FDA System for Recording Adverse Drug Effects Perilously Deficient


The system that the US FDA is using to gather and report on information about dangerous side effects from medications is extremely unreliable and needs a thorough overall, according to a study reported on by the New York Times. The main problem is that drug companies are not submitting their data properly.

“The study, by the Institute for Safe Medication Practices, found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness, containing a patient’s age, sex and the date the event took place. Reports collected by the F.D.A. itself, by contrast, were found to meet those basic standards in 85 percent of cases.”

“The difference is noteworthy because drug makers’ reports account for close to 97 percent of all adverse events that are collected by the system,” continued the Times. “The report analyzed more than 847,000 case reports received for the 12-month period that ended in March of 2014. Providing such details can be key to evaluating a drug and how different groups of people, such as women or older people, might react to it.”

Drug Makers’ Data on Side Effects Is Called Lacking in a Report (New York Times, February 2, 2015)

Also see:

FDA study spanks drugmakers for poor adverse events reporting (FiercePharma, February 3, 2015)

FDA System for Reporting Side Effects Needs a ‘Thorough Overhaul:’ Study (Pharmalot, Wall Street Journal, February 2, 2015)


    • I tried to report adverse effects of the drugs I was on to the FDA, after I’d been weaned off the drugs. I ended being unable to, since the reporting system was tremendously cumbersome. My recollection is you needed actual numbers from the specific bottle of pills to even report and adverse event. And, of course, a person whacked out of their mind on tranquilizers is doing everything they can just to survive at the time they’re on the pills. The bottom line is I’m quite certain the FDA’s
      “System for Recording Adverse Drug Effects [is] Perilously Deficient.”

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      • That is true. I tried to report adverse effects to another agency and my application didn’t get processed at all because I was repeatedly not able to upload a file they needed although the file was the right size and format. I’m starting to think that the side effect reporting tools are so useless for purpose.

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