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FDA mandates enhanced safety check on TNF blockers
FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance, the agency said on November 3 in an ongoing safety review of this class of biologic products.
FDA is requiring that manufacturers of tumor necrosis factor (TNF) blockers perform enhanced safety surveillance in children, teenagers, and young adults, the agency said on November 3 in an ongoing safety review of this class of biologic products.
Manufacturers are expected to conduct thorough follow-up of reports of malignancy cases involving TNF blockers and submit all reports of malignancy to FDA as expedited reports (within 15 days) for pediatric and young adult patients (aged 30 years or younger). Manufacturers also will provide annual summaries and assessments of malignancies and TNF blocker utilization data to FDA.
This type of safety surveillance is important for the improved understanding of malignancies in pediatric and young adult patients treated with TNF blockers. It will allow FDA to capture and analyze all reported malignancies based on more complete, consistent reports, the agency said.
Healthcare workers should remain vigilant for cases of malignancy in patients treated with TNF blockers and report them to the FDA MedWatch program or manufacturer.
FDA will re-evaluate the enhanced surveillance requirement periodically during the next 10 years.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
