NEW YORK (Reuters Health)—Adverse drug events (ADEs) are more common when drugs are used off label, especially when the off-label use lacks strong scientific evidence, researchers from Canada report. “Our study demonstrated that physicians need to be cautious in prescribing off-label when there is a lack of strong scientific evidence for the use of the…
Tofacitinib on Hold for Psoriasis, Plus Anti-TNFs Top FDA List for Adverse Events
The FDA is asking for more safety analysis before approving tofacitinib to treat psoriasis. Also, adalimumab and etanercept received the greatest number of adverse and serious adverse events reported to the FDA in 2014…
FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning
The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and…
FDA Issues Warning for Joint Pain from Diabetes Drugs
Severe and disabling joint pain has been connected to the use of dipeptidyl peptidase-4 inhibitors and combination therapies for diabetes, prompting a new FDA warning…
Adverse Event Risk Data Drive Evaluation of Psoriasis Treatments
PSOLAR, the Psoriasis Longitudinal Assessment and Registry, is a multicenter, longitudinal, intercontinental, disease-based registry used to identify adverse events from commonly used psoriasis drugs.1 An evaluation of the risk of serious infection from systemic psoriasis treatments was recently published using data from PSOLAR. Ninety-three institutional review boards or ethics committees reported into the registry from…