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FDA: Doribax trial halted for increase in death rate, poor clinical cure rate
FDA recently announced that a clinical trial evaluating the effects of doripenem (Doribax, Janssen) on the treatment of patients with ventilator-associated pneumonia was halted because of an increase in death rate and a poor clinical cure rate.
FDA recently announced that a clinical trial evaluating the effects of doripenem (Doribax, Janssen) on the treatment of patients with ventilator-associated pneumonia was halted because of an increase in death rate and a poor clinical cure rate.
The prospective, randomized, double-blind, double-dummy, multicenter phase 3 study was designed to evaluate treatment with doripenem to imipenem-cilastatin. However, the interim analyses were demonstrating a numerically higher mortality rate and a numerically lower clinical cure rate among patients treated with a fixed 7-day course of doripenem (1 g, 4-hour infusion, q8h) compared with those treated with a fixed 10-day course of imipenem-cilastatin (1g, 1 hour infusion, q8h).
Interim results for 274 of the planned 524 patients showed that patients receiving doripenem had a 28-day, all-cause mortality rate of 21.5% compared with the 14.8% in patients receiving imipenem-cilastatin (Primaxin, Merck). In addition, patients in the treatment group had an 11.2% lower rate of being cured compared with patients in the control group.
Doripenem is approved for the treatment of complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis in adults.
“Doribax is still considered safe and effective for its approved indications,” FDA stated. However, healthcare professionals should know that doripenem is not approved to treat any type of pneumonia, and the recommended dose is 500 mg every 8 hours intravenously, given over 1 hour, for a total of 5 to 14 days (depending on indication) in adults.
Janssen said that it is committed to ensuring the drug is used safely and effectively and advises healthcare professionals to report any serious adverse events suspected to be associated with the use of doripenem to Janssen at (800) 526-7736. The company also recommends that serious adverse event information be reported directly to FDA’s MedWatch reporting system.
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.
