QuarterWatch™ Reports

Signals for new sleep medication suvorexant (BELSOMRA) • Opioids: Hydrocodone exposure declines while higher potency drugs increase • Update on new diabetes drugs blocking kidney glucose reabsorption

Two tumor necrosis factor blockers lead overall report totals in 2014 • Novel oral anticoagulant safety profiles diverge, but risks remain high • Atorvastatin (LIPITOR) accounts for most safety-related lawsuit reports

Zolpidem (AMBIEN) safety profile shows widespread unsafe use • Adverse event signals for canagliflozin (INVOKANA), a new diabetes medication • 20,632 incomplete rosiglitazone (AVANDIA) reports of heart attack and stroke

It seems clear that the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) is in need of modernization

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