Navigation Links
FDA Probing Possible Link Between Asthma Drug and Suicide Risk
Date:3/27/2008

the U.S. Food and Drug Administration to provide further clarity in the product label as well as to further communicate this information to physicians."

Over the past year, Merck has updated prescribing information for the drug to include information on several adverse events including tremor, depression, suicidality (suicidal thinking and behavior) and anxiousness, according to the FDA. And Merck plans to convey recent labeling changes in face-to-face meetings with prescribers and also in patient leaflets.

The FDA has asked Merck to look at Singulair study data for more information about suicidality and suicide. The agency itself is reviewing post-marketing reports of adverse events.

In its statement, Merck detailed the nature of those adverse events. "In a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with Singulair, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received Singulair," the statement read. "Additionally, in a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, clinical trials that compared Singulair with other active agents to treat asthma [which included over 3,900 adults and children who were treated with Singulair and over 3,400 who were treated with other asthma therapies], there was one patient who attempted suicide who received Singulair, and there were three patients who attempted suicide who received other asthma therapies [including inhaled corticosteroids and long-acting beta-agonists]."

The FDA noted it was also looking into whether other related drugs, such as Accolate, Zyflo and Zyflo CR need to be investigated as well.

"Due to the complexity of the analyses," the FDA said, it anticipates that it may take up to nine months to complete the ongo
'/>"/>

Copyright©2008 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Fairbank Farms Voluntarily Recalls 85% Ground Round Beef Patties Sold Fresh from Shaws Due to Possible Health Risk
2. M.D. Anderson-led team reports possible key to autoimmune disease
3. AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks with ADHD Medications
4. Possible safer target for anti-clotting drugs found
5. Jefferson researchers uncover new evidence of prolactins possible role in breast cancer
6. Why it is impossible for some to just say no
7. Saving Millions of Childrens Lives Is Possible
8. Mayo Clinic Proceedings article explores possible link between obesity and viral infections
9. Mayo Clinic reports possible new therapy for patients with platinum-resistant ovarian cancer
10. Help for California Fire Evacuees Possible Through Partnership for Prescription Assistance
11. Mayo Clinic study points to a possible biomarker for colon cancer in people 50 and under
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Probing Possible Link Between Asthma Drug and Suicide Risk
(Date:12/26/2014)... 2014 Parker & Sons, Inc. ... in heating, cooling and plumbing contractor services throughout ... services in 2014 with regard to air-conditioning systems. ... is known for its incredibly hot summers. Working ... intricacies and details of a wide variety of ...
(Date:12/25/2014)... 2014 The click strand ... strength and durability. Today, the business announces a ... valid until Jan. 30, 2015. , Click strand ... hardwood. BambooFlooringChina.com is a well-known brand in the ... to find a reliable bamboo flooring supplier. , ...
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company supplying ... of discounted prom dresses, most of which are priced ... the company, the promotion is valid until Jan. 22, ... the UK market. , The prom dresses in this ... styles: A-line strapless, empire strapless chiffon, one shoulder, floor-length, ...
(Date:12/25/2014)... sells many bamboo products and the business is famous ... announces big discounts on its bamboo mats , which ... the world’s leader in bamboo flooring. According to the ... 2015. , The bamboo mats are made from well-treated ... the bamboo strips for the mats are boiled and ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2
... the popularity of,fillers becoming mainstream, it,s no surprise ... facial wrinkles. Dr. Arnold Klein, world,renowned cosmetic dermatologist ... such as Artefill, Radiesse and Sculptra contain injectable,plexiglass, ... all of,these products can cause foreign body reactions," ...
... in the Annals,of Emergency Medicine ("Increasing Rates of Emergency ... to 2003") finds the rate of,elderly Americans seeking emergency ... Kenneth L. Noller, MD, President of the American College ... on behalf of the Alliance of Specialty Medicine., ...
... warn of surge in cardiovascular troubles by 2035 , , ... adolescents are more likely to be overweight or obese ... and death, two new studies conclude. , The first, ... are at an increased risk of coronary heart disease ...
... LANCASTER, Pa., Dec. 5 Eastern Insurance,Holdings, Inc. (Nasdaq: ... board of directors has authorized a $0.05 per share ... common stock, payable,December 28, 2007 to shareholders of record ... EIHI is the parent company of Eastern Life and ...
... Pharmaceuticals, Inc.,(Nasdaq: IDEV ) today announced the Company ... Thursday, December 13, 2007 at 12:30 PM,Eastern Time. The ... will be web cast live and may be accessed ... http://www.indevus.com ., About Indevus, Indevus Pharmaceuticals, ...
... (SACRAMENTO, Calif.) -- Apart from a more complicated ... amounts of time with their patients" Researchers at ... practice-specific characteristics that affect the length of a ... satisfaction with the doctors visit. , In ...
Cached Medicine News:Health News:Facial Deformity Danger? 2Health News:Dramatic Growth Projected in Visits by Elderly Patients to Emergency Departments Underscores Urgency of Medicare Physician Payment Fix 2Health News:Overweight Kids Often Become Obese, Unhealthy Adults 2Health News:Overweight Kids Often Become Obese, Unhealthy Adults 3Health News:Eastern Insurance Holdings, Inc. Announces Quarterly Dividend 2Health News:Eastern Insurance Holdings, Inc. Announces Quarterly Dividend 3Health News:Indevus Pharmaceuticals To Present at RBC Capital Markets Conference 2Health News:Indevus Pharmaceuticals To Present at RBC Capital Markets Conference 3Health News:New UC Davis study finds physician style and HMO affiliation impact lengths of patient visit 2
(Date:12/24/2014)...  Novastem, a leader in regenerative medicine, announces ... study for ischemic stroke at Clinica Santa Clarita. ... account for 87 percent of all stroke cases. ... study, entitled "Internal Research Protocol in Combination Therapy ... and Intrathecal Administration of Neural Stem Cells in ...
(Date:12/24/2014)... 2014  Commonwealth Cornerstone Group (CCG) today announced the completion ... Tuesday to help fund the expansion and consolidation of healthcare ... Sharon . PHN is the largest ... . It is the largest employer in Sharon,s ... on staff. Currently, PHN Sharon offers scattered services ...
(Date:12/24/2014)... BUFFALO, N.Y. , Dec. 24, 2014 ... been dosed with KX2-361 at Roswell Park Cancer Institute. ... a small molecule drug that has shown potent inhibitory ... lines, including those that are resistant to Temozolomide (T98G), ... malignant glioma. In a well-established brain tumor mouse model, ...
Breaking Medicine Technology:Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 2Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 3Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 4Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 2Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 3Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 2Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 3
... Calif., May 25, 2012 Depomed, Inc. (NASDAQ: ... the Jefferies Global Health Care Conference in New York City. ... for 10:30 am EDT (7:30 am California time) on Monday, ... webcast can be accessed via the Investor Relations page of ...
... innovative products for inpatient physician management and automated revenue ... MasterCoder 2.0 , a physician coding application that increases ... compliance. MasterCoder essentially walks physicians through the coding process ... charge in conjunction with their patient documentation. ...
Cached Medicine Technology:Physician-Friendly Coding and Compliance Tool Increases Accuracy and Documentation of Patient Charges 2Physician-Friendly Coding and Compliance Tool Increases Accuracy and Documentation of Patient Charges 3
... This BioSafe room is configured specifically ... and chemical analysis. Panels are precision-joined ... easy to wipe down and disinfect. ... double-wall panel design creates strong, rigid ...
... Features hardwall acrylic panels ... frame to form a free-standing ... to Class 10/ISO 3. Optional ... and ionizers are configured to ...
... curtains or parting strip shields ... frame to form a free-standing, ... cleanliness to Class 10/ISO 3. ... lights, and ionizers are configured ...
... cleanroom for biological safety labs (BSL) ... (to Class 10/ISO 3) and easy ... ultra-smooth surfaces that are easy to ... corners simplify cleaning. Unique double-wall panel ...
Medicine Products: