Featured Research

from universities, journals, and other organizations

Initially Recommended Drug Dosages Often Too High, Study Finds

Date:
August 14, 2002
Source:
Georgetown University Medical Center
Summary:
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.

Washington, DC -- 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.

The mission of Georgetown's Center For Drug Development Science is to establish clinical drug development science as a rigorous academic discipline for advancing new scientific methodologies, to contribute to the education of scientists engaged in clinical evaluation of drugs, and to provide solutions to real-world drug development problems. For more information, visit http://cdds.georgetown.edu.


Story Source:

The above story is based on materials provided by Georgetown University Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

Georgetown University Medical Center. "Initially Recommended Drug Dosages Often Too High, Study Finds." ScienceDaily. ScienceDaily, 14 August 2002. <www.sciencedaily.com/releases/2002/08/020814065745.htm>.
Georgetown University Medical Center. (2002, August 14). Initially Recommended Drug Dosages Often Too High, Study Finds. ScienceDaily. Retrieved August 23, 2014 from www.sciencedaily.com/releases/2002/08/020814065745.htm
Georgetown University Medical Center. "Initially Recommended Drug Dosages Often Too High, Study Finds." ScienceDaily. www.sciencedaily.com/releases/2002/08/020814065745.htm (accessed August 23, 2014).

Share This




More Health & Medicine News

Saturday, August 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Drug Used To Treat 'Ebola's Cousin' Shows Promise

Drug Used To Treat 'Ebola's Cousin' Shows Promise

Newsy (Aug. 21, 2014) An experimental drug used to treat Marburg virus in rhesus monkeys could give new insight into a similar treatment for Ebola. Video provided by Newsy
Powered by NewsLook.com
Two US Ebola Patients Leave Hospital Free of the Disease

Two US Ebola Patients Leave Hospital Free of the Disease

AFP (Aug. 21, 2014) Two American missionaries who were sickened with Ebola while working in Liberia and were treated with an experimental drug are doing better and have left the hospital, doctors say on August 21, 2014. Duration: 01:05 Video provided by AFP
Powered by NewsLook.com
Cadavers, a Teen, and a Medical School Dream

Cadavers, a Teen, and a Medical School Dream

AP (Aug. 21, 2014) Contains graphic content. He's only 17. But Johntrell Bowles has wanted to be a doctor from a young age, despite the odds against him. He was recently the youngest participant in a cadaver program at the Indiana University NW medical school. (Aug. 21) Video provided by AP
Powered by NewsLook.com
American Ebola Patients Released: What Cured Them?

American Ebola Patients Released: What Cured Them?

Newsy (Aug. 21, 2014) It's unclear whether the American Ebola patients' recoveries can be attributed to an experimental drug or early detection and good medical care. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins