2 That same year, there were 320,000 serious adverse events and nearly 50,000 deaths. In 2008, the FDA received more than 530,000 reports of suspected ADEs, of which some 33,000 were submitted directly to the FDA most were submitted by manufacturers. It is challenging to estimate the true incidence of ADEs in the general population, with uncertainty about the number of patients exposed to a given drug, poor documentation, and underreporting, as well as the effect of publicity around a particular drug on the reported frequency of an event.

In the regulatory setting, adverse events are categorized as adverse drug events (ADEs) and, as a subset of ADEs, adverse drug reactions (ADRs) ( TABLE 1). Pharmacovigilance involves the continued monitoring of the safety profiles of products throughout their life cycles, and particularly once in the marketplace, through scientific data-gathering activities relating to the detection, assessment, and understanding of adverse events.ДЄdverse events are undesirable experiences associated with the use of a medical product. For example, study participants may not necessarily represent вЂњreal worldвЂќ patients receiving the drug once it is on the market.

While clinical trials help to establish the efficacy of a drug and to reveal common adverse events, there are limitations in identifying safety concerns in this setting. A decision by the FDA to approve a drug for market is based on a thorough review of that drugвЂ™s safety and efficacy to determine whether the benefits outweigh the risks associated with its use.

Adverse reaction vs side effect