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FDA modifies REMS for 2 platelet-booster drugs
In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).
In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).
"An FDA-initiated review of the current information has determined that while safety risks for both Nplate and Promacta still exist, certain restrictive requirements of the REMS programs are no longer necessary to ensure that the benefits of the drugs outweigh their risks," FDA said.
Nplate and Promacta were both approved in 2008 for the treatment of chronic immune thrombocytopenia (ITP) in adults who have not responded to corticosteroids, immunoglobulins, or to the removal of their spleen (splenectomy).
ESTABLISH LONG-TERM SAFETY THROUGH ONGOING TRIALS
However, because the underlying medical conditions in patients with chronic ITP made the safety data collected by the REMS programs difficult to interpret, FDA has determined that the safety data collection requirements are not informative and are no longer necessary for that purpose.
Rather, FDA concluded that long-term safety is best established through ongoing clinical trials, post-approval studies, and post-marketing adverse event reports.
Changes to the REMS state that healthcare professionals, hospitals, specialty-care facilities, and patients are no longer required to be enrolled in the Nplate NEXUS Program or the Promacta CARES Program to prescribe, dispense, or receive these products.
Healthcare professionals also will no longer be required to complete periodic safety forms for patients receiving these drugs.
Pharmacies and pharmacists no longer are required to enroll in the Promacta CARES Program or verify prescriber and patient enrollment before dispensing Promacta.
The modified REMS programs will include a communication plan that will inform healthcare professionals about the changes to the REMS and the safety risks associated with each product, according to FDA.
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.
