FDA actions in brief
A discussion of new FDA-approved indications and formulations of drugs
Key Points
New storage instructions were approved for exenatide (Byetta, Amylin/Eli Lilly). The agent can now be stored at room temperature after first use.
Lisdexamfetamine (Vyvanse, Shire/New River) was approved for the treatment of attention-deficit/hyperactivity disorder (ADHD).
Atorvastatin (Lipitor, Pfizer) was approved for reducing the risk of nonfatal heart attacks, fatal and nonfatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients with heart disease. This agent was previously approved to reduce the risk of cardiovascular events in patients without heart disease.
A patch containing diclofenac (Flector Tissuegel, Institut Biochimique SA) was approved for the treatment of acute pain due to minor strains, sprains, and contusions.
Cyclobenzaprine (Amrix, ECR) was approved in a new extendedrelease capsule formulation as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Duloxetine (Cymbalta, Eli Lilly) was approved for the treatment of generalized anxiety disorder. Duloxetine was approved previously for the treatment of major depressive disorder and diabetic peripheral neuropathic pain.
A new tablet formulation of ramipril (Altace, King) was approved for the treatment of hypertension; reduction in risk of myocardial infarction, stroke, and death from cardiovascular causes; and treatment of stable patients who have demonstrated signs of congestive heart failure within the first few days after sustaining acute myocardial infarction.
A new 200-mg strength of extended-release morphine (Kadian, Alpharma) was approved for the management of moderate-tosevere chronic pain. This agent was previously approved in strengths of 20, 30, 50, 60, 80, and 100 mg.
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.
