Date Published: 29 September 2017

FAERS improves access to concerns about adverse drug reactions

When people take prescribed pharmaceutical drugs or medicate their children or other dependants with pharmaceutical products it is generally with faith in the expertise of physicians and other healthcare professionals, and with expectation of improvment, or at least the safe management of a medical situation. Nevertheless it is well-known that pharmaceutical products can have a wide range of undesireable side-effects or unsuitability for certain people or in certain situations. Ideally decisions about use of medications are taken in consideration of such information as well as the patients needs, requirements and detailed medical history. Despite the best intentions of both the prescribers and developers of pharmaceutical products, some issues only become known when the product is already in general use by patients who are not participating in clinical trials but are merely requesting the most appropriate medical care for their particular situation.

When use of a prescribed drug or other medical product appears to cause or at least be associated with any form of adverse change in the patient, that person or his or her carers are likely to feel concerned and might want to share that information with the prescribing professional and perhaps also those responsible for regulation the drug or product. Anyone affected by a possible adverse effect of a drug might also want to find out if others have reported similar experiences. The process for doing so has been improved, at least for people in the United States. This is thanks to the U.S. Food and Drug Administration (FDA) which has [28 Sept '17] launched a new user-friendly search tool to improve access to data about adverse events associated with drug and biologic products. Such data can now be accessed via the FDA's Adverse Event Reporting System (FAERS).

" 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."

According to a recent statement by the FDA, the new dashboard enables users to search for and access data by criteria such as:

  • pharmaceutical drug / biological product,
  • age of the patient,
  • type of adverse event,
  • year the adverse event occurred, or
  • within a specific timeframe.

As well as simplifying the process by which members of the public can search for and find information about any adverse events reported as possibly associated with specific drug or biologic products, the FDA hopes that the increased transparency will also boost submission of more detailed and complete reports from patients, health care professionals and others.

In its recent statement the FDA explained that it uses FAERS for surveillance, such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance with reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in the FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to monitor the safety of products after they are marketed. If a potential safety concern is identified in FAERS, further evaluation is undertaken.

" Our focus on safety extends beyond approval," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.
" In fact, our staff spends a lot of time looking at FAERS reports received regarding approved drug and biologic products and these reports can be very valuable components of our safety assessments. By giving people a better understanding of these data, and the associated limitations, we hope the new interface will encourage people to submit more complete reports."

The FAERS dashboard provides many more ways of searching for and finding information about adverse events reported to the FDA for many drug and biologic products than have been available in the past. Users should, however, be aware of remaining limitations concerning this resource. For example, while FAERS contains reports about adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. The FAERS data alone does not indicate the safety profile of the drug or other pharmaceutical product. The FDA stated that patients should still talk to their health care professional if they have any concerns regarding their medications.

In addition to the FAERS database for drugs and biologics, the FDA has adverse event reporting programs and databases for foods, dietary supplements, and cosmetics (CFSAN Adverse Event Reporting System, or "CAERS"), medical devices (Manufacturer and User Facility Device Experience, or "MAUDE") and vaccines (Vaccine Adverse Event Reporting System, or "VAERS" that the FDA co-manages with the Centers for Disease Control and Prevention). It encourages patients and health care professionals to report adverse events or quality problems experienced with the use of drug and medical products to the FDA's MedWatch Adverse Event Reporting program. This can be done by completing and submitting the report online at

Source (or main source)U.S. Food and Drug Administration (FDA), USA, info retrieved 29 Sept 2017

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