your eating problems are more psychological than physical.

Drugs for weight loss fall into several categories; appetite-changing drugs like Sibutramine, metabolism-changing drugs like Orlistat, and energy-boosting drugs like Ephedrine. A doctor must be consulted before you use any of them because they might produce serious side-effects if taken arbitrarily.

Two types of surgery have been recommended to treat people having severe obesity. The first one is gastroplasty, which surgically reduces the size of the stomach and gastric bypass surgery that creates a small stomach pouch and connects this pouch to the second portion of the intestines. Liposuction is no more than just a cosmetic method that removes fat cells at certain points of the body.