Medication Monitor



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Generic Name (Trade Name—Company)
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  • September 26, 2018

    FDA approved moxetumomab pasudotox-tdfk injection for I.V. use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. The agent is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.

    HCL is a rare, slow-growing cancer of the blood in which the bone marrow makes too many lymphocytes. HCL is named after these extra B cells, which look “hairy” when viewed under a microscope. As the number of leukemia cells increases, fewer healthy white blood cells, red blood cells, and platelets are produced.

    Efficacy of the agent was studied in a single-arm, open-label clinical trial of 80 patients who had received prior treatment for HCL with at least two systemic therapies, including a purine nucleoside analog. The trial measured durable complete response (CR), defined as maintenance of hematologic remission for more than 180 days after achievement of CR. Thirty percent of patients in the trial achieved durable CR, and the overall response rate (number of patients with partial or complete response to therapy) was 75%.

    Common adverse effects include infusion-related reactions, edema, nausea, fatigue, headache, fever, constipation, anemia, and diarrhea.

    The prescribing information includes a boxed warning to advise health professionals and patients about the risk of developing capillary leak syndrome, a condition in which fluid and proteins leak out of tiny blood vessels into surrounding tissues. Symptoms of capillary leak syndrome include difficulty breathing, weight gain, hypotension, or swelling of arms, legs, and/or face.

    The boxed warning also notes the risk of hemolytic uremic syndrome, a condition caused by the abnormal destruction of red blood cells. Patients should be made aware of the importance of maintaining adequate fluid intake, and blood chemistry values should be monitored frequently.

    Other serious warnings include decreased renal function, infusion-related reactions, and electrolyte abnormalities. Women who are breastfeeding should not take the drug.

  • September 12, 2018

    Pharm D Solutions is voluntarily recalling all sterile compounded drug products dispensed with the past 12 months because of concerns that practices at the pharmacy may pose a risk of contamination to products intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

    Administration of a nonsterile product that is intended to be sterile by S.C., I.M., I.V., or ocular routes of administration may result in serious injury or death.

    Pharm D Solutions stated that to date, it is not aware of any adverse events related to this recall nor any indication that the compounded sterile drug products being recalled are actually contaminated. No medications or any component thereof have been shown to be nonsterile.

    The recall encompasses all compounded sterile drug products, within expiry, that were dispensed within the last twelve months. The sterile drug products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The recall does not affect the pharmacy’s nonsterile compounded products or retail pharmacy operations.

  • September 12, 2018

    FDA has approved riluzole oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). It is the first and only easy-to-swallow thickened riluzole liquid for ALS and is administered twice daily via an oral syringe.

    Approval was based on bioavailability studies comparing oral riluzole tablets to riluzole oral suspension. While riluzole's mechanism of action is not fully understood, in clinical studies it has been shown repeatedly to modulate glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.

    The most common adverse effects of the oral suspension are consistent with the established clinical profile of riluzole and include oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.

    Riluzole oral suspensionhas has received orphan drug designation from FDA. The product will be available in mid-October.

  • September 12, 2018

    FDA has approved buprenorphine and naloxone sublingual film under the trade name Cassipa for maintenance treatment of opioid dependence. This action provides a new dosage strength (16 mg/4 mg) of the sublingual film, which is also approved in both brand name and generic versions and in various strengths.

    Cassipa should be used as part of a complete treatment plan that includes counseling and psychosocial support and should be used only after patient induction and stabilization up to a dose of 16 mg of buprenorphine using another marketed product.

    Common adverse events are oral numbness, burning mouth, inflammation of oral mucous membrane, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

    These products may only be prescribed by Drug Addiction Treatment Act–certified prescribers.

  • September 12, 2018

    FDA is alerting consumers and health professionals to a voluntary recall of all water- and alcohol-based Beaumont Bio Med Inc. (Grand Rapids, MI) drug products. These products, labeled as homeopathic, are being recalled due to microbial contamination at the manufacturing facility. 

    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.

    These products were manufactured at the King Bio, Inc., facility in Asheville, NC. Previously, FDA alerted consumers to HelloLife’s voluntary recall of drug products labeled as homeopathic, also manufactured by King Bio.

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