Tags: drug | maker | side | effects | secret

Drug Makers Keep Some Side Effects Secret: Study

By    |   Tuesday, 03 Feb 2015 04:43 PM

Only about half of reports of serious drug side effects submitted by manufacturers meet basic standards for completeness, according to a new study.

The study, by the nonprofit Institute for Safe Medication Practices, suggests the main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the Food and Drug Administration, The New York Times reports. 
 
The nonprofit group, which tracks drug safety issues, found only about 50 percent of reports of serious side effects submitted by manufacturers met standards, including a patient’s age, sex, and the date the event took place.
 
Reports collected by the FDA, by contrast, were found to meet those basic standards in 85 percent of cases.
 
Drug makers’ reports account for about 97 percent of all adverse events that are collected by the system. The report analyzed more than 847,000 case reports received for the 12-month period that ended in March of 2014.
 
Providing such details can be key to evaluating a drug and how different groups of people might react to it.

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Only half of reports of serious drug side effects submitted by manufacturers meet basic standards for completeness, according to a new study.
drug, maker, side, effects, secret
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2015-43-03
Tuesday, 03 Feb 2015 04:43 PM
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