Pharma Guidelines Novel Medical Drug Research Pharmaceutical Manufacturing Guidelines

Pharmaceutical Manufacturing Guidelines Latest Updates Novel Medical Drug Research Information on latest Quality Assurance Systems Pharmaceutical Technology Research and Developments FDA updates

Custom Search

Monday, October 24, 2011

Letrozole banned in India for its use to treat infertility as ovulation inducer.

Why and for which indication drug letrozole is bannned in India

The drug letrozole is now banned in India by Indian ministry of health and family welfare for its use to treat infertility in women as it may cause teratogenic effects like defective bone formations, cardiac stenosis and even cancer too, to babies born to mothers who used drug letrozole .

Drug letrozole was approved in India for use as ovulation inducer in women with anovulatory infertility and it is now banned for manufacture for sale, or sale or distribution for indication anovulatory infertility. An official notification with this regard was published in The Gazette of India on 12th of oct 20011

The drug letrozole is banned for its use as ovulation inducer as the drug letrozole has teratogenic effect and may cause defects in babies born to mothers taking drug letrozole. In a clinical trial it was found that the baby born to mothers who had consumed letrozole for treating their infertility have developed bone malformation, cancer and cardiac stenosis.

Letrozole’s use in treatment of breast cancer:
In US the drug letrozole is approved only to treat non metastatic as well as metastatic breast cancer. Breast cancer cells when dislodge form the its origin and when mobilize or spread to other tissue is called as metastatic, and these cancer cells growth is fasten or depends on stimulation from hormone estrogens the female sex hormones.

Estrogens are synthesized in human body from androgens after action of enzyme aromatase.The drug Letrozole competitively blocks enzyme aromatase, thereby blocking the symntesis of estrogens which prevent breast cancer cell from multiplication and further growth.

Though the drug Letrozole is a choice of drug for the indication for breast cancer it has some serious side effects like osteoporosis (loss of bone mass because of which bones become fragile and get fractured more often) and hypoestrogenism, therefore to counter act osteoporosis after use of Letrozole drug like Bisphosphonates are always priscribe along with Letrozole. The drug letrozole is also used off the label by some to counteract gynecomastia induced by anabolic steroids. Now letrozole is banned in India for use as ovulation inducer in women with anovulatory infertility.


You may also like :


US FDA honours woman who rejected thalidomide and saved millions of children's from thalidomide


Microbial load limits for water for pharmaceutical use

Ultraviolet light as antimicrobial disinfectant in water for pharmaceutical use

Why water for pharmaceutical use is always kept in close loop in continuous circulation?

Ion exchange resin and its application in pharmaceutical dosage forms, and drug delivery systems.

Novel Drugs: Cancer Chemotherapy Using Nanoparticles May Reduce Harmful Side Effects.

What is Nanotechnology, its applications in medicine and pharmaceuticals, drug developments?

Good manufacturing practices

Pharma sales jobs Find best pharmaceutical company Job



What is Therapeutic Index ?



What is Narrow Therapeutic Range Drug?


What is High Efficiency Particulate Air( HEPA ) filter ?

What is a Laminar Air Flow Cabinet.

What is an Isolator in pharmaceutical manufacturing.?

What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11?

CFR 21 part 11 and its application on computarised systems used in clinical trials US FDA guidelines

Pharmaceutical Validation

Clean Room Classification


Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---




No comments:

Subscribe to RSS headline updates from:

Contact Form

Name

Email *

Message *