Drug propoxyphene brand name drugs (Darvon and Darvocet) and its all generic versions set for complete removal from US market following US FDA’S request.
Xanodyne Pharmaceuticals Inc. manufacturer of drug Darvon and Darvocet (brand name drugs) containing propoxyphene (a drug used for reliving pain ) and its all generic versions are all set to withdraw the drug from the U.S. market after the request from the U.S. Food and Drug Administration. Xanodyne Pharmaceuticals Inc and manufacturers of generic versions of propoxyphene containing drugs are also been informed to withdrawal of their respective drugs voluntarily from us market by The US FDA.
Why the drugs containg propoxyphene are being withdrawen from US market.
Propoxyphene (Dextropropoxyphene) is an opoid analgesic which was being used to treat mild to moderate pain, it was observed that patients taking drug were at high risk of getting potentially serious cardiac events, like fatal heart rhythm abnormalities, even at a regular recommended doses of propoxyphene brings about significant changes in the electrical activity of the heart. These changes, are reflected well in an electrocardiogram (ECG), these changes in electrical activity of heart increases the risk of serious and abnormal heart rhythms which are linked to serious adverse effects, including sudden death, even the patients taking drug for many years are subjected to the change in cardiac electrical activity with small change in the heath condition, like dehydration , a change in other medications and decreased renal function.
Propoxyphene is also known to cause dependency in users.
Looking at these facts in July 2009 the US FDA had asked Xanodyne Pharmaceuticals Inc to conduct additional safety studies besides the clinical trial data which was already submitted at the time of approval .
After reviewing these post market afety studies the US FDA has concluded that the beneficial effects of drugs containing Propoxyphene do not overweigh the risks of developing serious cardiac events, heart rhythm and abnormalities. As a result of review of the data, combined with other information, including new epidemiological data US FDA has asked to remove these drugs from US market.
Drugs containg propoxyphene were approved fist in 1957 by US FDA as a prescription.It was also combined with aspirin and acetaminophen (paracetamol).
US FDA has also advised health care professionals for not to prescribe drugs containing propoxyphene , the patients taking drug propoxyphene should contact their doctor /health care professional as soon as possible for changing the drug with other pain reliving drugs in for their therapy. How ever these effect are not cumulative, and are subsidized after discontinuation of the drug.
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Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.
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Xanodyne Pharmaceuticals Inc. manufacturer of drug Darvon and Darvocet (brand name drugs) containing propoxyphene (a drug used for reliving pain ) and its all generic versions are all set to withdraw the drug from the U.S. market after the request from the U.S. Food and Drug Administration. Xanodyne Pharmaceuticals Inc and manufacturers of generic versions of propoxyphene containing drugs are also been informed to withdrawal of their respective drugs voluntarily from us market by The US FDA.
Why the drugs containg propoxyphene are being withdrawen from US market.
Propoxyphene (Dextropropoxyphene) is an opoid analgesic which was being used to treat mild to moderate pain, it was observed that patients taking drug were at high risk of getting potentially serious cardiac events, like fatal heart rhythm abnormalities, even at a regular recommended doses of propoxyphene brings about significant changes in the electrical activity of the heart. These changes, are reflected well in an electrocardiogram (ECG), these changes in electrical activity of heart increases the risk of serious and abnormal heart rhythms which are linked to serious adverse effects, including sudden death, even the patients taking drug for many years are subjected to the change in cardiac electrical activity with small change in the heath condition, like dehydration , a change in other medications and decreased renal function.
Propoxyphene is also known to cause dependency in users.
Looking at these facts in July 2009 the US FDA had asked Xanodyne Pharmaceuticals Inc to conduct additional safety studies besides the clinical trial data which was already submitted at the time of approval .
After reviewing these post market afety studies the US FDA has concluded that the beneficial effects of drugs containing Propoxyphene do not overweigh the risks of developing serious cardiac events, heart rhythm and abnormalities. As a result of review of the data, combined with other information, including new epidemiological data US FDA has asked to remove these drugs from US market.
Drugs containg propoxyphene were approved fist in 1957 by US FDA as a prescription.It was also combined with aspirin and acetaminophen (paracetamol).
US FDA has also advised health care professionals for not to prescribe drugs containing propoxyphene , the patients taking drug propoxyphene should contact their doctor /health care professional as soon as possible for changing the drug with other pain reliving drugs in for their therapy. How ever these effect are not cumulative, and are subsidized after discontinuation of the drug.
=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.
=====================================================================================================
You may also like following articles
What is a Site Master file of a pharmaceutical company
What is Generic Drug
What is Reference Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
What are Post Market studies
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic Resistance and Antibiotic resistance mechanism
Antioxidants food supplements
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Clean Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry
Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
Quality assurance in pharma industry
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Quality by design concept in pharmaceutical industryan explanation
Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals
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