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

QuarterWatch™ Reports
An independent perspective on emerging drug risks
QuarterWatch™ is published four times a year as a public service to provide an independent perspective on emerging drug risks. This scientific publication uses as its primary source recently released reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
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QuarterWatch™ Reports
June 2016
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
QuarterWatch™ Reports
April 2016
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
QuarterWatch™ Reports
January 2016
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
QuarterWatch™ Reports
September 2015
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
QuarterWatch™ Reports
May 2015
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
QuarterWatch™ Reports
January 2015
It seems clear that the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) is in need of modernization
QuarterWatch™ Reports
September 2014
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
May 2014
Allergic reactions second most frequently reported serious event • Hypersensitivity signals for omalizumab (XOLAIR) and telaprevir (INCIVEK) • Update on anticoagulants, rivaroxaban (XARELTO) and dabigatran (PRADAXA)