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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).

Browse Issues

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
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)