Navigation Links
Abbott Statement on the FDA Advisory Committee Recommendation on Sibutramine
Date:9/15/2010

Abbott Statement on the FDA Advisory Committee Recommendation on Sibutramine -- ABBOTT PARK, Ill., Sept. 15 /PRNewswire-FirstCall/ --


Advanced Search Search

  
Close
  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Health Care & Hospitals, Medical Equipment, Pharmaceuticals, FDA Approval Click to view news release full screen  

Abbott Statement on the FDA Advisory Committee Recommendation on Sibutramine

 

ABBOTT PARK, Ill., Sept. 15 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT (Sibutramine Cardiovascular OUTcome Trial) and the weight loss medication sibutramine (sold as Meridia® in the United States).  In response to the Advisory Committee's mixed vote, Abbott (NYSE: ABT) issued the following statement:

"Today's vote highlights the complexity of this scientific debate," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.  "We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine.  Sibutramine is an important option for patients and physicians to treat a serious condition for which there are few treatment options currently available, and Abbott has proposed comprehensive risk management tools to ensure that physicians and patients have the most relevant information for the continued appropriate use of sibutramine."

"Sibutramine has been studied in more than 100 clinical trials involving more than 20,000 patients, in addition to those involved in the SCOUT study," said Sun.  "SCOUT did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended and its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee will be considered by the FDA during its decision-making process for Meridia.  Abbott intends to consult with the FDA on sibutramine moving forward.

Sibutramine is approved for weight loss in patients who are either obese or overweight, and have no previous history of cardiovascular disease.  The approximately 10,000-patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment.  More than 90 percent of the patients studied in SCOUT had underlying cardiovascular disease or were otherwise ineligible to receive sibutramine under the current labeling and prescribing information.

UseMeridia (sibutramine hydrochloride monohydrate) is a prescription medicine used to help overweight or obese people lose weight.  Meridia should be used together with a low-calorie diet.

Important Safety InformationMeridia is not for everyone.  People should not take Meridia if they"

  • have or have had, heart problems, including:
  • heart attack
  • chest pain
  • heart failure
  • fast or irregular heart beat
  • hardening of their arteries or other blood vessels
  • poor circulation in their legs
  • have or have ever had a stroke or symptoms of a stroke.
  • uncontrolled or poorly controlled blood pressure (above 145/90).
  • are over age 65.
  • are taking or have taken a type of medicine used to treat depression called a monoamine oxidase inhibitor (MAOI) in the past 2 weeks.  MAOIs should not be taken for at least 2 weeks before using Meridia.  MAOIs should not be taken for at least 2 weeks after stopping Meridia.  People should ask their doctor or pharmacist if they are not sure if any of their medicines are MAOIs.
  • have an eating problem called anorexia nervosa or bulimia nervosa.
  • are taking certain other weight loss medicines.
  • are allergic to sibutramine hydrochloride monohydrate or any other ingredients in Meridia.

  • Meridia can cause serious side effects including large increases in blood pressure or heart rate (pulse) in some people.  Patients should call their doctor right away if they check their blood pressure and it is higher than normal for them, or if they have symptoms of high blood pressure such as headache, dizziness or blurred vision.

    Before starting Meridia, patients should have their blood pressure and heart rate checked by their doctor.  Their doctor should continue checking their blood pressure regularly while taking Meridia.  It is important that patients have regular check-ups with their doctor while they are taking Meridia.

    People should not take Meridia if they have severe liver or kidney disease, are pregnant or planning to get pregnant or if they are nursing.

    Patients should tell their doctor if they have or ever have had glaucoma, kidney or liver problems, seizures, bleeding problems, gallstones or depression, are pregnant or planning to become pregnant, or are breastfeeding.

    Using Meridia with certain other medicines may affect how Meridia or the other medicines work.  Patients should tell their doctor about all the medications they take, including prescription and non-prescription medicines, vitamins and herbal supplements.  Patients should especially tell their doctor if they take: a monoamine oxidase inhibitor (MAOI) medicine, other weight loss medicines, cough and cold medicines, migraine headache medicines, medicines used to treat depression, narcotic pain medications, lithium, tryptophan, or medicines that thin the blood.

    Meridia may cause serious side effects, including:

  • Serotonin syndrome, which may happen when people take Meridia with certain other medicines that affect a brain chemical called serotonin.  Patients should not take other medicines with Meridia unless their doctor has told them to.  Patients should get medical help right away if they have any of the following symptoms:
  • feel weak, restless, confused or anxious
  • lose consciousness (faint)
  • have a fever, vomiting, sweating, shivering or shaking
  • have a fast heart beat
  • seizures (convulsions, fits)
  • bleeding.  Bleeding may happen if patients have a condition that causes bleeding or if they take a blood thinning medicine.

  • Certain weight loss medicines have a rare but life-threatening problem that affects blood pressure in the lungs (pulmonary hypertension).  It is not known if Meridia may cause this problem.  Patients should call their doctor right away if they have new or worsening shortness of breath.

    The most common side effects include dry mouth, loss of appetite, trouble sleeping, constipation and headache.

    Patients should not drive, operate heavy machinery or do other dangerous activities until they know how Meridia affects them.

    Never give Meridia to anyone else because it may cause death or harm them.  Selling or giving away this medicine is against the law.

    This is some of the most important information to know about Meridia.  For more information, patients should talk with their health care provider.

    About AbbottAbbott 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 approximately 83,000 people and markets its products in more than 130 countries.

    Abbott information is available on the company's Web site at www.abbott.com.


    '/>"/>

    SOURCE Abbott
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Abbott Honored for Workplace Leadership for the Tenth Consecutive Year by Working Mother Magazine
    2. Abbott Included on the Dow Jones Sustainability Indexes for Six Consecutive Years in Recognition of Leading Corporate Citizenship Performance
    3. Abbott Completes Acquisition of Piramals Healthcare Solutions Business, Becomes Leading Pharmaceutical Company in India
    4. Abbott Receives FDA Approval for First Automated Molecular Test for Assessing Hepatitis B Treatment
    5. Abbott to Present at Morgan Stanley Global Healthcare Unplugged Conference
    6. Abbotts SIMCOR ® ( niacin extended-release / simvastatin ) Receives FDA Approval for New Dosage Strengths
    7. Abbott to Feature Novel Tests and New Upgrades to Testing Platforms at American Association for Clinical Chemistry Lab Expo
    8. Abbott Receives FDA Clearance for Molecular Diagnostic Test for Detection of Chlamydia and Gonorrhea Infections
    9. Abbott to Present Data on Several Investigational Cancer Treatments at American Society of Clinical Oncology Annual Meeting
    10. The New England Journal of Medicine Publishes Results of Landmark CREST Study, Showing Similar Positive Outcomes for Abbotts Carotid Stent System and Surgery
    11. Abbotts Groundbreaking Bioresorbable Technology Continues to Demonstrate Exceptional Clinical Results
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:2/8/2016)... , February 8, 2016 ... new market research report "Ablation Technologies Market by Product ... Cancer, Pain Management, Cosmetic Surgery, Ophthalmology, Gynecology) - Global ... the global market over the forecast period of 2015 ... Billion by 2020, at CAGR of 10.5% from 2015 ...
    (Date:2/8/2016)... Pa. , Feb. 8, 2016   ... November Research Group (NRG),s pharmacovigilance technology services ... system-related consulting services and an Oracle Argus Specialized ... services to Life Sciences companies. ... and expands HighPoint,s life sciences capabilities and provides ...
    (Date:2/8/2016)...  As part of a major growth and expansion initiative, ... Lori Chmura as President of Dune Inc., its ... Chmura,s extensive experience in the medical device space will play ... --> --> In ... sales, marketing and operational functions in the U.S. She is ...
    Breaking Medicine Technology:
    (Date:2/8/2016)... ... February 08, 2016 , ... Remember the old saying “rub ... According to Perry A~, author of “Calcium Bentonite Clay” the health benefits of integrating ... balancing and detoxifying the body. , A former motivational speaker, Perry A~ has since ...
    (Date:2/8/2016)... ... , ... FileHold's document management software has been implemented by ... environment for FileHold software that is pay per user subscription-based and also does ... FileHold web services API. DocuSyst also advises clients on fully functioning back up ...
    (Date:2/8/2016)... ... February 08, 2016 , ... GrassrootsHealth published data from its ... 2 diabetes in the GrassrootsHealth cohort with substantially higher vitamin D levels than ... public health,” states Carole Baggerly, Director of GrassrootsHealth, “the safety and benefits ...
    (Date:2/8/2016)... ... , ... TopConsumerReviews.com recently awarded their highest five-star rating to a product from ... a cluster of melanin when exposed to sunlight. Although most moles are benign and ... embarrassment. Historically, mole removal has involved a painful, often expensive visit to ...
    (Date:2/8/2016)... NV (PRWEB) , ... February 08, 2016 , ... Guruji ... February 9th, 10th and 11th, 2016 in honor of his birthday on February 10th. ... true happiness. Mahendra Trivedi is known by over 250,000 people from over 40 ...
    Breaking Medicine News(10 mins):