The U.S. Food and Drug Administration (FDA) recently launched a new search
tool that improves access to data on adverse drug events. According to
the agency, the user-friendly tool is designed to make it easier for consumers,
providers, and researchers to access information collected by the FDA
Adverse Event Reporting System (FAERS).
Tracking Adverse Drug Events
Adverse drug events (ADEs), which are defined as harm experienced by a
patient as a result of exposure to a medication, are among the most common
medical mistakes. In total, ADEs account for nearly 700,000 emergency
department visits and 100,000 hospitalizations every year. Nearly five
percent of hospitalized patients experience an ADE, making them one of
the most frequent types of inpatient errors.
The FDA uses FAERS to collect and analyze information on adverse event
and medication error reports submitted to the agency. The database is
part of the FDA's post-marketing safety surveillance program for drug
and therapeutic biologic products. Pharmaceutical companies are required
to submit adverse event reports. However, reporting by health professionals
and patients is voluntary.
The FDA’s new dashboard allows users to search for and organize data
by specified search parameters, such as drug/biological product, age of
the patient, type of adverse event, year the adverse event occurred, or
within a specific timeframe. "Tools like the FDA Adverse Event Reporting
System are critical to the FDA’s ability to help ensure the greatest
level of transparency and help patients and providers make safe use of
drug and biologic products after they are approved by the FDA,"
said FDA Commissioner Scott Gottlieb, M.D. "The FDA is committed to fully informing patients and providers
of adverse events reported with medical products and this enhanced portal
now provides patients, doctors and others with easier access to the data
they are interested in."
The FDA’s adverse event reporting database provides valuable information
and is often used by the agency to detect safety issues. However, it is
important to highlight that FAERS does have limitations. Notably, because
the FDA does not require that a causal relationship between a product
and event be proven, there is no conclusive proof that the product caused
the alleged harm to the patient. In addition, the agency does not receive
reports for every adverse event or medication error that occurs with a product.
While the added transparency is a good first step, we are hopeful that
the FDA also enhances its procedures for post-market surveillance. To
protect patients, it is imperative to track a drug’s safety record
once it is released to the market
and make that information available to the public.
If you or someone you love has suffered serious harm due to a defective
medical device or medication, don’t hesitate to contact
a San Diego product liability lawyer at the Law Offices of Robert Vaage
for a free consultation.