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Major Flaws in Drug Safety Reporting System

prescription drugsThe Institute for Safe Medication Practices (ISMP) has recently issued the results of a study which considered the efficacy of the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) put in place to monitor the safety of medications.

The ISMP notes that they rely on FAERS as a key source of data for their own quarterly reports and thought that it was an appropriate time to shine a spotlight on the source itself.  What they found was that, although FAERS is a crucial system for making available information about the dangers of prescription drugs, it had several flaws that could use attention.

The need to monitor the safety of prescription medications is crucial, as dangerous drug lawyers from The Sanders Firm understand.  Patients have the right to know about potential side effects and risks of pharmaceuticals in a timely manner.  It is in the best interests of all involved parties that accurate information is available and that pharmaceutical companies be held accountable for the safety of their products.

The Sanders Firm shares concerns about drug safety reporting

The ISMP reports that while FAERS may be the best available source for drug safety reporting currently in place, several areas could be improved.

First, there is the matter of “incomplete manufacturer reports.” According to the ISMP study, even basic information about the affected patient is often left out.  They note that “in 36% of cases the age of the patient was not determined; in 44% of cases no event date was indicated.” Moreover, there was a significant disparity between the completeness of adverse event reports sent directly to the FDA, vs. those that were submitted to the manufacturer and passed on to the agency secondhand: “While 85% of serious reports sent directly to the FDA were reasonably complete, only 49.4% of the manufacturer serious reports met this basic standard.”

Second, it is frequently unclear from the data available in the reports whether the drug in question actually caused the adverse event, or whether the two factors were unrelated.  In extreme instances, for example, patients taking medications while suffering life-threatening conditions must have their deaths reported; however, in many cases, the drug in question is not responsible for the death and clear distinctions concerning causation are often omitted from the reports.

“Gaps in system coverage” and “outdated FDA regulations” are additional areas of concern, according to the ISMP study.  Attorneys at The Sanders Firm would welcome revisions and reforms that would provide a more accurate picture of where the dangers in pharmaceutical products actually lie.

How a drug side effects attorney can help you

At The Sanders Firm, we have seen several examples of the real harm that a dangerous drug can do, especially when side effects are not disclosed in a timely manner and patients are not informed of the real risks.  Actos, Benicar, Pradaxa, Xarelto, Risperdal, and testosterone supplements are all examples of medications that, in many cases, caused more harm than good to patients.  For instance, Actos, a diabetes drug, was found to carry an extremely high risk of causing bladder cancer.  Pradaxa and Xarelto are blood thinners with bleeding risks that so far do not have a reversal agent.  And testosterone supplements carry a high risk of cardiovascular injury and stroke among certain populations.

Problematically, patients were unaware of the risks before they took many of these medications.  And, in some cases (as with Actos, for instance) there is strong evidence that pharmaceutical companies were aware of the risks, but chose not to make them known.

If you believe that you or a loved one has been harmed by a dangerous drug, please contact a product liability attorney from The Sanders Firm for a free, no-obligation consultation to understand your legal rights and options.  Please call us at (1-800-324-7752).


  1. ISMP Quarter Watch, A Critique of a Key Drug Safety Reporting System http://www.ismp.org/QuarterWatch/pdfs/2014Q1.pdf 

  2. ABC News, FDA Warns of Bladder Cancer Risk with Actos http://abcnews.go.com/Health/DiabetesTreatment/fda-warns-bladder-cancer-risk-actos/story?id=13850066