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FDA requires several changes to bevacizumab label to include safety information
Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.
Key Points
Safety information changes to the package insert for bevacizumab (Avastin, Genentech) were issued by FDA on September 30, 2011. These changes included safety information regarding the risk of ovarian failure, venous thromboembolism (VTE), and bleeding in patients treated with anticoagulants after first VTE episode, and osteonecrosis of the jaw. Bevacizumab is currently indicated for the treatment of metastatic breast, renal cell, or colorectal cancer; non-squamous, non-small cell lung cancer; and glioblastoma.
New to the "Warnings and Precautions" section is a statement that urges women to be informed of the risk of ovarian failure with bevacizumab treatment. This stems from a sub-study of 179 women treated with mFOLFOX chemotherapy regimen plus bevacizumab versus mFOLFOX regimen alone for the treatment of stage 1 or 3 colorectal cancer (off-label use). The relative risk of ovarian failure in women receiving bevacizumab was 14% (95% CI, 4%– 53%) compared to women who did not receive bevacizumab. Ovarian function recovered in 23% of females who experienced failure.
In patients who were treated with bevacizumab for metastatic colorectal cancer, the incidence of first VTE was higher (13.5%) compared to patients without bevacizumab (9.6%). The incidence of a subsequent VTE in those patients who were treated with an anticoagulant was also increased in the bevacizumab group (31.5%) compared to those without bevacizumab treatment (25.6%), as was the incidence of bleeding (27.4% vs 20.9%). This data has been added to the "Clinical Trial Experience" section of the bevacizumab label.
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.
