Navigation Links
FDA Issues Multiple Sclerosis Drug Alert
Date:5/14/2012

MONDAY, May 14 (HealthDay News) -- The multiple sclerosis drug Gilenya (fingolimod) should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems, says a U.S. Food and Drug Administration safety announcement issued Monday.

The warning follows the FDA's evaluation of a report of a patient who died within 24 hours after receiving the first dose of Gilenya. The agency also reviewed additional clinical trial and post-approval data for the drug, including reports of patients who died of cardiovascular or unknown causes.

While it couldn't definitively conclude that Gilenya was related to any of the deaths, the FDA said it has concerns about the cardiovascular effects of the drug after the first dose. The data analysis showed that even though the maximum heart rate-lowering effect of the drug usually occurs within six hours of taking the first dose, this effect can occur as late as 20 hours after the first dose.

Along with the other recommendations, the FDA said that all patients starting Gilenya should be monitored for signs of a slow heart rate for at least six hours after the first dose and have hourly pulse and blood pressure measurements.

Patients should undergo electrocardiogram testing before receiving the drug and at the end of the observation period. In addition, extended cardiovascular monitoring should continue overnight in patients who are at higher risk for, or who may not tolerate, a slow heart rate (bradycardia).

These high-risk patients include those:

  • Who develop severe bradycardia after receiving the first dose of Gilenya.
  • With certain pre-existing conditions in whom bradycardia may be poorly tolerated.
  • Receiving therapy with other drugs that slow the heart rate or electrical impulses that regulate the heartbeat.
  • Who have a heart rhythm abnormality called
    '/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2

Related medicine news :

1. Genetic abnormalities in benign or malignant tissues predict relapse of prostate cancer
2. Radiologists rank themselves as less than competent on health policy issues
3. UCSF chancellor issues call-to-arms to patient advocates
4. Snoring Tots May Develop Behavioral Issues Later
5. U.S. Soldiers Face Host of Mental Health Issues
6. Younger breast cancer patients have more adverse quality-of-life issues
7. ATS issues joint statement on key issues and recommendations for critical care research
8. CDC Issues New TB Treatment Guidelines
9. American Society of Clinical Oncology issues annual report on progress against cancer
10. AAOS issues new clinical practice guideline for treating common elbow fractures in children
11. Experts Design Toolkit to Help Spot Teens With Mental Health Issues
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Issues Multiple Sclerosis Drug Alert
(Date:7/23/2014)... Steven Reinberg HealthDay Reporter ... Many obese and overweight American children and teens look ... fine, U.S. health officials reported Wednesday. "Being overweight ... as high blood pressure, high cholesterol and diabetes," said ... U.S. Centers for Disease Control and Prevention,s National Center ...
(Date:7/23/2014)... The next episode of “Extreme Weight Loss” ... was physically fit through childhood and adolescence. After becoming ... heart-wrenching decision to give her son up for adoption. ... years, and she punished herself by overeating, gaining nearly ... non-competitive approach to weight loss transformations, “Extreme Weight Loss” ...
(Date:7/23/2014)... 23, 2014 Home Care Assistance ... for seniors, is proud to announce the next installment ... in a wide range of health and wellness-related fields. ... and award-winning author Nancy Kriseman, and will cover the ... prevent burnout by becoming more self-aware. In particular, Nancy ...
(Date:7/23/2014)... Painful or itchy skin lesions could be a warning ... have multiple lesions that are suspicious looking, and those ... for non-melanoma skin cancers," study author Dr. Gil Yosipovitch, ... said in a Temple University Health System news release. ... patients who were confirmed to have skin cancer lesions ...
(Date:7/23/2014)... supports a growing body of research suggesting a ... in treating postmenopausal breast cancer, with fewer detrimental ... standard anti-hormone therapies. The study will be published ... Reproductive Biology and Endocrinology . , Breast ... women in the United States. Approximately 70% of ...
Breaking Medicine News(10 mins):Health News:Many Obese U.S. Kids Think They're Thinner Than They Are 2Health News:Many Obese U.S. Kids Think They're Thinner Than They Are 3Health News:“Extreme Weight Loss”: Cassie’s journey begins at the University of Colorado Anschutz Health and Wellness Center 2Health News:Home Care Assistance Calgary to Host Public Webinar on the Topic of Caregiver Mindfulness 2Health News:Home Care Assistance Calgary to Host Public Webinar on the Topic of Caregiver Mindfulness 3Health News:Painful, Itchy Patches Could Be Sign of Skin Cancer 2Health News:Hormones after breast cancer: Not fuel for the fire after all? 2Health News:Hormones after breast cancer: Not fuel for the fire after all? 3Health News:Hormones after breast cancer: Not fuel for the fire after all? 4Health News:Hormones after breast cancer: Not fuel for the fire after all? 5
... Amanda Gardner HealthDay Reporter , FRIDAY, Dec. 16 ... who receive targeted radiation to the breast after a lumpectomy ... only about a third of these women were considered "suitable" ... study published in the Dec. 16 online issue of the ...
... SAGE and the European Society of Cardiology (ESC) ... Journal: Acute Cardiovascular Care. The first issue will be ... represents over 70,000 cardiology professionals across Europe and the ... including publishing seven of the world,s leading cardiology journals. ...
... 17 (HealthDay News) -- The busy holiday season may disrupt ... it is especially important to remember to look after your ... people to consume sugary treats and drink alcoholic beverages more ... General Dentistry, said in an academy news release. "Additionally, ...
... Will a drug used to treat childhood acute lymphoblastic leukemia ... UB associate professor of pharmaceutical sciences, Javier G. ... research and clinical practice, has focused recent efforts on trying ... study in the Journal of Clinical Oncology looked for the ...
... Scientists may have a way to double the efficacy ... Sciences University scientists have devised a way to reduce lung ... caused by radiation therapy., "Radiation is a great therapy ... Dynan, biochemist and Associate Director of Research and Chief, Nanomedicine ...
... FRIDAY, Dec. 16 (HealthDay News) -- Chronic pain can ... the affected partner,s ability to cope with the pain, ... shown that validation of a spouse,s emotions (showing respect ... invalidation of emotions (showing hostility or no interest) increases ...
Cached Medicine News:Health News:Targeted Radiation for Breast Cancer May Be Overused: Study 2Health News:Targeted Radiation for Breast Cancer May Be Overused: Study 3Health News:Sage and European Society of Cardiology extend publishing partnership 2Health News:Dentist Gives Advice to Keep Holiday Smiles Bright 2Health News:Childhood cancer drugs cure now, may cause problems later, UB research shows 2Health News:Scientists may be able to double efficacy of radiation therapy 2Health News:Spouse's Reaction May Affect Pain Management 2
(Date:7/23/2014)... On Tuesday, July 1, 2014, ... the 116 th Judicial District Court in ... RegenLab USA, LLC ("Defendant") for Tortious ... through false and misleading actions, fraud, fraud-in-the-inducement, business ... through libel, disparagement, defamation, misrepresentation, and violating the ...
(Date:7/23/2014)... Creekridge Capital, an independent vendor-focused finance ... so far in 2014 to their portfolio of ... from both the healthcare and technology industries. They ... multi-national companies. Each of these new vendors take ... including: standard leasing products, subscription solutions, a dedicated ...
(Date:7/23/2014)...  Mezzion Pharma Co. Ltd., announced that it has ... udenafil to treat adolescents who have undergone the Fontan ... program will follow protocols developed by a subcommittee made ... a multi-center clinical research network funded by the National ... Institutes of Health (NIH). The studies, ...
Breaking Medicine Technology:Creekridge Capital Signs Several New Vendor Partners 2Mezzion Pharma Initiates Clinical Development Program To Evaluate Udenafil In Adolescents With Single Ventricle Heart Defects 2
... (Nasdaq: BMRN ) today hosted a Research ... team and industry experts provided an update on BioMarin,s ... pipeline. "We believe 2011 has been a ... and early stage clinical development programs," said Jean-Jacques Bienaime, ...
... Modern Materials Division of Heraeus Kulzer, LLC, the ... The division has been the leader in the U.S. dental ... Modern Materials was founded in 1946 in St. Louis, ... chemist, was "Mr. Inside" while Mr. Piper, the consummate salesman, ...
Cached Medicine Technology:Highlights from BioMarin's Research & Development Day 2Highlights from BioMarin's Research & Development Day 3Highlights from BioMarin's Research & Development Day 4Highlights from BioMarin's Research & Development Day 5Highlights from BioMarin's Research & Development Day 6Heraeus' Modern Materials Division Celebrates 65th Anniversary 2Heraeus' Modern Materials Division Celebrates 65th Anniversary 3
Large image and wide-angle design....
Large-image field with titanium couplers for c-mount scopes. 30mm focal length....
High intensity lamp with built-in, switchable spare lamp. Low-noise fan with reduced air turbulence....
PDA application listing specific ICD-9 coding listed in new Medicare National Coverage Determinations....
Medicine Products: