In 2011 this blog was listed as one of the top 10 blog in pharma technical information it is popular amongst the pharmacists and pharma industry professionals. We have published very important and very useful information for pharma industry professionals.

Sunday, September 19, 2010

Drug Actos pioglitazone bladder cancer risk

US FDA is reviewing preliminary safety information about Drug Actos (pioglitazone) for possible association with risk of bladder cancer.

The United States. F D A on 17-SEP-2010 has made an announcement that they are reviewing preliminary safety information about Drug Actos (pioglitazone) a anti diabetes drug .

FDA is reviewing safety as it is reported that the drug may be associated with risk of bladder cancer, after receiving preliminary results from a long-term observational study designed to evaluate the use of this drug.

FDA states in their press release that the preliminary results are based up on ongoing, 10-year observational study by the pharmaceutical manufacturer, Takeda Pharmaceuticals, an North America Inc., San Diego. and the data collected is five-year data .

Early results did not showed any association of Drug Actos (pioglitazone) exposure and and risk of bladder cancer. How ever it is being evaluated by FDA for possibilities association with risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug .

FDA stated in their press release that they have not yet concluded that Actos increases the risk of bladder cancer.

Information about Actos (pioglitazone)



It is a anti diabetic drug belonging to the class thiazolidinedione (TZD) drugs known as peroxisome proliferator-activated receptor (PPAR) agonists.Drug Actos (pioglitazone) currently is in use to control blood sugar level in patients suffering from Type II diabetes mellitus.

Pioglitazone stimulates the nuclear receptor peroxisome proliferator-activated receptor gamma (PPAR-γ) , PPAR-α , there by enhancing the trascription of insuline sensitive genes responsible for glucose and lipid metabolism taking place in adipose and musclular tissue and in liver , as a result pioglitazone reduces the resistance of insulin in periferal tissue and liver. Drug Avandia (rosiglitazone) is the other only one drug that also belongs to class of drug peroxisome proliferator-activated receptor (PPAR) agonists.

FDA stated in press release that they don’t have any clinical information associating other drug Avandia with bladder cancer in patients receiving that drug.

As US FDA has not concluded the result of review of the association between use of Actos (pioglitazone) and increased risk of bladder cancer. FDA has asked patients to talk to their health care professional, and they should not stop taking the drug unless asked to do so by their health care professional.

=====================================================================================================
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.
=====================================================================================================

No comments:


What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.

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