QuarterWatch™ Reports

Statement for the FDA advisory committee meeting on September 14, 2016 • Evidence for suicidal behaviors and violence

SGLT2 Inhibitors - a health gamble with a new class of drugs for diabetes • Oral anticoagulants linked to nearly 3,000 reported patient deaths, 16,000 hemorrhages • Overall opioid use drops, but oxycodone use grows

Cancer risks of biological products for psoriasis • Tadalafil (CIALIS), sildenafil (VIAGRA) and sudden hearing loss• Non-serious reports increase FDA case total by 60% over previous year

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)