Medication Monitor

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  • August 3, 2018

    FDA is warning that the antibiotic azithromycin should not be given long term to prevent an inflammatory lung condition known as bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. 

    Bronchiolitis obliterans syndrome is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Patients with cancer who undergo stem cell transplants from donors are at risk for bronchiolitis obliterans syndrome.There are no known effective antibiotic treatments that prevent the syndrome, and azithromycin is not approved for this use. It is an FDA-approved antibiotic used to treat many types of infections affecting the lungs, sinuses, skin, and other parts of the body.

    The drug, which has been used for more than 26 years, is sold under the brand names Zithromax and Zmax and as generics by many different drug companies. Pfizer, the manufacturer of brand name azithromycin, is providing a Dear Healthcare Provider letter on this safety issue to health professionals who care for patients undergoing donor stem cell transplants.

    FDA is reviewing additional data and will communicate its conclusions and recommendations when the review is complete. Patients who have had a stem cell transplant should not stop taking azithromycin without first consulting with their health care provider.

  • August 1, 2018

    FDA approved lusutrombopag, a once-daily, orally administered, small molecule thrombopoietin receptor agonist, for treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

    Approval was based on two randomized, double-blind, placebo-controlled trials involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count of less than 50 x 109/L. Patients were randomized 1:1 to receive 3 mg of lusutrombopag or placebo once daily for up to 7 days.

    In one trial, 78% of patients (38/49) receiving lusutrombopag required no platelet transfusion prior to the primary invasive procedure, compared with 13% (6/48) who received placebo. In the second trial, 65% (70/108) of patients who received lusutrombopag required no platelet transfusion prior to the primary invasive procedure or rescue therapy for bleeding from randomization through 7 days after the procedure, compared with 29% (31/107) receiving placebo.

    The most common adverse reaction (≥3% of patients) was headache.

    The recommended lusutrombopag dosage is 3 mg orally once daily with or without food for 7 days.

  • July 31, 2018

    FDA is moving cesium chloride (CsCl) to the category of bulk drug substances (active pharmaceutical ingredients) that present significant safety risks in compounding. CsCl is a mineral salt that is sometimes taken either orally or by injection by cancer patients who seek alternative treatments; however, no CsCl products have been approved by FDA to treat cancer or other diseases. Use of cesium poses significant safety risks (e.g., heart toxicity) and is potentially associated with death. These events can occur with oral administration and/or injection. 

    FDA intends to take action, such as issuing a warning letter or pursuing a seizure of product or injunction, if it encounters compounding using substances placed in this category. 

    FDA reviewed all adverse events related to CsCl and other cesium salts that were reported to FDA or that were published in medical journals through June 30, 2018. FDA identified 23 reports describing serious adverse events associated with cesium, including heart problems.

    Five reports submitted to FDA and 18 published in the medical literature described patients who experienced adverse events from cesium. Seventeen of those reports were associated with CsCl, compared to 6 with other cesium salts like cesium carbonate. Most patients took cesium to try to treat cancer. The doses described in these cases ranged from 500 mg taken every day to 100 g taken over 11 days. Most reports did not identify where the cesium was obtained. In at least eight of these cases, health professionals measured cesium concentrations in the bodies of cesium users and found measured quantities that were several hundred to thousand-fold higher than normal.

    Reported adverse events included QT prolongation, low potassium, seizures, potentially lethal arrhythmias, fainting, cardiac arrest, and death. QT prolongation was the most frequently reported adverse event. QT prolongation in the presence of low potassium usually improves quickly when potassium is administered, but 9 out of 11 of these patients receiving the potassium treatment either did not respond as well as expected or did not respond at all. Of the remaining two patients, one improved as expected, and one had an unknown response. Three patients were treated with a cesium-binding agent called Prussian Blue and had an improvement in the QT within a few days.

    For others, it took several weeks after the cesium was stopped for their QT prolongation to improve. This is probably because when cesium is taken on an ongoing basis, it leaves the body very gradually and may take from 6 months to 2 years to be eliminated.

    Six deaths were reported with use of cesium. FDA considers two of these deaths to be possibly associated with cesium chloride. The reports for these two deaths described cardiac arrest or arrhythmia occurring during, or within 24 hours of injection, of cesium. Three reports did not describe the cause of death, and one person may have died from advanced cancer and bloodstream infection.

  • July 31, 2018

    FDA is alerting health professionals and patients, as well as veterinarians and animal owners, of Ranier’s Rx Laboratory’s voluntary recall of unexpired compounded drug products intended to be sterile. The recalled products were dispensed between January 17, 2018, and July 10, 2018. See Ranier’s notification for additional information.

    Health professionals and veterinarians should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Administration of a nonsterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

    FDA issued a warning letter to Ranier’s Compounding in March 2017 following an inspection. During FDA’s recent follow-up inspection of Ranier’s compounding facility, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about the company’s ability to ensure the sterility of its drug products.

    On June 6, 2018, FDA recommended that Ranier’s Compounding recall all unexpired human and animal drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility. On June 7, 2018, Ranier’s Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment.

    To date, FDA is not aware of any adverse events associated with the use of products from Ranier’s Compounding. Patients who have received drug products produced by Ranier’s Compounding and have concerns should contact their health care provider.

  • July 31, 2018

    Indivior PLC announced FDA approval of the first once-monthly, long-acting injectable (LAI) containing risperidone to treat schizophrenia in adults. Clinically relevant levels were reached after the first injection without use of a loading dose or any supplemental oral risperidone.

    The extended-release delivery system forms an S.C. depot that provides sustained levels of risperidone over 1 month. Initial peak risperidone plasma levels occur within 4 to 6 hours of dosing and are due to an initial release of the drug during the depot formation process.  

    Efficacy of the new formulation was evaluated in a pivotal Phase III randomized, double-blind, placebo-controlled, 8-week study of 354 patients. The study demonstrated an improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale (PANSS) total score at day 57. The improvement in Clinical Global Impression Severity of Illness (CGI-S) was also statistically significant at day 57. Clinical trials were designed for the product to be initiated with neither a loading dose nor any supplemental risperidone.

    Safety was evaluated in 814 adults with schizophrenia who received at least one dose during clinical trials. A total of 322 patients were treated with the injectable agent for at least 6 months, with 234 of those treated for at least 12 months. The systemic safety profile was consistent with the known safety profile of oral risperidone.

    The most common systemic adverse reactions were increased weight, sedation/somnolence, and musculoskeletal pain. The most common injection-site reactions were injection-site pain and reddening of the skin.

    The labeling comes with a boxed warning cautioning that older adult patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. The agent is not approved for use in patients with dementia-related psychosis.