Sibutramine - Ireland
The European Medicines Agency (EMA) has recommended that all medicines containing the drug sibutramine should no longer be prescribed or dispensed in European Union (EU) member countries, as well as Iceland and Norway. The Irish Medicines Board in accordance with the EMA's recommendations, has suspended the marketing authorisations for all sibutramine containing products in Ireland. Arising from this suspension, the Irish Medicines Board are advising that all sibutramine containing medicines are recalled at pharmacy level. Abbott is complying with the agency's recommendation.
Abbott markets sibutramine medicine under the brand name of Reductil in Ireland. Sibutramine is also marketed in Ireland under other names by other companies.
Below you will find answers to some of the most frequently asked questions about the EMA recommendation and sibutramine. For additional information, please consult your physician.
The Irish Medicines Board (IMB) was a national participant in a decision making process at European level, which concluded that the benefits of sibutramine medicines no longer outweigh its risks. In the interest of patient safety, the recommendation is that the marketing authorisations for sibutramine-containing medicines should be suspended across the European Union.
Abbott will comply with that decision and are acting promptly to cease sales, marketing and distribution of Abbott Sibutramine products (brand name Reductil).
What is sibutramine?
- Sibutramine is a treatment for patients who are obese, have no previous history of cardiovascular disease and have been unable to lose weight through diet and exercise.
- It is the active pharmaceutical ingredient in some medicines, including the Abbott-branded medicine Reductil.
- It acts centrally in the brain where the body's signal for hunger occurs. It reduces food intake by increasing patients' feeling of fullness.
- Sibutramine is not an appetite suppressant. Appetite suppressants suppress the appetite signal so patients do not begin eating.
Was sibutramine suspended in Europe?
- The Committee for Medicinal Products for Human Use (CHMP) of the EMA voted to recommend the suspension of marketing authorisations for all medicines containing sibutramine in the EU, as well as Iceland and Norway.
- 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.
- Abbott’s evaluation of the SCOUT study data does not change its assessment that sibutramine has a positive benefit/risk profile when used appropriately in the approved patient population.
How do I know whether my medicine contains sibutramine?
- Patients who are currently being treated with sibutramine should discontinue treatment and be advised to make an appointment with their doctor at a convenient time to discuss alternative measures to lose weight, including use of diet and exercise regimes.
What is the SCOUT study?
- The approximately 10,000 patient SCOUT study was requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients with a history of cardiovascular disease, and did not directly assess the risk/benefit profile of the drug in patients from whom it is specifically intended. The majority of the patients in the study (more than 90 percent) had underlying cardiovascular disease and were ineligible to receive sibutramine under the current labeling and prescribing information.
Was sibutramine suspended in countries outside the EU and Iceland and Norway?
- In most countries outside the EU, sibutramine remains available and should be used according to the product label.
Where did the EMA suspend sibutramine?
- The countries in the European Union, as well as Iceland and Norway. These countries include: 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.
If my physician instructs me to stop taking sibutramine, what should I do with my remaining sibutramine tablets?
- Please return your supply of sibutramine to the original location of purchase.
Can I replace my sibutramine with a different prescription?
- Only you and your physician can determine what weight reduction treatment options best suit individual patient needs.
Is there a telephone number or e-mail address where I can send my questions?
- Please speak directly to your physician or pharmacist if you have any queries.
What are the side effects associated with sibutramine?
- Most common side effects include trouble sleeping, constipation and dry mouth. Other side effects include nausea, increased blood pressure, heart palpitations, headache, anxiety, sweating or dizziness.
ABBOTT PARK, Ill., Jan. 21, 2010 – 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 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.
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.
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.
For further information please visit the Irish Medicines Board website at www.imb.ie