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. FDA releases, for research and data analysis, excerpts of all domestic and foreign reports it receives into the FDA Adverse Event Reporting System (FAERS). 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. QuarterWatch® is published four times a year as a public service to provide an independent perspective on emerging drug risks.

Browse Issues

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
Allergic reactions second most frequently reported serious event • Hypersensitivity signals for omalizumab (XOLAIR) and telaprevir (INCIVEK) • Update on anticoagulants, rivaroxaban (XARELTO) and dabigatran (PRADAXA)
Psychiatric side effects prominent in 10 of 15 most frequently reported drugs • Ibuprofen associated with severe hypersensitivity • Few reports for antibiotics and albuterol
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
Varying signals for pancreatitis, hypersensitivity, and cancer • Three oral versus two injectable agents compared • Link to human and animal studies of the pancreas
Finasteride (PROPECIA, PROSCAR) and possibly persistent sexual side effects • Methylphenidate patch (DAYTRANA) and product problems • Update on anticoagulants dabigatran (PRADAXA) and rivaroxaban (XARELTO)
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.
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
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.