It seems clear that the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) is in need of modernization
QuarterWatch® Reports
An independent perspective on emerging drug risks
QuarterWatch® is the publication of an independent ISMP surveillance program that monitors adverse drug events reported to the US Food and Drug Administration (FDA) by manufacturers, health professionals, and the public. The goal of QuarterWatch® is to identify signals that may represent important drug safety issues, which often require further investigation to determine their frequency and establish a causal relationship to the suspect drug.
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QuarterWatch® Reports
Dimethyl fumarate (TECFIDERA): tolerability problems with a new multiple sclerosis drug • Varenicline (CHANTIX): reports of suicidal/homicidal thoughts surpass all other drugs • Sodium oxybate (XYREM): a restricted drug with severe side effects • Fingolimod (GILENYA): cardiac, vision, and pregnancy risks
QuarterWatch® Reports
Allergic reactions second most frequently reported serious event • Hypersensitivity signals for omalizumab (XOLAIR) and telaprevir (INCIVEK) • Update on anticoagulants, rivaroxaban (XARELTO) and dabigatran (PRADAXA)
QuarterWatch® Reports
Psychiatric side effects prominent in 10 of 15 most frequently reported drugs • Ibuprofen associated with severe hypersensitivity • Few reports for antibiotics and albuterol
QuarterWatch® Reports
Anticoagulants leading drug safety problem reported directly to FDA • Three anti-TNF agents dominate manufacturer reports of new, serious injuries • Fentanyl patches (DURAGESIC) prominent in product problems and medication errors • Lower limb fractures when taking alendronate (FOSAMAX) a major reported adverse event
QuarterWatch® Reports
Varying signals for pancreatitis, hypersensitivity, and cancer • Three oral versus two injectable agents compared • Link to human and animal studies of the pancreas
QuarterWatch® Reports
Finasteride (PROPECIA, PROSCAR) and possibly persistent sexual side effects • Methylphenidate patch (DAYTRANA) and product problems • Update on anticoagulants dabigatran (PRADAXA) and rivaroxaban (XARELTO)
QuarterWatch® Reports
The last four years have seen a 90% increase in the number of serious adverse drug event reports received by the Food and Drug Administration (FDA). We examine the reasons for the increase in detail in the full report.
QuarterWatch® Reports
The most frequently identified suspect drugs in direct reports to the FDA were the anticoagulants dabigatran (PRADAXA) and warfarin (COUMADIN), showing that inhibiting clotting ranks among the highest risk of all drug treatments.
QuarterWatch® Reports
Signals for severe side effects associated with fingolimod (GILENYA) and infliximab (REMICADE) • Updated findings for dabigatran (PRADAXA) and metoclopramide (REGLAN).
QuarterWatch® Reports
Strong signal for serious bleeding with the new anticoagulant drug dabigatran (PRADAXA) • Reports of brain damage associated with metoclopramide (REGLAN) • A review of quarterly data for the five most widely prescribed drugs in the US
QuarterWatch® Reports
Signals for dabigatran (PRADAXA) and dalfampridine (AMPYRA) • Updates on our reporting on the smoking cessation drug varenicline (CHANTIX) • Annual ranking of the drugs most frequently associated with reports of serious injury
QuarterWatch® Reports
Liraglutide (VICTOZA) Launch Spurs Pancreatitis Reports • Quetiapine (SEROQUEL) and Irreversible Injury • New Varenicline (CHANTIX) Suicide Cases
QuarterWatch® Reports
Varenicline (CHANTIX) Safety Problems Continue • Levofloxacin (LEVAQUIN) Cases Lead Antibiotics • Dronedarone (MULTAQ) Update • Johnson & Johnson OTC Recalls
QuarterWatch® Reports
In a review of MedWatch reports received by the Food and Drug Administration in the first quarter of 2010 we identified four signals of potential drug safety problems.
QuarterWatch® Reports
In 2009, the U.S. Food and Drug Administration received 19,551 reports of patient deaths associated with drug therapy, a 14% increase compared to the previous year and a 3-fold increase over the past decade.
QuarterWatch® Reports
Thousands of people are reporting they have lost their sense of smell after using Zicam Nasal Gel and Swab products that contained zinc.
QuarterWatch® Reports
Serious, disabling and fatal adverse events reported to the FDA increased by 25% for the full year of 2008, the largest increase since the beginning of our historical data in 1998.