ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

SURVEY: Cognitive Impairment II

Top 3 Nutrients to Detox the Liver and Soothe Digestion

Natural Bladder Control, Go Less and Live More

Study bodes well for low-carb eaters

Top Vitamin and Mineral Deficiencies — Are You at Risk?

Vital Molecule Increases Cellular Energy and Improves Cognitive Function

Omega Fix for Obesity: How the Right Fats Fight Fat

Potential of Quercetin in the Treatment of Melanoma

How Pomegranate May Protect Against Cancer

Trimming the spare tire: Canola oil may cut belly fat

 
Print Page
Email Article

Study Finds Initially Recommended Drug Dosages Often Too High

  [ 38 votes ]   [ Discuss This Article ]
www.ProHealth.com • August 19, 2002


More than 20% of the drugs approved in the United States are approved at a dosage level that is later discovered to be too high, resulting in the subsequent lowering of the recommended dosage level, according to research conducted at Georgetown University's Center for Drug Development Science (CDDS). Two papers on this subject have been published in the August issue of the British journal Pharmacoepidemiology and Drug Safety.

These dosage changes reveal a discrepancy between the dosage information gathered from pre-marketing studies and that needed for safe and effective use in clinical practice. Avoiding needless overdosing could reduce both side effects and costs of prescription drugs.

In the modern drug development process, great pressure is placed on defining a drug dosage early in the clinical evaluation stage, when information about the drug and its actions is sparse. Ideally, this dosage should remain the same throughout the lifetime of the drug, but the studies published this week indicate that the dosages of cardiovascular and most other classes of drugs are initially overestimated. These overestimated doses are discovered at various times after the drug is introduced into medical practice.

The Georgetown researchers studied the label changes made for all the new drugs approved for use in the United States by the FDA between 1980 and 1999. The team was led by James Cross, MS, regulatory project manager in the FDA's Center for Drug Evaluation and Research (CDER), who was a CDDS research fellow when the research was conducted. They found that dosage changes occurred in 21% of the drugs. Of these, 79% were due to safety concerns. "This pattern may represent a systematic flaw in pre-marketing dosage evaluation," the authors said.

In a separate paper, Dutch researchers from Utrecht University and Maastricht University, observed a similar proportion of dosage changes in drugs introduced in other countries, with the exception of antibiotics, which, according to the data, tend to need increasing doses after market introduction.

Both papers offer several possible reasons for these changes. These include lower doses being tested and found to be as effective subsequent to the drug's approval, changes in regulatory practice, and misjudgements made in the early phases of new drug development. All the researchers agree that further study on the process of dose-selection is needed to ensure that patients get the optimal dose right from the start.






Post a Comment

Featured Products From the ProHealth Store
Vitamin D3 Extreme™ Ultra EPA  - Fish Oil Optimized Curcumin Longvida®


Article Comments



Be the first to comment on this article!

Post a Comment


 
Natural Pain Relief Supplements

Featured Products

Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid

Natural Remedies

The Fast-Acting Solution for Healthy Digestive Function The Fast-Acting Solution for Healthy Digestive Function
Improve Cardiovascular and Metabolic Health with Omega-7 Improve Cardiovascular and Metabolic Health with Omega-7
Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance
Clinically Studied Joint Relief Product for FM & ME/CFS Clinically Studied Joint Relief Product for FM & ME/CFS
Coenzyme Q10 - The Energy Maker Coenzyme Q10 - The Energy Maker

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map