Max
09-09-2002, 12:49 PM
Drugged Out
Mon Sep 9, 2:05 PM ET
MONDAY, Sept. 9 (HealthScoutNews) -- You might be getting a government-approved "high."
More than 20 percent of the drugs approved in the United States are approved at too high a dosage level, and those dosages have to be subsequently lowered, say researchers at Georgetown University's Center for Drug Development Science.
Their findings appear in a recent issue of Pharmacoepidemiology and Drug Safety.
The dosage changes required after approval show there's a discrepancy between dosage data gathered from pre-marketing studies and data required for safe and effective clinical use, the study authors say. Reducing this kind of approved drug overdosing could reduce side effects and prescription drug costs, they add.
The Georgetown researchers examined label changes made for all new drugs approved in the United States between 1980 and 1999. They found dosage changes were made in 21 percent of the drugs. Of those changes, 79 percent were the result of safety concerns.
"This pattern may represent a systematic flaw in pre-marketing dosage evaluation," the authors write.
Ideally, the dosage of a drug should remain constant through its lifetime of use.
Another study by Dutch researchers found a similar rate of dosage changes in drugs approved in other countries, with the exception of antibiotics.
More information
The U.S. Food and Drug Administration ( news - web sites) has more on the safe use of medicines.
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"Experience teaches that, of all the emotions, fear stands alone in its power to move us, or to capture us in its grip forever. In a world of terrors, there is nothing more fearsome that the unknown...especially when what is unknown is ourselves." Outer Limits(Fear Itself)
Mon Sep 9, 2:05 PM ET
MONDAY, Sept. 9 (HealthScoutNews) -- You might be getting a government-approved "high."
More than 20 percent of the drugs approved in the United States are approved at too high a dosage level, and those dosages have to be subsequently lowered, say researchers at Georgetown University's Center for Drug Development Science.
Their findings appear in a recent issue of Pharmacoepidemiology and Drug Safety.
The dosage changes required after approval show there's a discrepancy between dosage data gathered from pre-marketing studies and data required for safe and effective clinical use, the study authors say. Reducing this kind of approved drug overdosing could reduce side effects and prescription drug costs, they add.
The Georgetown researchers examined label changes made for all new drugs approved in the United States between 1980 and 1999. They found dosage changes were made in 21 percent of the drugs. Of those changes, 79 percent were the result of safety concerns.
"This pattern may represent a systematic flaw in pre-marketing dosage evaluation," the authors write.
Ideally, the dosage of a drug should remain constant through its lifetime of use.
Another study by Dutch researchers found a similar rate of dosage changes in drugs approved in other countries, with the exception of antibiotics.
More information
The U.S. Food and Drug Administration ( news - web sites) has more on the safe use of medicines.
==============================
"Experience teaches that, of all the emotions, fear stands alone in its power to move us, or to capture us in its grip forever. In a world of terrors, there is nothing more fearsome that the unknown...especially when what is unknown is ourselves." Outer Limits(Fear Itself)