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FDA reports increased risk of death in patients with permanent AF taking dronedarone, revises drug label
In mid-December, FDA reported that dronedarone (Multaq) increased the risk of serious cardiovascular events, including death, when used in patients with permanent atrial fibrillation (AF), according to its safety drug communication.
In mid-December, FDA reported that dronedarone (Multaq) increased the risk of serious cardiovascular events, including death, when used in patients with permanent atrial fibrillation (AF), according to its safety drug communication.
The review was based on data from 2 clinical trials, the PALLAS trial (Permanent Atrial FibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy) and the ATHENA trial, which supported the drug's approval for treatment of nonpermanent AF.
The drug label for dronedarone has been revised with a number of changes and recommendations.
ECG RECOMMENDED EVERY 3 MONTHS
In addition, healthcare providers should monitor cardiac rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, dronedarone must be stopped or, if clinically indicated, the patient should be cardioverted.
In addition, patients who are prescribed dronedarone should receive appropriate antithrombotic therapy.
Dronedarone was FDA approved in July 2009 and is indicated to reduce hospitalizations for AF in patients in sinus rhythm with a history of nonpermanent AF (known as paroxysmal or persistent AF).
FDA is also reviewing the Risk Evaluation and Mitigation Strategy for dronedarone to determine the changes needed to ensure that the benefits of the drug outweigh the cardiovascular risks.
FDA believes that dronedarone provides a benefit for patients with nonpermanent AF and recommends that healthcare professionals who prescribe the drug follow the recommendations in the revised dronedarone drug label.
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.
