Medication Monitor



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  • October 25, 2018

    Sprayology is voluntarily recalling all lots within expiry from 10/18 to 7/22 of its aqueous-based homeopathic product line because of possible microbial contamination.

    Administration or use of drug products with microbial contamination could result in increased infections that may require medical intervention or be life threatening to certain individuals.

    The products are for assorted symptom relief and can be identified by the main label on the bottle and by the expiration date printed on the backside of the label. Each recalled product is an individual 1.38-oz. oral spray in white bottle manufactured at the King Bio facility in Asheville, NC. The product was distributed nationwide via wholesale, retail, and online sales.

    View the list of recalled products here. 

  • October 25, 2018

    Endo Pharmaceuticals is voluntarily recalling two lots of methocarbamol (Robaxin) 750-mg tablets in 100-count bottle pack. The product labels contain incorrect daily dosing information, misstating the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily."

    Patients who follow the label directions may experience significant drowsiness or dizziness that would put them at risk of falls or an overdose that could result in seizures, coma, or death. 

    The product is indicated as an adjunct therapy to rest, physical therapy, and other measures to relieve the discomfort associated with acute, painful musculoskeletal conditions. 

    The recall includes the product lot 216702P1, expiration date September 2020; and lot 220409P1, expiration date January 2021.

    To date, Endo Pharmaceuticals has not received any reports of adverse events related to this recall.

  • October 25, 2018

    FDA has approved a new indication for rivaroxaban to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in patients with chronic coronary or peripheral artery disease (CAD/PAD). It is now the first and only factor Xa inhibitor approved for patients with these conditions.

    Approval was based on results from the COMPASS trial, which showed a significant 24% reduction in the risk of major CV events in patients with chronic CAD and/or PAD with the rivaroxaban 2.5-mg vascular dose twice daily plus aspirin 100 mg once daily, compared with aspirin alone.

    This finding was driven by a 42% reduction in stroke, 22% reduction in CV death, and 14% reduction in heart attack. The risk of major bleeding was significantly higher in patients taking the rivaroxaban/aspirin regimen compared with aspirin alone, with no significant increase in fatal or intracranial bleeds.

  • October 25, 2018

    Dupilumab gained FDA approval as add-on maintenance therapy for patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

    Dupilumab inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the type 2 inflammation that may underlie moderate to severe asthma. This effect is associated with the reduction of inflammatory biomarkers, including fractional exhaled nitric oxide, immunoglobulin E, and eotaxin-3.

    For people with asthma, dupilumab comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose.

    Approval for the indication was based on a pivotal trial program that evaluated 2,888 adult and adolescent patients with moderate to severe asthma in three randomized, placebo-controlled, multicenter trials for 6 months to 1 year (24 to 52 weeks).

    The agent comes in a pre-filled syringe and is intended for subcutaneous injection under the guidance of a health care provider. It can be given in a clinic or, for convenience, at home by self-administration after training by a health professional.

    Dupilumab was previously approved for treatment of adults with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

  • October 25, 2018

    Genentech announced an update to the rituximab label to include information on follow-up treatment of adult patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) who have achieved disease control with induction treatment.

    GPA and MPA are two types of antineutrophil cytoplasmic antibody–associated vasculitis, or inflammation of the blood vessels, that largely affects the small blood vessels of the kidneys, lungs, and a variety of other organs.

    The label update was based on data from a Roche-supported study by the French Vasculitis Study Group showing that treatment with the rituximab regimen (rituximab and glucocorticoids) resulted in fewer major relapses by month 28 compared with treatment with azathioprine. The observed safety profile was consistent with that previously observed in this patient population. 

    In combination with glucocorticoids, rituximab was approved by FDA in 2011 for adult patients with GPA and MPA with the precaution that limited data were available on the safety and efficacy of subsequent courses of rituximab in patients with GPA and MPA, and that the safety and efficacy of retreatment with rituximab had not been established. As part of this label update, the precaution has been removed from the rituximab prescribing information.

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