AdverseEvents Reports On FDA Approved Drug Side Effects

AdverseEvents, a drug safety analysis company, has released a report detailing side effect reports for Food and Drug Administration (FDA) approved drugs. The report cites the importance of recognizing side effect reports as a public safety issue. The study authors state that pre-approval studies are insufficient, clinical trials can never be big enough, and characterizing all side effects prior to drug marketing is unlikely. Any drug has the potential to trigger a side effect after FDA approval. Therefore, monitoring drugs after their approval is critical to the drug’s safety profile.

In the report, interested parties can discover how clinical trials are insufficient in predicting side effects. The report explains how post-approval data is gathered and how healthcare providers have insufficient resources to discover side effects. The white paper authors provide action steps to improve data gathering on side effects.

The FDA has reporting portals for consumers and medical professionals to register adverse drug events. MedWatch is the online portal, but people can call or email reports. With over 4,000 approved drugs, the FDA receives about 800,000 Adverse Drug Events (ADEs) each year. While most patients take their medications and experience side effects at home, about seven percent of adverse events happen in the hospital. These ADEs cause fatalities, putting them in the top five leading causes of death in the U.S.

Clinical Trials are Insufficient

This report explains how clinical trials are insufficient for predicting side effects. Pharmaceutical companies are interested in clinical trials that show the efficacy of the drug. Therefore, participants are enrolled that are most likely to improve by using the drug being studied. The clinical trial enrollees are much like those selected by attorneys for jury duty, carefully selected to produce the desired outcome. This group may produce positive results, but the group is homogeneous. When the drug reaches a heterogeneous population, results may differ dramatically.

The FDA acknowledges this discrepancy, noting that a complete drug profile is unknown at the time of approval due to short trial times, small sample size, and limited diversity in enrollees. Additionally, most studies exclude children, older people, pregnant women, and those with multiple health issues. 

AdverseEvents recommends improvements in collecting and organizing post-approval side effect reports, empowering health care providers to collect data, relating side effects to medical costs, and using the improved data to make better predictions about drug safety. 

Source:

http://www.adverseevents.com/post-fda-approval-safety/?utm_source=homepage&utm_medium=Homepage