About My Health Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

Less Patients Available to Evaluate Medicines for Chronic Use

by Bidita Debnath on March 22, 2013 at 5:04 PM
Font : A-A+

 Less Patients Available to Evaluate Medicines for Chronic Use

To properly evaluate safety and long-term efficacy, requiring the need for new legislation for medicines intended for chronic use, the number of patients studied before regulatory approval is insufficient.

This is according to a study by European researchers published in this week's PLOS Medicine.

Advertisement

Current European guidelines specify that in order to fully evaluate the safety of medicines being developed for chronic (long-term) treatment of non-life threatening diseases, at least 1000 patients must take the new drug and that 300 and 100 patients must use the drug for 6 and 12 months, respectively, before approval by the European Medicines Agency.

In an analysis led by Ruben Duijnhoven from Utrecht University, the authors used information from the European Commission about 200 medicines approved between 2000 and 2010 to investigate whether the number of patients included were in compliance with the International Conference on Harmonisation E1 guidelines.
Advertisement

The authors found that the average number of patients studied before approval was 1708 for standard medicines and 438 for orphan medicines, medicines used to treat rare diseases. On average, medicines for chronic use (for example, asthma medications) were studied in more patients (2338) than those for intermediate use such as anti-cancer drugs (878) or short-term use such as antibiotics (1315). The safety and efficacy of chronic use was studied in fewer than 1000 patients for at least 6 and 12 months in 46.4% and 58.3% of new medicines, respectively. Finally, the authors found that among the 84 medicines intended for chronic use, 69 were studied in at least 300 patients for 6 months and 67 were studied in at least 100 patients for 12 months.

The authors say: "For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy. Both safety and efficacy require continued study after approval."

They conclude: "In light of new scientific and legislative tools to monitor benefits and risks in clinical use, discussion of the long-term exposure requirements for approval of medicines, particularly for medicines intended for chronic use, seems warranted."

The authors add: "Such a discussion should involve healthcare providers, patients and academia as well as industry and regulators and should include debate on the level of acceptable uncertainty especially for adverse events and the long-term outcomes for chronic medication."

Source: Eurekalert
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Advertisement
News Category
What's New on Medindia
Cervical Cancer Awareness Month 2022
Ultra-Low-Fat Diet
Goji Berries May Protect Against Age-Related Vision Loss
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Drug Toxicity 

Recommended Reading
Tinnitus Symptom Evaluation
Tinnitus is a ringing or a swishing noise that emanates from the ear or head. It is not a ......
Using Pro-Resolving Nanomedicines for Clearing Up Inflammation
A natural defense mechanism against invading organisms and tissue injury is inflammation....
Interpol Announces Deal With Pharma Companies to Fight Fake Medicines
A deal with the world's top drug firms to fight fake medicines which threaten the health of ......
New Regulations Required For 'Growing' Medicines in Plants
Amending an EU directive on GMOs could help stimulate innovation in making vaccines, cheaper ......
Drug Toxicity
Drug toxicity is an adverse reaction of the body towards a drug that results as a side effect of a d...

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2022

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use
open close
CONSULT A DOCTOR
I have read and I do accept terms of use - Telemedicine

Advantage Medindia: FREE subscription for 'Personalised Health & Wellness website with consultation' (Value Rs.300/-)