The FDA has been collecting information about adverse events associated with approved drugs since 1969 as part of its post-approval safety surveillance program. The "Medwatch" initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners. In 2013, user-friendly online reporting forms for consumers (Form 3500B) and for healthcare professionals (Form 3500) were launched on the FDA web site.
These forms are still used today, with a few changes (such as
adding "gender" in addition to "sex at birth" items) to the form
appearing in 2022.
FDA Adverse Events Reporting System (FAERS)
If healthcare professionals or consumers report drug and biological product adverse events directly to the pharmaceutical company, then the company is required by law to send a report about the event to the FDA. Because this is mandatory, it is not part of the "Medwatch" program but is part of the "FDA Adverse Events Reporting System" (FAERS). This chart (see FDA's 50-state meeting in resources listed below for source) shows the data flow from the patient, physician or healthcare practitioner, and pharmaceutical companies to the FAERS database:
How quickly the drug company has to file the report with the FDA depends upon how serious and how unusual the adverse event. According to FDA guidelines, "reports of serious adverse experiences that are not listed in the product's current labeling must be reported within 15 calendar days of the initial receipt of the information by the applicant." Other reports may take a long time to make their way to the FDA: non-serious adverse experiences or serious adverse experiences that are already included in the product's current labeling must be submitted by the company's regular due date for the reports, which is either quarterly or annually.
The FAERS database contains more than 29 million reports as of August
2024. In 2023, 2.16 million reports
were received, while in 2015, 1.7 million reports were received.
In 2005 only about 320 thousand reports were recieved. The chart below shows the steep increase in the number of adverse event reports filed between 1970 and the present.
The vast majority, about 97%, of the drug reports in FAERS come from industry (about 600 companies) and only about
3% in recent years come directly from the public (including patients or their family member, and physicians or other healthcare providers).
We (AskaPatient) asked the FDA why there has been an exponential
increase in company-reported adverse events over the years, but
not a proportional increase in consumer-reported adverse effects
directly reported through the MedWatch program. They didn't have
an answer to that question.
One thing that might be confusing and dissuading consumers from
using the form 3500-B MedWatch reporting form is the confusing options on
the form itself. In the "consumer-friendly" version of the form,
it tells you to go to Section C to report a problem with a
prescription or over-the-counter-drug:
But when you do go to section C, these are the only options for the type of product you are reporting on. Perhaps consumers are confused that there is no checkbox for medicines and either don't report it or call the manufacturer instead.
Form images source: FDA MedWatch Form
How do the reports affect drug safety?
The FDA says that if analysis of the reports indicates that there is a new safety issue that is not already listed on the current drug label, it will trigger a warning to the FDA and the pharmaceutical company. Most frequently, the company will have to make a change to the drug label, with FDA sometimes releasing a communications notification about of the new side effect warning or change in dosage or indication recommendations. Sometimes, a "black box" warning will be issued for the drug (this warning also will be printed prominently on the drug label). Less occasionally, the FDA will require the drug company to undertake a study related to the adverse event of concern. Or, the FDA might use its own clinical pharmacologists to analyze the medicine. Very rarely, the drug will be "voluntarily" (at the strong suggestion of the FDA) withdrawn from the market.
The FDA keeps a list of drugs on its "radar" that it is
monitoring for safety reasons. This list, called "Potential
Signals of Serious Risks: New Safety Information Identified by
the FA Adverse Reporting System (FAERS) is updated quarterly.So
far, 30 entries have been added in 2024, for either individual
drugs or product classes or categories. The FDA notes what the
potential risk is and what has been done about it or whether it
is "evaluating the need" for regulatory action. Check it out
here:
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event-reporting-system
The FDA has issued around 221 drug safety alerts, including withdrawals and
recalls, between January 2018 and August 2024. (Check here for the
sortable list.) Note that 101 of them have been terminated. Also, the FDA
publishes annual lists of drug safety communications, which are for important safety news announcements. The number of these communiations are fairly few and far between. So far in 2024, only one has been issued,
for
Prolia osteoporosis drug, regarding a risk of hypocalcemia (very low blood
calcium levels) for certain patients. In 2023, just three were issued, five in 2022, 8 in 2021, 10 in 2020, 9 in 2019, 14 in 2018, and 12 in 2017. The list from 2018 includes warnings about Biaxin effects that might show up years later in heart patients, rare but dangerous immune reactions associated with epilepsy drug Lamictal, and a warning not to use local anesthetic benzocaine for teething pain in infants.
With so many FDA reports, medical research, clinical trials, as well as buzz on social media and patient forums, one might think it should be easy to quickly recognize and act on emerging safety risks of drugs. But is response time to the alarming reports fast enough? A 2017
JAMA study found that "nearly a third of all drugs cleared by the FDA pose a safety risk." Researchers found that of the 222 drugs approved between 2001 and 2010, three drugs were pulled off the market and 61 drugs received black box warnings on their labels. On average, it took the FDA about four years to take safety-related responsive actions once the drugs were introduced.
Sources and more reading:
- Public dashboard of FAERS database
- Medwatch adverse report online form for consumers (Form 3500B)
- PDF version of Form 3500B for consumers. This PDF version is useful to review before you fill it out online because the online form is broken into separate pages that require you to fill out a section before advancing to the next page.
- New safety labeling changes, including black box
warnings, are found in the FDA's
Drug Safety Labeling Database. (We also provide links to
drug safety labeling changes for specific drugs on the Ask a
Patient website.)
- In August 2024, Ask a Patient website
began adding 2023 and 2024 top adverse event items for drugs in
our database. To access these one-page summary reports, search
for a drug, then click on the "case reports" link from either
search results or the drug's "viewrating" page.
-
"Understanding CDER’s Postmarket Safety Surveillance Programs
and Public Data
Older resources:
- FDA Adverse Event Surveillance Systems and MedWatch: 50 state meeting, 21 March, 2014. Presentation
(old link:
http://website.aub.edu.lb/sharp/Publications/safetyreporting.pdf
is no longer available online; this was the source of the FAERS
flowchart above.)
- "Postmarket drug safety: the view from the FDA." Q & A with FDA's Gerald J Dal Pan. Medscape article
(May 2017)
- About 20 percent of our poll respondents in 2013 said they had submitted an FDA adverse event report. AskaPatient poll from 2013
- Downing NS, Shah ND, Aminawung JA, et al. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA. 2017;317(18):1854–1863
Note: This article was originally posted in July 2018, but was
updated in August 2024 with the most recent information from the
FAERS database and FDA website.