Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia

Featured In: Regulatory News

By Federal Drug Administration Friday, January 22, 2024

Loading...

Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia

[01-21-2010] The U.S. Food and Drug Administration (FDA) has reviewed additional data that indicate an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine, marketed as the weight loss medication Meridia. The sibutramine drug label already includes warnings against the use of sibutramine in patients with cardiovascular disease. However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label.

The contraindication will state that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

  • History of coronary artery disease (e.g., heart attack, angina)
  • History of stroke or transient ischemic attack (TIA)
  • History of heart arrhythmias
  • History of congestive heart failure
  • History of peripheral arterial disease
  • Uncontrolled hypertension (e.g., > 145/90 mmHg)

 

Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.

Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using sibutramine and if sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued. Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk.

The Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care. Patients included in the study were 55 years of age or older, overweight or obese, and had a history of cardiovascular disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study. Approximately 10,000 patients enrolled in the study.

The November 2009 Early Communication from FDA described preliminary results from the SCOUT study indicating cardiovascular events occurred in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference was higher than expected, suggesting that sibutramine was associated with an increased cardiovascular risk in the study population.

The additional data from the SCOUT study reviewed by FDA indicate that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease.

The results for cardiovascular events for each subgroup of the SCOUT study are found in the table below.

TABLE 1. Cardiovascular Events in the SCOUT Study by Predefined Subgroups

Study Group †Placebo
(% of patients)
Sibutramine
(% of patients)
Hazard Ratio
(95% Confidence Interval)
p-value

DM Only Group 

Total patients (n) Cardiovascular Events*

1,178 77

(6.5%)

1,207 79

(6.5%)

1.010 (0.737, 1.383) 0.951

CV Only Group

Total patients (n) Cardiovascular Events*

793 66

(8.3%)

759 77

(10.1%)

1.274 (0.915, 1.774) 0.151

CV + DM Group 

Total patients (n) Cardiovascular Events*

2,901 346

(11.9%)

2,906 403

(13.9%)

1.182 (1.024, 1.354) 0.023†â€

†Patients in the SCOUT study comprised 3 subgroups: 1) History of type 2 diabetes but no cardiovascular disease (DM only subgroup); 2) History of cardiovascular disease (CV only subgroup); 3) History of cardiovascular disease and type 2 diabetes (CV + DM subgroup).
* Defined as heart attack, stroke, resuscitated cardiac arrest, or cardiovascular death.
††Statistically significant result.

Once FDA completes its review of the full study report for SCOUT, which is expected to be submitted to the FDA by the sponsor in March 2010, and other relevant information related to sibutramine’s potential benefits and risks, an open public advisory committee meeting will be convened to discuss sibutramine’s benefit/risk profile and to determine if additional regulatory actions should be taken to ensure safe use of the medication.

    

SOURCE

Join the Discussion
Rate Article: Average 0 out of 5
register or log in to comment on this article!

0 Comments

Add Comment

Text Only 2000 character limit

Page 1 of 1

Research Exchange

Publishing Data That Conform to the MIQE Guidelines

Jan 22

Minimum information for publication of Quantitative Real-Time PCR Experiments (MIQE) guidelines help researchers design qPCR experiments.

Calibration Free Analysis to Measure the Concentration of Active Proteins

Nov 23 2009

An SPR-based method, Calibration Free Concentration Analysis can be used to accurately determine the concentration of active protein in a sample, relating to the specific binding activity of the protein, and without the need for a standard.

Advances in EMCCD Technology: Making Imaging Less Arbitrary

Nov 16 2009

Recent advances in EMCCD technology have solved the problem of non-standardized measurement units by using the photoelectron to standardize imaging experiments.

10 Tips for Successful Sample Concentration and Buffer Exchange

Nov 6 2009

Centrifugal devices with ultrafiltration (UF) membrane can solve common problems researchers face when working with proteins.

Advantages of Monolithic Laser Combiner Technology in Confocal Microscopy Systems

Jan 6

Fluorescence microscopy techniques require a reliable light source at the desired wavelength or wavelengths, with minimal downtime for maintenance and alignment. Lasers are a popular light source, although the alignment and upkeep of laser combiners is a time-consuming prospect for many users.

Size-Exclusion Chromatography for Purification of Biomolecules

Dec 2 2009

Size-exclusion chromatography (SEC) is a popular method to separate biomolecules based on their size. Primarily, it is applied to the separation of biopolymers such as proteins and nucleic acids, i.e. water-soluble polymers.

Improving Separation During Electrophoresis

Dec 2 2009

SeparateIT gels represent a novel gel matrix for DNA electrophoresis. Gel polymers are arranged in a conceptually different way, in accordance with a new theoretical model of gel electrophoresis.

Improving Quality of ELISA

Dec 2 2009

Using ready-to-use ELISA kits from manufacturers is easy and convenient. Sometimes however, home-made ELISA is required because there is no kit available with the right antibodies or the characteristics of the available kits such as their limits of detection are not appropriate.

Attention Deficit & Hyperactivity in a Drosophila Memory Mutant

Attention Deficit & Hyperactivity in a Drosophila Memory Mutant

Nov 9 2009

Action selection is modulated by external stimuli either directly or via memory retrieval. In a constantly changing environment, animals have evolved attention-like processes to effectively filter the incoming sensory stream. These attention-like processes, in turn, are modulated by memory. The neurobiological nature of how attention, action selection and memory are inter-connected is unknown. We describe here new phenotypes of the memory mutant radish in the fruit fly Drosophila.

Mechanisms of plasticity in simple taxis behaviors in Drosophila

Nov 8 2009

Like the proverbial moth drawn to the candle flame, the fruit fly Drosophila also stereotypically approaches light sources. This positive phototaxis is the archetypal example of hard-wired input-output behaviors.

Live cell imaging of mutant and wild-type GABA-A receptor trafficking using a novel reporter protein

Nov 8 2009

Efficient signaling in the brain requires precise regulation and targeting of cell surface ion-channels. Mutations in these channels associated with inherited diseases can cause improper targeting and reduced surface expression.

ADP-Glo™: An Ideal Approach to Monitor the Activity of Protein Kinases and Beyond

Oct 16 2009

Because of its versatility (alltypesofsubstrates), robustness (Z’>0.8), rapidperformance, and its ease of use, the luminescence based Kinase Glo® assay platform has gained wide acceptance in many drug screening programs for protein kinase inhibitors.

Erroneous automated optical platelet counts in 1-hour post-transfusion blood samples.

Jan 23

Summary Thrombocytopenic patients with acute leukemia may show high post-transfusion count increments that significantly exceed the number of transfused platelets. This study demonstrates that the automated hematology analyzer Sysmex XE-2100 reports erroneously high optical...

Evaluation of a capillary blood collection system for screening for hemoglobinopathies in remote areas.

Jan 23

Summary Accurate estimation of hemoglobin (Hbs) A, Hb A(2), Hb F and abnormal Hb is required for diagnosis of hemoglobinopathies and genetic counseling. High pressure liquid chromatography (HPLC) is the most suitable approach available. But for 70% of the rural Indian...

Multiplex fluorescence in situ hybridization in identifying chromosome involvement of complex karyotypes in de novo myelodysplastic syndromes and acute myeloid leukemia.

Jan 23

Summary Complex chromosomal aberrations (CCA) can be detected in a substantial proportion of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), which are associated with very poor prognosis. Conventional cytogenetics (CC) cannot accurately define the specific...

Prokariotic Cell Collection in Denmark

Nov 6 2009

I would like to know about a prokariotic cell collection in Denmark. Is there a cell bank in this country? I need a Lactobacillus strain for a fermentation assay and this information about the bank is very helpful for me.

Request for Entries

Oct 16 2009

Ask the Experts is your chance to get the answers to questions on applications, materials, methods, processes, and technologies. Email you question to bst_web@advantagemedia.com, and the editors of Bioscience Technology will find an appropriate expert to answer it. Watch this space in the future to see the questions your colleagues are posting.

STAY INFORMED: SUBSCRIBE TO

Magazine and E-mail Newsletters

Loading...
E-mail:   

MULTIMEDIA

Video:

Neuroscience Diseases of The Brain and How The Mind Emerges

Neuroscience Diseases of The Brain and How The Mind Emerges

Nov 8 2009

Dennis Choi, director of Emory Universitys Neuroscience Center, is renowned for his groundbreaking research on brain and spinal cord injury.

Podcasts:

Allen Institute for Brain Research

Allen Institute for Brain Research

Oct 14 2009

Discussed in this interview are both the mouse brain project and the human cortex project with an emphasis on the importance of these projects to neuroscience research.

Information: