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FDA Actions in Brief June 2011 (Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev)
Recent FDA Approvals (through May 2011) related to Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev
Telaprevir (Incivek, Vertex) tablets were approved for a broad group of people with genotype 1 chronic hepatitis C (CHC) with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis.
Boceprevir (Victrelis, Merck) was approved for the treatment of genotype 1 CHC infection, in combination with peginterferon alfa and ribavirin, in adult patients (aged 18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Rilpivirine (Edurant, Tibotec Therapeutics, a division of Centocor Ortho Biotech) in combination with other antiretroviral drugs was approved for the treatment of HIV-1 infection in adults who have never taken HIV therapy.
Argatroban injection (in sodium chloride) (Sandoz), the first ready-to-use alternative to concentrate formulation, was approved as an anticoagulant for the prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.
Everolimus (Afinitor, Novartis) was approved for the treatment of patients with progressive neuroendocrine tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body.
Linagliptin (Tradjenta, Boehringer Ingelheim) tablets were approved, used with diet and exercise, to improve blood glucose control in adults with type 2 diabetes.
An expanded use of levoleucovorin (Fusilev, Spectrum Pharmaceuticals) was approved for patients with advanced metastatic colorectal cancer. This new indication of Fusilev where it will be used in combination with 5-fluorouracil, supplements the original 2008 FDA approval of the drug.
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.
