Navigation Links
FDA Mandates New Warnings for Botox
Date:4/30/2009

Injection to relax muscle spasms carries severe risks, agency says,,

THURSDAY, April 30 (HealthDay News) -- Reports of deaths among people using popular anti-wrinkle injections such as Botox to treat muscle spasms have prompted a change in labeling.

Botox and similar products will now be required to carry boxed warnings, the most serious type of label warning, the U.S. Food and Drug Administration announced Thursday.

Most cases involved children given the drug to control muscle spasticity associated with cerebral palsy and adults using it to treat muscle spasticity, migraines and cervical dystonia.

"The hospitalizations are very few, deaths are very rare, but they have been reported," said Dr. Ellis F. Unger, acting deputy director of the FDA's Office of Drug Evaluation, said during a teleconference.

"We don't want to discourage use of these drugs as patients taking them have significant disability and the drugs are effective to relieve important problems," he said. "But people just need to understand the risks that are involved so they can make informed, risk-benefit decisions."

Other side effects include muscle weakness, difficulty breathing, loss of bladder control and pneumonia. Some people have required feeding tubes.

Unger said the deaths have not been clearly attributable to injection of the drugs, as everyone who died also suffered from other conditions.

None of the cases so far reported have been associated with use of botulinum products in cosmetic or dermatological procedures, such as clearing furrows between the eyebrows, according to the FDA. Botulinum toxins are not approved by the FDA to treat severe arm and leg muscle spasms, although they are approved for dermatological indications as well as cervical dystonia.

Officials believe that most of the problems occurred when one product was substituted for another without corresponding dose adjustments.'/>"/>

Copyright©2009 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Refuting Misconceptions About Health Insurance Mandates
2. Economic Stimulus Bill Mandates Electronic Health Records for Every American by 2014 - With No Opt-out Provision
3. Economic Stimulus Bill Mandates Electronic Health Records for Every Citizen without Opt-out or Patient Consent Provisions
4. FDA Mandates Black Box Warning for Some Antibiotics
5. Most Companies Oppose Single-Payer Health Care System, State Coverage Mandates
6. CAHI Releases Updated Health Insurance Mandates in the States
7. New Study: Health Insurance Mandates on Employers Hurt Low-Income Employees
8. ACM Helps Medicaid Programs Comply With Federal Deficit Reduction Act Mandates
9. FDA Adds New Label Warnings to Over-the-Counter Painkillers
10. Docs Override Most Electronic Drug Warnings
11. TransMedia Group Retained by Renowned Plastic Surgeon Dr. Jeffrey Lagrasso to Share Beauty Trends, Warnings and Medical Perspective Previously Limited to the Rich and Famous
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Mandates New Warnings for Botox
(Date:7/12/2014)... Wright & Schulte LLC has filed a DePuy Pinnacle ... Johnson & Johnson, on behalf of an Ohio man who ... DePuy Pinnacle hip replacement and had to undergo revision surgery ... DePuy hip lawsuit was filed July 7, 2014, in the ... where DePuy Pinnacle Hip lawsuit litigation is underway . ...
(Date:7/12/2014)... Doylestown Hospital recently conducted an interview with Dr. ... Paddock tackles topics including main men's health concerns, ... than men, and testosterone replacement therapy, among others. In ... on Doylestown Hospital’s website, Dr. Brad Paddock says, “A ... you notice pain, bulging, or asymmetry in your lower ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 Utah Valley ... of startups, with awards being bestowed to companies in ... Utah’s outstanding entrepreneur community with recognition for new ideas ... model with incoming revenue. , 25 Under 5 highlights ... state that are under 5 years old. Award recipients ...
(Date:7/12/2014)... 2014 A recent article released by Seattle's ... of suggestions for those seeking cosmetic surgical procedures in ... approaching and the heat begins to enliven the rainy Pacific ... clothing, realizing that they didn’t work out as much during ... cause a sudden surge of people eager to look their ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 Wright & Schulte ... clients in Just For Men Lawsuits (case #59776/2014), announces ... consumers of reports that allege the popular hair dye, Just ... burns to their face, neck and other areas. In addition ... For Men chemical burns , the advertisements being run by ...
Breaking Medicine News(10 mins):Health News:DePuy Pinnacle Hip Lawsuit Filed By Wright & Schulte LLC On Behalf of Ohio Man Who Required Revision Surgery Purportedly From Defective Hip Implant 2Health News:DePuy Pinnacle Hip Lawsuit Filed By Wright & Schulte LLC On Behalf of Ohio Man Who Required Revision Surgery Purportedly From Defective Hip Implant 3Health News:DePuy Pinnacle Hip Lawsuit Filed By Wright & Schulte LLC On Behalf of Ohio Man Who Required Revision Surgery Purportedly From Defective Hip Implant 4Health News:DePuy Pinnacle Hip Lawsuit Filed By Wright & Schulte LLC On Behalf of Ohio Man Who Required Revision Surgery Purportedly From Defective Hip Implant 5Health News:Ivyland Medical Center’s Dr. Brad Paddock Offers Tips for Men’s Health 2Health News:SquareHook is Recognized for UVEF 25 Businesses Under 5 Years-Watch Out 2Health News:Best Summer Cosmetic Surgeries Revealed in Article By Seattle Plastic Surgeon 2Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 2Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 3Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 4
... Interest Group to Enable an Internationally Interoperable ... ... Fla., Feb. 22 Liberty Alliance, the global,identity consortium working ... worldwide, today announced the launch of a,global public forum formed ...
... HIMSS ... - Booth 1835 -, ... excited to announce the continuing growth and maturation,of its Internet-based health ... Health Information Initiative has implemented the,Community MOMENT OF CARE(R) within Miami, ...
... scientists from the University Paris Descartes has solved the ... resistance to multiple types of antibiotics, according to a ... new clues as to how bacteria adapt to resist ... this defense mechanism. , Frdric Dardel and colleagues ...
... concerns about the dangers of kava and the effects ... as the US Food and Drug Administration and Australia,s ... kava and kava products. , Originally from Fiji, ... of Pharmacy at the University of Sydney, Australia, had ...
... of Denver study shows a curriculum-based bullying prevention program reduced ... in the study control group. , Jeffrey M. Jenson and ... of Social Work studied more than 1,100 students in 28 ... exposed to a bullying prevention program called Youth Matters (YM). ...
... their European counterparts, due in part to a higher rate ... in the United States, according to a study presented at ... to European men, U.S. men had 61 percent higher odds ... the odds of stroke as European women. , Most of ...
Cached Medicine News:Health News:Global Interoperability and Patient Privacy Focus of New Liberty Alliance Health Identity Management Group 2Health News:Cogon Systems, Inc. Supports the Formation of Virtual Health Communities with its Community MOMENT OF CARE(R) 2Health News:University of Sydney researchers find new evidence linking kava to liver damage 2Health News:University of Denver bullying victimization study 2Health News:Stroke more prevalent in United States than in Europe 2Health News:Stroke more prevalent in United States than in Europe 3
(Date:7/10/2014)... 10, 2014  The U.S. Department of Health and ... University Hospitals (UH) Case Medical Center Seidman Cancer Center ... aimed at improving care for patients with complex cancer. ... will test a unique model developed at UH to ... significant comorbidities, or demonstrated need for high health care ...
(Date:7/10/2014)... , July 10, 2014 Integrated Silicon ... in advanced memory and analog IC solutions, today announced ... Thursday, July 24, 2014, at 7:00 a.m. Pacific Time ... results for the fiscal 2014 third quarter ended June ... via telephone, dial 1-888-556-4997 before 6:50 a.m. Pacific time ...
(Date:7/10/2014)... 2014 Yesterday, former Congressman Patrick ... manufacturing facility. Rep. Kennedy and Dick Moberg ... cutting-edge research in neurological disease and treatment. ... advocate, Garen Staglin , created One Mind, ... changes that will radically accelerate the development and ...
Breaking Medicine Technology:University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 2University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 3University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 4Representative Patrick Kennedy visits Moberg's medical device facility to discuss improvement in brain injury care 2
... Greenville, SC, announced today that its Glucommander™ 2.0 Enterprise software ... 2 - 17. Glytec,s Glucommander was the first insulin dosing ... it is the only company to achieve specific ... company cleared to offer this technology to hospitals caring for ...
... OLATHE, Kan., May 21, 2012  BD (Becton, Dickinson and ... medical technology company, and Heart to Heart International, a ... their second joint volunteer initiative to strengthen healthcare in ... the world will build upon the progress made by ...
Cached Medicine Technology:Glytec Adds Pediatric Insulin Dosing to its IV and SubQ FDA Clearances 2BD and Heart to Heart International Collaborate on Second Volunteer Service Trip to Help Improve Healthcare in Haiti 2BD and Heart to Heart International Collaborate on Second Volunteer Service Trip to Help Improve Healthcare in Haiti 3
Transcranial vascular DWL doppler....
... powerful automated system capable of handling any ... user-programmable test protocols to begin a fully ... not included in the comprehensive list of ... the Doppler, PVR and PPG instrument modes. ...
Scoliosis Devices....
The CD Horizon Legacy Spinal System is part of the CD Horizon Spinal System designed for use in small stature patients. The posterior implants (hook and screws) are designed to fit patients in the ra...
Medicine Products: