|By PR Newswire||
|May 7, 2013 07:03 PM EDT||
WOODCLIFF LAKE, N.J., May 7, 2013 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Drug Enforcement Administration (DEA) has placed BELVIQ (pronounced BEL-VEEK) into Schedule IV of the Controlled Substances Act. This information is expected to be published in the Federal Register on May 8, with an effective date of June 7, 2013. Eisai will issue a public statement when BELVIQ is available in the U.S.
BELVIQ was approved by the FDA on June 27, 2012 for chronic weight management in adults who are overweight with a comorbidity or obese.
About BELVIQ (lorcaserin HCl) Tablets
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known. BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence.
BELVIQ is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a:
- Body mass index (BMI) of 30 kg/m2 or greater (obese), or
- BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes.
Limitations of Use:
- The safety and effectiveness of BELVIQ in combination with prescription, over-the-counter, and herbal weight loss products is not known.
- It is not known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke.
Important Safety Information
- Pregnancy: Do not take BELVIQ if you are pregnant or planning to become pregnant. BELVIQ may harm your unborn baby, as weight loss offers no potential benefit to a pregnant woman.
- Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using BELVIQ, tell your doctor about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life-threatening side effects if taken with BELVIQ. Call your doctor right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles.
- Valvular heart disease: Some people taking medicines like BELVIQ have had heart valve problems. Call your doctor right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ, tell your doctor if you have or have had heart problems.
- Changes in attention or memory: BELVIQ may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ affects you.
- Mental problems: Taking too much BELVIQ may cause hallucinations, feeling high or in a very good mood, or feelings of standing outside of your body.
- Depression or thoughts of suicide: Call your doctor right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide.
- Low blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ. Changes to diabetes medication may be needed if low blood sugar develops.
- Painful erections: If you have an erection lasting more than 4 hours while on BELVIQ, stop using BELVIQ and call your doctor or go to the nearest emergency room right away.
- Slow heart beat: BELVIQ may cause your heart to beat slower.
- Decreases in blood cell count: BELVIQ may cause your red and white blood cell count to decrease.
- Increase in prolactin: BELVIQ may increase the amount of a hormone called prolactin. Tell your doctor if your breasts begin to make milk or a milky fluid or if you are a male and your breasts begin to increase in size.
- Most common side effects in patients without diabetes: Headache, dizziness, fatigue, nausea, dry mouth, and constipation.
- Most common side effects in patients with diabetes: Low blood sugar, headache, back pain, cough, and fatigue.
- Nursing: BELVIQ should not be taken while breastfeeding.
- Drug Interactions: Before taking BELVIQ, tell your doctor if you take medicines for depression, migraines or other medical conditions such as: triptans, medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic), tramadol, dextromethorphan (an over-the-counter (OTC) common cold/cough medicine), OTC supplements such as tryptophan or St. John's Wort, or erectile dysfunction medicines.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
SOURCE Eisai Inc.
Continuous testing helps bridge the gap between developing quickly and maintaining high quality products. But to implement continuous testing, CTOs must take a strategic approach to building a testing infrastructure and toolset that empowers their team to move fast. Download our guide to laying the groundwork for a scalable continuous testing strategy.
Jul. 23, 2016 09:00 PM EDT Reads: 1,800
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
Jul. 23, 2016 08:45 PM EDT Reads: 1,630
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 08:30 PM EDT Reads: 2,007
CenturyLink has announced that application server solutions from GENBAND are now available as part of CenturyLink’s Networx contracts. The General Services Administration (GSA)’s Networx program includes the largest telecommunications contract vehicles ever awarded by the federal government. CenturyLink recently secured an extension through spring 2020 of its offerings available to federal government agencies via GSA’s Networx Universal and Enterprise contracts. GENBAND’s EXPERiUS™ Application...
Jul. 23, 2016 08:30 PM EDT Reads: 1,760
Big Data engines are powering a lot of service businesses right now. Data is collected from users from wearable technologies, web behaviors, purchase behavior as well as several arbitrary data points we’d never think of. The demand for faster and bigger engines to crunch and serve up the data to services is growing exponentially. You see a LOT of correlation between “Cloud” and “Big Data” but on Big Data and “Hybrid,” where hybrid hosting is the sanest approach to the Big Data Infrastructure pro...
Jul. 23, 2016 08:00 PM EDT Reads: 1,771
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Jul. 23, 2016 08:00 PM EDT Reads: 2,400
In his session at 18th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., and Logan Best, Infrastructure & Network Engineer at Webair, focused on real world deployments of DDoS mitigation strategies in every layer of the network. He gave an overview of methods to prevent these attacks and best practices on how to provide protection in complex cloud platforms. He also outlined what we have found in our experience managing and running thousands of Linux and Unix ...
Jul. 23, 2016 07:45 PM EDT Reads: 1,653
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
Jul. 23, 2016 07:15 PM EDT Reads: 1,860
We all know the latest numbers: Gartner, Inc. forecasts that 6.4 billion connected things will be in use worldwide in 2016, up 30 percent from last year, and will reach 20.8 billion by 2020. We're rapidly approaching a data production of 40 zettabytes a day – more than we can every physically store, and exabytes and yottabytes are just around the corner. For many that’s a good sign, as data has been proven to equal money – IF it’s ingested, integrated, and analyzed fast enough. Without real-ti...
Jul. 23, 2016 07:00 PM EDT Reads: 837
"We view the cloud not really as a specific technology but as a way of doing business and that way of doing business is transforming the way software, infrastructure and services are being delivered to business," explained Matthew Rosen, CEO and Director at Fusion, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 07:00 PM EDT Reads: 1,423
"Software-defined storage is a big problem in this industry because so many people have different definitions as they see fit to use it," stated Peter McCallum, VP of Datacenter Solutions at FalconStor Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 06:30 PM EDT Reads: 1,336
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Jul. 23, 2016 06:15 PM EDT Reads: 772
With 15% of enterprises adopting a hybrid IT strategy, you need to set a plan to integrate hybrid cloud throughout your infrastructure. In his session at 18th Cloud Expo, Steven Dreher, Director of Solutions Architecture at Green House Data, discussed how to plan for shifting resource requirements, overcome challenges, and implement hybrid IT alongside your existing data center assets. Highlights included anticipating workload, cost and resource calculations, integrating services on both sides...
Jul. 23, 2016 06:00 PM EDT Reads: 1,874
"We provide DevOps solutions. We also partner with some key players in the DevOps space and we use the technology that we partner with to engineer custom solutions for different organizations," stated Himanshu Chhetri, CTO of Addteq, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 05:30 PM EDT Reads: 1,531
In his session at @DevOpsSummit at 19th Cloud Expo, Yoseph Reuveni, Director of Software Engineering at Jet.com, will discuss Jet.com's journey into containerizing Microsoft-based technologies like C# and F# into Docker. He will talk about lessons learned and challenges faced, the Mono framework tryout and how they deployed everything into Azure cloud. Yoseph Reuveni is a technology leader with unique experience developing and running high throughput (over 1M tps) distributed systems with extre...
Jul. 23, 2016 05:30 PM EDT Reads: 1,985