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

p>

"There are now three products approved in the U.S., each with different units, and the units cannot be interchanged," Unger said. "Switching patients from one to another runs the risk of underdosing or, more important, overdosing."

The three approved products are Botox, Myobloc and Dysport, which was approved this week. Officials said there have been no post-marketing reports of similar problems with the newest drug.

The injections, which temporarily "paralyze" muscles, are intended to have a localized effect but can pose problems if the compound spreads to other parts of the body.

"When given in a particular place, they spread locally, meaning they move into adjacent structures," Unger explained. "We have known that for years, and it can be annoying and somewhat of a significant problem for given patients but does not result in disability or harm."

"The real concern is when there is distant spread," he said. "It is injected at one point and spreads to areas not adjacent."

The FDA issued an "early communication" in February 2008, warning of these adverse reactions. The month before, the watchdog group Public Citizen petitioned the agency to add a black-box warning to the two drugs then on the market in the United States, describing 180 "adverse event cases" related to the drugs, including 16 deaths, four in people younger than 18.

Between early 2008 and now, the FDA became "more certain about the cases," Unger said. "We felt we really needed to nail down the scope of the problem before we placed a boxed warning, which is something we take very seriously."

The FDA will also require manufacturers to put in place what it calls a risk evaluation and mitigation strategy -- in essence, a comprehensive patient safety guide.

"Updating labeling will help patients and health-care professionals better understand the risks and benefits," Unger said. "These drugs have benefits, but they als
'/>"/>

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:1/22/2015)... Padre Murphy's and Owner Tom Boyle in Glendale, ... Health Alliance (PPHA). The PPHA's passion for others' well-being ... NFL greats, treated for obstructive sleep apnea (OSA) has propelled ... cause in the valley. The most recent plans for an ...
(Date:1/22/2015)... Minn. (PRWEB) January 22, 2015 Blue Cross ... those Minnesotans who exemplify what it means to “Live Fearless.” ... chance for people to share their stories about how they ... or simply inspired others by living in the moment. By ...
(Date:1/22/2015)... 22, 2015 A new white paper ... and person-centeredness in the long-term care environment as well ... the continuum. The paper, “The Power of Person-Centeredness in ... and practices of the patient, resident and family experience ...
(Date:1/22/2015)... Carinsurancesavings.biz has released a new blog post presenting the basic ... , Purchasing an accidental death and dismemberment rider for a ... rider provides benefits if the insured dies in an accident. ... of life insurance. , AD&D is not expensive and ...
(Date:1/22/2015)... January 23, 2015 Recently, Weddingshe.com has added ... and has announced its highest annual revenues in the past ... its popular glamorous wedding dresses. , According to the sales ... wedding dress promotions for them in 2015. This point can ...
Breaking Medicine News(10 mins):Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 2Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 3Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2
... (HealthDay News) -- ,People with a sense of entitlement are more ... which makes it feel like time is passing slowly while they ... study by University of Michigan researchers who conducted a series of ... are owed something without necessarily putting in effort to attain it," ...
... SUNDAY, Oct. 9 (HealthDay News) -- Children are four times ... night than on any other night of the year, according ... Prevention. In addition, the researchers warned that eye ... also common Halloween injuries. "Children should be out having ...
... 10, 2011 The National Cancer Institute (NCI) has ... Hospital System as a national site to improve screening ... The five-year, $6.3 million NCI grant establishes the ... network for colorectal cancer screening. The UT Southwestern-Parkland partnership, ...
... FRIDAY, Oct. 7 (HealthDay News) -- ,Septicemia was the ... 2009, with a cost of about $15.4 billion, according ... life-threatening illness caused by blood infections with bacteria such ... The analysis of national data also showed that the ...
... HealthDay Reporter , FRIDAY, Oct. 7 (HealthDay News) ... linked to tainted cantaloupes has risen to 21, and a ... the U.S. Centers for Disease Control and Prevention reported late ... in question were recalled Sept. 14, more cases might still ...
... , FRIDAY, Oct. 7 (HealthDay News) -- A community-based ... smoking, drinking, violence and other bad behavior, according to ... helps communities choose programs that have been shown to ... was developed by University of Washington researchers, who conducted ...
Cached Medicine News:Health News:Dull Tasks Tougher on the Entitled 2Health News:Number of U.S. Kids Injured on Halloween Is Scary 2Health News:UT Southwestern, Parkland partner for $6.3 million NCI grant to improve colorectal cancer screenings 2Health News:UT Southwestern, Parkland partner for $6.3 million NCI grant to improve colorectal cancer screenings 3Health News:21 Deaths From Cantaloupe-Linked Listeria Outbreak: CDC 2Health News:21 Deaths From Cantaloupe-Linked Listeria Outbreak: CDC 3Health News:Community-Wide Effort May Help Tame Troubled Teens 2
(Date:1/23/2015)... , Jan. 23, 2015 Tianyin Pharmaceutical Inc. (NYSE ... specializes in the development and sale of patented biopharmaceutical ... active pharmaceutical ingredients (API) today announced the business and ... operation. 1. Following the September 2014 JCM ...
(Date:1/22/2015)... Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), a specialty ... disease and overall health is pleased to provide you with ... outlook for 2015 from the CEO, Mr. Eugene Bortoluzzi ... like to take this opportunity to share with you the ...
(Date:1/22/2015)... , Jan. 22, 2015 Research and Markets ... the "Infectious Disease Diagnostics Market by Product, Application, ... report to their offering. , The infectious ... of 7.9% to reach $18,156.2 million by 2019 from ...
Breaking Medicine Technology:TPI's JCM Updates on Import Registration for International Clients 2TPI's JCM Updates on Import Registration for International Clients 3TPI's JCM Updates on Import Registration for International Clients 4Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7Global Infectious Disease Diagnostics (Instruments, Reagents, Services, Software) Market - Forecast to 2019 2Global Infectious Disease Diagnostics (Instruments, Reagents, Services, Software) Market - Forecast to 2019 3
... NEW ORLEANS , May 3 ... developing novel catheter-mounted digital imaging devices, today announced five ... Retroscope® during colonoscopy procedures increases detection of adenomas and ... years of experience, were able to detect adenomas of ...
... Questcor Pharmaceuticals, Inc . (Nasdaq: QCOR ) today announced that it will ... Panel meeting on Monday, May 10, 2010 at ... Don Bailey , President and Chief Executive Officer; Steve Cartt ... Chief Science Officer; and Dr. Jason Zielonka , Senior Vice President and ...
Cached Medicine Technology:Third Eye(R) Retroscope(R) Demonstrates Improved Adenoma Detection 2Third Eye(R) Retroscope(R) Demonstrates Improved Adenoma Detection 3Third Eye(R) Retroscope(R) Demonstrates Improved Adenoma Detection 4Third Eye(R) Retroscope(R) Demonstrates Improved Adenoma Detection 5Third Eye(R) Retroscope(R) Demonstrates Improved Adenoma Detection 6Questcor to Discuss Results From FDA Panel Meeting 2
For the quantitative determination of uric acid in serum....
The assay kit is for determination of uric acid in serum or urine. Wavelength: 600 nm. Linear range: up to 80 mg/dL....
For the quantitative determination of Uric Acid in serum. Linearity: 25 mg/dl....
... A fully automated, random ... over 50 assays available ... tumor marker, therapeutic drug, ... testing can be performed ...
Medicine Products: