FDA Adverse Effect Reporting System and Why it Doesn't Work
It can be really scary to take a medication and read about the possible dangerous side effects that could happen. However, many times there could be other frightening side effects or harmful drug interactions that weren’t made evident in the pre-market testing. This is why it’s important to report to the FDA if you’re experiencing problems that weren’t listed in the packet that came with your medication. However, reporting drug and device problems to the FDA isn’t an easy process and could be allowing potentially unsafe drugs and medical devices to put others in harm’s way.
What is FAERS?
The FDA is responsible for foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); drugs; vaccines and other biological products; medical devices for humans; radiation-emitting electronic products; cosmetics; dietary supplements, and tobacco products. The FDA Adverse Event Reporting System (FAERS) was designed to help consumers, patients, and doctors make complaints about safety concerns for any one of these products that was approved for the market.
The Problems with FAERS Reports
There are many faulty problems that make these reports inaccurate or that create obstacles for conditions to be reported:
Filling Out a FAERS Report - As a consumer, it can be really confusing and frustrating to fill out a FAERS report. For example, it can be difficult for the average person to know where to find the information needed to just fill out page two of the forms that ask for the maker of the drug, the lot number, the national drug code (NDC), and if the product was compounded.
Overwhelmed, Underfunded FDA - Currently, there are over 8.5 million reports in the system and more are being added everyday. As you can imagine, it is a huge task to sort through all of these reports to find out which are duplicates, which ones are complaining about the original illnesses, if the drug has been warned, and many other factors to consider.
Multiple Names for a Single Drug - Drugs may have multiple brand names, they may go by a generic name, or a combination of drugs can create a new medication name. In fact, it has been estimated that on average, any given drug will have 16 different names in the system. This means that the same drug may cause multiple patients to have a similar condition, but since it may reported under different names, the common side effects may be overlooked.
Slow Results… If Any - A study published in the The Journal of the American Medical Association (JAMA) found that FDA data was seven months behind. “While pharmaceutical companies have a requirement to report adverse event cases to FDA in a timely manner, FDA has no such obligation to release those data to the public in a timely manner… And the second real problem: it takes an average of five full years for the FDA to issue a label change after a safety signal is detected from the FDA Adverse Event Reporting System (FAERS).”
Clearly the FDA and its FAERS reporting system is not effective which is putting the public at risk. It’s time for the FDA to re-evaluate this system to become more efficient and user-friendly.
“Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets”. eLife Sciences. Accessed June 5, 2018. https://elifesciences.org/articles/25818
Cases are now under review, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today before it’s too late.
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