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FDA warns of new malignancies with multiple myeloma treatment
FDA recently issued a warning about an increased risk of developing new cancers for patients taking lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma.
FDA recently issued a warning about an increased risk of developing new cancers for patients taking lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma.
FDA reviewed clinical trials published after lenalidomide was approved, which found that newly-diagnosed patients with multiple myeloma had a significantly increased risk of developing second primary malignancies compared to patients who received a placebo. The studies showed an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin's lymphoma.
"Take into account both the potential benefit of Revlimid and the risk of second primary malignancies when considering treatment....[and] encourage patients to read the Medication Guide when they receive their Revlimid prescription," FDA stated in its safety announcement.
FDA reviewed 3 prospective, randomized trials in which patients with newly-diagnosed multiple myeloma received initial chemotherapy or chemotherapy plus blood stem cell transplantation followed by treatment with lenalidomide or a placebo.
A pooled analysis of the 3 ongoing trials showed 65 primary malignancies among 824 patients in the lenalidomide treatment arms compared to 19 second primary malignancies among 665 patients in the treatment group that did not include lenalidomide maintenance. "This difference is almost a 3-fold increase in new malignances for the groups receiving Revlimid versus the groups that did not receive Revlimid," FDA stated.
FDA also conducted a retrospective pooled analysis of second primary malignances from 2 clinical trials that supported FDA's initial approval of lenalidomide for relapsed multiple myeloma. The multicenter, parallel-group trials examined lenalidomide plus high-dose dexamethasone therapy versus dexamethasone alone in the treatment of patients with relapsed or refractory multiple myeloma. The incidence rates of developing a second primary malignancy during the treatment phase of these trials were 3.98 per 100 person-years for patients in the lenalidomide/dexamethasone group and 1.38 per 100 person-years for those in the placebo-dexamethasone groups.
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.
