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Postmarketing surveillance

About: Postmarketing surveillance is a research topic. Over the lifetime, 1415 publications have been published within this topic receiving 36806 citations. The topic is also known as: Product Surveillance, Postmarketing.


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Journal ArticleDOI
01 May 2002-JAMA
TL;DR: To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market, Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999 is examined.
Abstract: ContextRecently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs.ObjectiveTo determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market.Design and SettingExamination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning).Main Outcome MeasuresFrequency of and time to a new black box warning or drug withdrawal.ResultsA total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years.ConclusionsSerious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.

932 citations

Journal ArticleDOI
24 Dec 2008-JAMA
TL;DR: In this sample of community-dwelling older adults, prescription and nonprescription medications were commonly used together, with nearly 1 in 25 individuals potentially at risk for a major drug-drug interaction.
Abstract: Rates of per-capita prescription medication use have increased considerably over the last several decades,1 as have the rates of use of over-the-counter medications2 and dietary supplements.3 Older adults are the largest per capita consumers of prescription medications1 and the most at risk for medication-related adverse events.4 Implementation of the Medicare Part D Prescription Drug Benefit and efforts by Congress and the US Food and Drug Administration to enhance postmarketing surveillance to better safeguard public health5,6 have also focused attention on use of prescription medications among older adults. Despite concerns about drug safety and new federal policies to improve older adults’ access to medications, current information on their concurrent use of prescription medications, over-the-counter medications, and dietary supplements is limited. Most epidemiologic studies examining medication use among older adults are nearly a decade old and aggregate persons 65 years and older.7,8 More than 200 new drugs have come to market in the United States since most of these studies were conducted.9 In addition, many studies use pharmacy claims or aggregate sales data to approximate use of prescription medications, thus measuring prescription acquisition rather than use.10 These data overestimate prescription medication use due to non-adherence,11,12 are limited to patients who purchase at least 1 prescription medication, and almost always exclude nonprescription therapies. This is important because medication use among older adults commonly involves multiple medications and the concurrent use of prescription medications with nonprescription therapies.13,14 The Slone survey,8,15 an annual telephone-based survey of the US population 18 years and older, does provide information regarding the use of prescription and nonprescription medications. However, the most recent Slone survey, conducted in 2006, reports little change in overall medication use since 1998 but does report that the rate of polypharmacy (ie, the use of ≥5 medicines) has increased.15 In the current study, we build on prior reports with a particular focus on older adults. In addition, we consider the potential impact of medication use on clinical outcomes that may result from drug-drug interactions, including interactions between prescription and nonprescription therapies. To do so, we used data from the National Social life, Health and Aging Project (NSHAP), a recent population-based survey of community-dwelling older adults in the United States.

926 citations

Journal ArticleDOI
TL;DR: Better than tarot cards or crystal balls, the authors show that intricate analyses of observational clinical data can improve physicians’ ability to predict the future—at least with respect to as yet uncharacterized adverse drug effects and interactions.
Abstract: Adverse drug events remain a leading cause of morbidity and mortality around the world. Many adverse events are not detected during clinical trials before a drug receives approval for use in the clinic. Fortunately, as part of postmarketing surveillance, regulatory agencies and other institutions maintain large collections of adverse event reports, and these databases present an opportunity to study drug effects from patient population data. However, confounding factors such as concomitant medications, patient demographics, patient medical histories, and reasons for prescribing a drug often are uncharacterized in spontaneous reporting systems, and these omissions can limit the use of quantitative signal detection methods used in the analysis of such data. Here, we present an adaptive data-driven approach for correcting these factors in cases for which the covariates are unknown or unmeasured and combine this approach with existing methods to improve analyses of drug effects using three test data sets. We also present a comprehensive database of drug effects (Offsides) and a database of drug-drug interaction side effects (Twosides). To demonstrate the biological use of these new resources, we used them to identify drug targets, predict drug indications, and discover drug class interactions. We then corroborated 47 ( P

640 citations

Journal ArticleDOI
TL;DR: This work analyzed all reports of suspected adverse drug reactions submitted to the Food and Drug Administration from the inception of the Adverse Event Reporting System database in 1969 through December 2002 to encourage physicians, pharmacists, other health care professionals, and patients to continue to report serious suspected and known adversedrug reactions to manufacturers and the food and drug Administration.
Abstract: Background The Adverse Event Reporting System is the primary surveillance database used by the Food and Drug Administration for identifying postmarketing drug safety problems. Methods We analyzed all reports of suspected adverse drug reactions submitted to the Food and Drug Administration from the inception of the Adverse Event Reporting System database in 1969 through December 2002. We documented drug withdrawals and restricted distribution programs based on safety concerns. Results During the 33-year period from 1969 when adverse drug event reporting was initiated through 2002, about 2.3 million case reports of adverse events for the cumulative number of approximately 6000 marketed drugs were entered in the database. Most reports were for female patients. During this period, numerous drug reactions have been identified and added to the product labeling as boxed warnings, warnings, precautions, contraindications, and adverse reactions. More than 75 drugs/drug products have been removed from the market due to safety problems. In addition, 11 drugs have special requirements for prescriptions or have restricted distribution programs. Drugs withdrawn or restricted represent a small proportion (about 1%) of marketed drugs. Conclusions The Food and Drug Administration’s Adverse Event Reporting System is the primary surveillance database used for the identification of safety problems of marketed drugs. Despite the limitations of underreporting, differential reporting, and uneven quality, submitted reports often allow the identification of serious adverse events that are added to the product labeling information. In rare instances, additional regulations, up to and including market removal, have been required. We encourage physicians, pharmacists, other health care professionals, and patients to continue to report serious suspected and known adverse drug reactions to manufacturers and the Food and Drug Administration.

468 citations

Journal ArticleDOI
TL;DR: Safety data from randomised controlled trials, open label extensions, and two phase IIIb open label trials demonstrate that long term adalimumab treatment is generally safe and well tolerated in patients with RA.
Abstract: Objective: To assess the safety of adalimumab in global clinical trials and postmarketing surveillance among patients with rheumatoid arthritis (RA). Methods: Safety data for adalimumab treated patients from randomised controlled trials, open label extensions, and two phase IIIb open label trials were analysed. In addition, postmarketing spontaneous reports of adverse events in the United States were collected following Food and Drug Administration approval of adalimumab on 31 December 2002. Results: As of 15 April 2005, the RA clinical trial safety database analysed covered 10 050 patients, representing 12 506 patient-years (PYs) of adalimumab exposure. The rate of serious infections, 5.1/100 PYs, was comparable to that reported on 31 August 2002 (4.9/100 PYs), and to published reports of RA populations naive to anti-tumour necrosis factor (TNF) therapy. Following implementation of tuberculosis (TB) screening in clinical trials, the rate of TB decreased. There were 34 cases of TB as of this analysis (0.27/100 PYs). The standardised incidence ratio for lymphoma was 3.19 (95% CI 1.78 to 5.26), consistent with the observed increased incidence in the general RA population. As of 30 June 2005, there were an estimated 78 522 PYs of exposure to adalimumab in the US postmarketing period. Seventeen TB cases were spontaneously reported (0.02/100 PYs) from the US. Rates of other postmarketing events of interest, such as congestive heart failure, systemic lupus erythematosus, opportunistic infections, blood dyscrasias, lymphomas, and demyelinating disease, support observations from clinical trials. Conclusion: Analyses of these data demonstrate that long term adalimumab treatment is generally safe and well tolerated in patients with RA.

384 citations


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Performance
Metrics
No. of papers in the topic in previous years
YearPapers
202340
202262
202136
202042
201940
201845