FDA Requires Boxed Warning for Promethazine Hydrochloride... (r the brand name Phenergan but that form...)

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

Date:9/16/2009

r the brand name Phenergan, but that formulation was discontinued by Wyeth Pharmaceuticals Inc. A number of companies currently market generic formulations of promethazine hydrochloride injection.

The FDA previously informed consumers and health care professionals about the risks of incorrect administration of promethazine in the December 2006 and February 2008 editions of FDA Patient Safety News. Current prescribing information for the drug contains information about the risk of tissue injury, possibly including gangrene, if the drug is inadvertently administered in the artery, but that information was not highlighted in a boxed warning.

Promethazine first went on the market in 1956. FDA has reviewed the published literature and post-marketing adverse event reports submitted to the agency's Adverse Event Reporting System from 1969 to 2009 and identified cases of gangrene requiring amputation associated with administration of the drug.

More information is available in this Information for Healthcare Professionals:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm182169.htm

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2
Related medicine news :

1. To get college students to wash hands requires proper tools, attention-getting tactics
2. Getting College Students To Wash Hands, Halt Disease, Requires Giving Them Proper Tools and Spreading The Word In Ways That Get Attention, Say K-State Expert and Colleague
3. Eliminating polio requires global, coordinated effort -- Health Affairs article highlights risks, rewards of eradication
4. Neuroimaging suggests that truthfulness requires no act of will for honest people
5. THCA on 2009 Legislative Session: Seniors Medicaid-Financed Nursing Home Care Requires Substantially More Investment as Population Ages, Care Needs Grow
6. When Chest Pain Requires Quick Action in ER
7. Using tools requires that the brain is able to control movements
8. Getting Closer to Controlling Cancer Requires Funding More Laboratories and Commitment Beyond Two Years of New Stimulus, Weiner and Berg Assert in Denver Post Oped
9. Poison Prevention Requires Diligence
10. Recession-resistant Marketing Requires Innovative Steps
11. Stimulus Bill Requires Modification in U.S. Senate to Better Protect Seniors Ongoing Access to Quality Nursing Home Care

Post Your Comments:

(Date:7/29/2010)... HealthDay Reporter , , THURSDAY, July 29 (HealthDay News) -- ... a better predictor of how well a woman will ... been the traditional way of looking at cancers, new ... the genetic makeup of 595 breast cancer tumors and ... used algorithms to separate the tumors into eight types ...

(Date:7/29/2010)... Administration (FDA) received reports of malignancies in children using ... an associated risk and prompting an investigation. Researchers from ... malignancy in children using infliximab, etanercept, and adalimumab and ... Arthritis & Rheumatism , a journal of the ... approved 3 TNF blockers for use in children: Etanercept ...

(Date:7/29/2010)... , , THURSDAY, July 29 (HealthDay News) -- New research ... the risk of broken bones in postmenopausal women with ... risk seen among men who had been prescribed either ... isn,t the first time such an association has been ... belong to the class of medications known as thiazolidinediones ...

(Date:7/29/2010)... history of male breast cancer perceive themselves to be at ... a family history of female breast cancer; however those with ... know about or seek genetic testing than those with a ... led by researchers at the University of Louisville,s James Graham ... accounts for only about one percent of all breast cancers, ...

(Date:7/29/2010)... new study from Perth,s Telethon Institute for Child Health ... diet in adolescents. , The research findings have just ... Attention Disorders . , Leader of Nutrition studies at ... examined the dietary patterns of 1800 adolescents from the ... ,Western, patterns. , "We found a diet high ...

Breaking Medicine News(10 mins):Health News:Breast Cancer's DNA Yields More Secrets 2 Health News:Breast Cancer's DNA Yields More Secrets 3 Health News:TNF blockers may increase the risk of malignancy in children 2 Health News:TNF blockers may increase the risk of malignancy in children 3 Health News:New Data Supports Link Between Diabetes Drugs, Fractures 2 Health News:New Data Supports Link Between Diabetes Drugs, Fractures 3 Health News:Male breast cancer in family leads to high perception of risk, low likelihood of genetic counseling 2 Health News:Male breast cancer in family leads to high perception of risk, low likelihood of genetic counseling 3 Health News:Western diet link to ADHD 2

[1] Breast Cancer's DNA Yields More Secrets [0] TNF blockers may increase the risk of malignancy in children [0] New Data Supports Link Between Diabetes Drugs, Fractures [0] Male breast cancer in family leads to high perception of risk, low likelihood of genetic counseling [0] Western diet link to ADHD

... June 15, 2006 issue of CANCER, a peer-reviewed journal ... radiation// could be a treatment option for men aged ... ,Age has remained a controversial factor, which dictates ... recommend more aggressive therapy as compared to older individuals. ...

... is a generally accepted fact that the doses given ... it is not always clear, how much is enough ... Children’s Center shows that making the dosage a computerized ... well. ,An online infusion calculator and a ...

... leading cardinal has urged Christians to initiate legal action against ... he feels that it offends Christ// and the Church as ... it is enough for us to forgive and to forget,' ... attempts to disclose a murder mystery associated with the life ...

... remembered of the 90 million odd volunteers belonging to the ... back bone of the movement//, and whose helping hand is ... needy all over the world. , ,These unsung heroes ... risking their lives at times, in order to help others ...

... die every day in Madhya Pradesh due to pregnancy related complications, ... ,According to data from the National Family Health Survey (NFHS), the ... which means that out of every 100,000 women, 498 die either ... mother. ,Taking the Census figures, about 1.9 million ...

... apply for a separate insurance scheme as they would no ... may feel that they can go without insurance to save ... or diagnosed with a serious medical problem. Even those ... a few months since there's often a waiting period before ...

Other Medicine News:Health News:Dispensing Drug Dosage To Children Through Computers 2 Health News:Dispensing Drug Dosage To Children Through Computers 3 Health News:Dispensing Drug Dosage To Children Through Computers 4 Health News:Salutations For The Selfless Heroes On World Red Cross Day 2 Health News:At Least 25 Women Die Of Maternity Complications In MP Everyday 2 Health News:Insurance Plans after Graduation 2

Radiation Therapy Benefits Younger Men With Localized Prostate Cancer Dispensing Drug Dosage To Children Through Computers Cardinal Calls For Legal Response Against 'Da Vinci Code'Salutations For The Selfless Heroes On World Red Cross Day At Least 25 Women Die Of Maternity Complications In MP Everyday Insurance Plans after Graduation

(Date:7/28/2010)... Matrixx Initiatives, Inc. (Nasdaq: MTXX ), an over-the-counter ... first quarter ended June 30, 2010 , will be released ... An earnings conference call will be held the following morning on ... . , , , ... access the teleconference, please call (888) 287-5536 (domestic) or (719) 325-2332 ...

(Date:7/28/2010)... DURECT Corporation (Nasdaq: DRRX ) announced today that ... Capital Markets 10th Annual Focus on Healthcare Conference on Thursday, August 5 ... at the Sheraton New York Hotel. , ... (Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO ) , , ... http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO ) , , , ...

(Date:7/28/2010)... , July 28 Dr. Michael Klein , ... how FDA works with other entities to confront and to prevent misuse ... , , ... , , ... , , ...

Breaking Medicine Technology:Matrixx Initiatives, Inc. Sets Time for Discussion of Fiscal 2011 First Quarter Financial Results 2 DURECT to Present at the BMO Capital Markets Focus on Healthcare Conference 2 FDA CONSUMER HEALTH INFORMATION - Combating Misuse and Abuse of Prescription Drugs: Q&A with Michael Klein, Ph.D. 2 Information about the use and accuracy of breast cancer tests is lacking study finds 56994 1 Information about the use and accuracy of breast cancer tests is lacking study finds 56994 2 Nektar Presents Data Demonstrating Favorable Oral Bioavailability and Drug Drug Interaction Profile for NKTR 118 4985 1 Nektar Presents Data Demonstrating Favorable Oral Bioavailability and Drug Drug Interaction Profile for NKTR 118 4985 2 Nektar Presents Data Demonstrating Favorable Oral Bioavailability and Drug Drug Interaction Profile for NKTR 118 4985 3 Nektar Presents Data Demonstrating Favorable Oral Bioavailability and Drug Drug Interaction Profile for NKTR 118 4985 4 Nektar Presents Data Demonstrating Favorable Oral Bioavailability and Drug Drug Interaction Profile for NKTR 118 4985 5 Nektar Presents Data Demonstrating Favorable Oral Bioavailability and Drug Drug Interaction Profile for NKTR 118 4985 6 Two New Studies Report Increased Survival Rates in Tamiflu 28R 29 Treated Patients with Avian Flu 28H5N1 29 and Severe Seasonal Flu 4983 1 Two New Studies Report Increased Survival Rates in Tamiflu 28R 29 Treated Patients with Avian Flu 28H5N1 29 and Severe Seasonal Flu 4983 2 Two New Studies Report Increased Survival Rates in Tamiflu 28R 29 Treated Patients with Avian Flu 28H5N1 29 and Severe Seasonal Flu 4983 3 Two New Studies Report Increased Survival Rates in Tamiflu 28R 29 Treated Patients with Avian Flu 28H5N1 29 and Severe Seasonal Flu 4983 4 Two New Studies Report Increased Survival Rates in Tamiflu 28R 29 Treated Patients with Avian Flu 28H5N1 29 and Severe Seasonal Flu 4983 5

[0] Matrixx Initiatives, Inc. Sets Time for Discussion of Fiscal 2011 First Quarter Financial Results [0] DURECT to Present at the BMO Capital Markets Focus on Healthcare Conference [0] FDA CONSUMER HEALTH INFORMATION - Combating Misuse and Abuse of Prescription Drugs: Q&A with Michael Klein, Ph.D.

... Healthpoint today announced,that it has initiated a clinical ... enzymatic debriding agent on healing cutaneous wounds and,resulting ... by clinical reports,of the reduced incidence of hypertrophic ... Ointment.(1,2), "Given the findings from the peer-reviewed ...

... Potential to ... Preparedness, ROCKVILLE, Md., Aug. 26 Novavax, Inc.,(Nasdaq: ... of,the Phase I/IIa human clinical trial of its pandemic influenza ... an,adjuvant, induced robust neutralizing antibody responses. Novavax,s VLP,candidate is directed ...

Other Medicine Technology:Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing 2 Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing 3 Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program 2 Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program 3 Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program 4 Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program 5 Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program 6

Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program

Eschenbach's new 2636 series of stand magnifiers delivers the benefits of high power and a large fields of view. Using a unique doublet lens design, the 2636 offers the highest power recatngular lens...

The Multi-Purpose Stand Magnifier is the most versatile stand magnifier. The stand has multiple configurations allowing for all situations where hands-free magnification is needed....

Bausch & Lomb magnifiers incorporates precision optics and patented ergonomic designs for increased clarity and comfort during use....

Bausch & Lomb round and rectangular magnifiers incorporate precision optics and an ergonomic design for increased clarity and comfort during use...

Medicine Products:

Stand Magnifiers Multi-Purpose Stand Magnifier 2" x 4" Rectangular Magnifier 3 1/4" Round Magnifier

FDA Requires Boxed Warning for Promethazine Hydrochloride...(r the brand name Phenergan but that form...),Health