Reports On Drug Side Effects Are Incomplete

Feb 11, 2015
Paul M. da Costa

A nonprofit group, The Institute for Safe Medication Practices, recently conducted a study on the effectiveness and accuracy of reports made to the Food and Drug Administration regarding side effects of various drugs.  The study found that most reports are “incomplete” and thus, information regarding side effects of many drugs is largely unknown.

Many reports, the study found, did not even include basic information such as the patient’s age or the date of the adverse event.  The lack of complete reporting has left the FDA and consumers unaware of how a particular drug may affect a certain type of individual, for example, older adults.

The study, in particular, focused on reports regarding a drug commonly known for the treatment of hepatitis C.  The study found that basic information regarding the drug’s effects was included in less than 50% of reports made to the FDA by the drug’s manufacturer.  The manufacturer, however, defended its actions by pointing to the fact that in all cases, reports must be turned in on a short deadline and it is often nearly impossible to obtain the necessary information from doctors and consumers to submit a detailed report. 

While there may be somewhat of a chain reaction causing incomplete reports, the FDA expressed interest in improving the reporting system.  Nevertheless, the self-reported nature of the system makes such improvements difficult to enact. 

If you or a loved one suffered adverse effects after taking a prescription drug, you may have a claim against a drug manufacturer.  In order to evaluate your claim, call Paul M. da Costa, Esq. at Sarno da Costa D’Aniello Maceri LLC at 973-274-5200.