- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
FDA changes label for Trilipix
FDA has changed the label for fenofibric acid (Trilipix, Abbott). It now carries a warning that the agent may not lower the risk of myocardial infarction or stroke.
The label for fenofibric acid (Trilipix, Abbott) now carries a warning that the agent may not lower the risk of myocardial infarction or stroke. FDA added the new information after reviewing the results of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial.
In the ACCORD trial, there was no statistically significant difference in the risk of experiencing a major cardiac event between the group treated with fenofibrate plus simvastatin (Zocor, Merck) compared to simvastatin alone, said FDA pharmacist Kim Wu, PharmD, during a podcast in early November. FDA reviewed the trial as part of its ongoing investigation into the safety and efficacy of Trilipix.
Information from ACCORD was added to the Important Limitations of Use and the Warnings and Precautions sections of the package insert and the patient Medication Guide. Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce morbidity or mortality from coronary heart disease (CHD) in patients with type 2 diabetes. Similar results were seen in the Fenofibrate Intervention and Event Lower in Diabetes (or FIELD) trial.
Trilipix was approved in 2008 for use with a statin to reduce triglycerides and boost HDL cholesterol in patients with diabetes who also had mixed dyslipidemia and CHD or who were at risk for CHD and were already on optimal statin therapy to meet their LDL cholesterol goal.
FDA also directed the manufacturer to conduct a clinical trial to evaluate the cardiovascular outcomes of Trilipix in patients at high risk for cardiovascular disease who are already taking statins. Prior trials have been based on surrogate end points.
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.
