Magazin
2010-01-21
Abbott Park, Illinois (ots/PRNewswire) - Today the Committeefor Medicinal Products for Human Use (CHMP) of the European MedicinesAgency (EMA) voted to recommend the suspension of marketingauthorizations for all anti-obesity medicines containing sibutramine.Abbott will comply with the CHMP recommendation and suspend themarketing of Abbott medicines containing sibutramine in all EuropeanUnion (EU) member countries, as well as Iceland and Norway, which arepart of the European Economic Area. Abbott manufactures sibutramineunder the brand names Reductil, Meridia, Sibutral, Ectiva andRaductil.
The CHMP's recommendation was based on a review of results fromthe SCOUT study (Sibutramine Cardiovascular OUTcome Trial), whichbecame available in November 2009.
Outside the EU, sibutramine remains available and should be usedaccording to the product label. The U.S. Food and DrugAdministration's (FDA) review of SCOUT is ongoing. FDA has initiateda label change and the product remains on the market in the U.S.Australia's Therapeutic Goods Administration (TGA) took a similaraction.
Abbott's evaluation of the SCOUT study does not change itsassessment that sibutramine has a positive benefit/risk profile whenused appropriately in the approved patient population.
"We believe there are many patients who benefit from sibutramineand respectfully disagree with the committee's opinion and therecommendation to suspend the medicine," said Eugene Sun, M.D., vicepresident, Global Pharmaceutical Research and Development, Abbott."However, we will act promptly to comply with the committee'srecommendation."
Sibutramine is approved for the treatment of patients who areobese, have no previous history of cardiovascular disease and havebeen unable to lose weight through diet and exercise. Theapproximately 10,000 patient, six-year SCOUT study was requested byEuropean regulatory authorities as a post-marketing commitment toevaluate cardiovascular safety in high-risk patients. The majority ofthese patients had underlying cardiovascular disease and wereineligible to receive sibutramine under the current labeling andprescribing information.
Patients with questions about use of the drug should contacttheir physician.
Product Use
Sibutramine, along with a reduced-calorie diet and exercise, isrecommended for the management of obesity in patients with an initialbody mass index (BMI) greater than or equal to 30 kg/m2 or greaterthan or equal to 27 kg/m2 in patients with other known risk factorssuch as diabetes or dyslipidemia.
Important Safety Information
Sibutramine increases blood pressure or heart rate in somepatients and should not be given to patients with uncontrolled orpoorly controlled hypertension, a history of heart disease (coronaryartery disease, congestive heart failure, peripheral occlusivearterial 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. Allpatients being treated with sibutramine should see their doctor asdirected for regular monitoring of blood pressure and heart rate.
Sibutramine should not be given to persons with an allergy to anyof the ingredients of sibutramine, persons with obesity due tometabolism disorders or in individuals with a history of eatingdisorders. Individuals taking monoamine oxidase inhibitors (MAOIs) orother weight loss medications that act on the brain should not takesibutramine.
Sibutramine should not be taken by individuals with a mentalillness (such as manic depression). It should also not be taken byindividuals who abuse or have abused drugs, medicines or alcohol orby people with Tourette's syndrome. Individuals with an overactivethyroid, narrow angle glaucoma, tumors on the adrenal gland or menwith an enlarged prostate should not take sibutramine.
It is important that the health care provider is aware of allcurrent and past medical problems. Patients should talk to theirdoctor about all medicines being taken, including those obtainedwithout a prescription.
Certain weight loss medicines have been associated with a rarebut life threatening condition that affects the blood pressure inlungs (pulmonary hypertension). Because the condition is rare, it isnot known if sibutramine may cause this disease.
The most common side effects include trouble sleeping,constipation and dry mouth. Other side effects include a fastheartbeat, 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 careprovider.
Countries in Which Sibutramine is Being Suspended
The marketing authorization for all medicines containingsibutramine has been suspended in: Austria, Belgium, Bulgaria, CzechRepublic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,Malta, the Netherlands, Norway, Poland, Portugal, Romania, SlovakRepublic, Slovenia, Spain, Sweden and the United Kingdom.
About Abbott
Abbott is a global, broad-based health care company devoted tothe discovery, development, manufacture and marketing ofpharmaceuticals and medical products, including nutritionals, devicesand diagnostics. The company employs more than 72,000 people andmarkets its products in more than 130 countries.
Abbott's news releases and other information are available on thecompany's Web site at www.abbott.com.
ots Originaltext: Abbott LaboratoriesIm Internet recherchierbar: http://www.presseportal.de
Contact: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
Abbott to Suspend Marketing of Obesity Medicine Sibutramine in European Union Countries
Abbott Park, Illinois (ots/PRNewswire) - Today the Committeefor Medicinal Products for Human Use (CHMP) of the European MedicinesAgency (EMA) voted to recommend the suspension of marketingauthorizations for all anti-obesity medicines containing sibutramine.Abbott will comply with the CHMP recommendation and suspend themarketing of Abbott medicines containing sibutramine in all EuropeanUnion (EU) member countries, as well as Iceland and Norway, which arepart of the European Economic Area. Abbott manufactures sibutramineunder the brand names Reductil, Meridia, Sibutral, Ectiva andRaductil.
The CHMP's recommendation was based on a review of results fromthe SCOUT study (Sibutramine Cardiovascular OUTcome Trial), whichbecame available in November 2009.
Outside the EU, sibutramine remains available and should be usedaccording to the product label. The U.S. Food and DrugAdministration's (FDA) review of SCOUT is ongoing. FDA has initiateda label change and the product remains on the market in the U.S.Australia's Therapeutic Goods Administration (TGA) took a similaraction.
Abbott's evaluation of the SCOUT study does not change itsassessment that sibutramine has a positive benefit/risk profile whenused appropriately in the approved patient population.
"We believe there are many patients who benefit from sibutramineand respectfully disagree with the committee's opinion and therecommendation to suspend the medicine," said Eugene Sun, M.D., vicepresident, Global Pharmaceutical Research and Development, Abbott."However, we will act promptly to comply with the committee'srecommendation."
Sibutramine is approved for the treatment of patients who areobese, have no previous history of cardiovascular disease and havebeen unable to lose weight through diet and exercise. Theapproximately 10,000 patient, six-year SCOUT study was requested byEuropean regulatory authorities as a post-marketing commitment toevaluate cardiovascular safety in high-risk patients. The majority ofthese patients had underlying cardiovascular disease and wereineligible to receive sibutramine under the current labeling andprescribing information.
Patients with questions about use of the drug should contacttheir physician.
Product Use
Sibutramine, along with a reduced-calorie diet and exercise, isrecommended for the management of obesity in patients with an initialbody mass index (BMI) greater than or equal to 30 kg/m2 or greaterthan or equal to 27 kg/m2 in patients with other known risk factorssuch as diabetes or dyslipidemia.
Important Safety Information
Sibutramine increases blood pressure or heart rate in somepatients and should not be given to patients with uncontrolled orpoorly controlled hypertension, a history of heart disease (coronaryartery disease, congestive heart failure, peripheral occlusivearterial 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. Allpatients being treated with sibutramine should see their doctor asdirected for regular monitoring of blood pressure and heart rate.
Sibutramine should not be given to persons with an allergy to anyof the ingredients of sibutramine, persons with obesity due tometabolism disorders or in individuals with a history of eatingdisorders. Individuals taking monoamine oxidase inhibitors (MAOIs) orother weight loss medications that act on the brain should not takesibutramine.
Sibutramine should not be taken by individuals with a mentalillness (such as manic depression). It should also not be taken byindividuals who abuse or have abused drugs, medicines or alcohol orby people with Tourette's syndrome. Individuals with an overactivethyroid, narrow angle glaucoma, tumors on the adrenal gland or menwith an enlarged prostate should not take sibutramine.
It is important that the health care provider is aware of allcurrent and past medical problems. Patients should talk to theirdoctor about all medicines being taken, including those obtainedwithout a prescription.
Certain weight loss medicines have been associated with a rarebut life threatening condition that affects the blood pressure inlungs (pulmonary hypertension). Because the condition is rare, it isnot known if sibutramine may cause this disease.
The most common side effects include trouble sleeping,constipation and dry mouth. Other side effects include a fastheartbeat, 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 careprovider.
Countries in Which Sibutramine is Being Suspended
The marketing authorization for all medicines containingsibutramine has been suspended in: Austria, Belgium, Bulgaria, CzechRepublic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,Malta, the Netherlands, Norway, Poland, Portugal, Romania, SlovakRepublic, Slovenia, Spain, Sweden and the United Kingdom.
About Abbott
Abbott is a global, broad-based health care company devoted tothe discovery, development, manufacture and marketing ofpharmaceuticals and medical products, including nutritionals, devicesand diagnostics. The company employs more than 72,000 people andmarkets its products in more than 130 countries.
Abbott's news releases and other information are available on thecompany's Web site at www.abbott.com.
ots Originaltext: Abbott LaboratoriesIm Internet recherchierbar: http://www.presseportal.de
Contact: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
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