Medication Monitor



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  • July 31, 2019

    FDA has approved new warnings about an increased risk of blood clots and of death with the 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR) for treatment of ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe adverse effects with certain other medicatuibs.

    FDA approved these changes, including adding its most prominent boxed warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medication.

    The 10-mg twice-daily dose of tofacitinib is not approved for RA or psoriatic arthritis (PsA). This dose is only approved for ulcerative colitis for initial treatment and for long-term use in limited situations. While the increased risks of blood clots and of death were seen in patients taking this dose for RA, these risks may also apply to those taking tofacitinib for ulcerative colitis.

    Tofacitinib was first approved in 2012 to treat adult patients with RA who did not respond well to methotrexate. In 2017, FDA approved the drug to treat patients with PsA who did not respond well to methotrexate or other similar medications. In 2018, FDA approved tofacitinib to treat ulcerative colitis.

    Health professionals should discontinue tofacitinib and promptly evaluate patients who have symptoms of thrombosis. Counsel patients about the risks, and advise them to seek medical attention immediately if they experience any unusual symptoms, including sudden shortness of breath, chest pain that worsens with breathing, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm.

    Tofacitinib should be reserved for treatment of ulcerative colitis in patients who experienced treatment failure with tumor necrosis factor (TNF) blockers or could not tolerate them. Patients with a higher risk of thrombosis should not use the agent. For treatment of ulcerative colitis, tofacitinib should be used at the lowest effective dose, and the 10-mg twice daily dosage limited to the shortest duration needed.

  • July 24, 2019

    Bayer is voluntarily recalling two lots (27118RK and 27119CG) of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment Jivi antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

    The affected lots were distributed from February 5, 2019, to July 15, 2019, from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS.

    While the majority of the mislabeled vials in the affected lots were recovered, approximately 990 of these vials were released in the United States. The associated Jivi batch was expired as of August 2018. However, all stability specifications of this expired Jivi batch had continued to be met as of April 2019.

    The United States is the only country where affected products were distributed. Bayer said it is working closely with FDA to manage the recall and to minimize disruption to supply and inconvenience to patients. 

     

  • July 24, 2019

    Becton Dickinson is recalling Alaris infusion sets due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a "running status." The firm has determined that the silicone segment of the affected administration set has nonuniform thickness. Nonuniform wall thickness can lead to nonuniform tubing collapse and can contribute to a failure to fully occlude the tubing.

    This device defect may cause serious adverse health consequences for patients, including death. This recall has been associated with MDR reports, several of which are associated with serious injuries.

     

  • June 25, 2019

    On June 21, CDC announced a 3- to 10-month nationwide shortage of Aplisol (Par Pharmaceuticals), one of two purified-protein derivative (PPD) tuberculin skin test antigens licensed by FDA for use in performing tuberculin skin tests. The manufacturer notified CDC that it anticipates an interruption of supply of Aplisol 5 mL (50 multidose vials) beginning in June 2019, followed by an interruption of the supply of Aplisol 1 mL (10 multidose vials) in November 2019. The expected shortage of Aplisol 1 mL could occur before November 2019 if demand increases before then.

    Two types of immunological methods (tuberculin skin tests [TSTs] and interferon-gamma release assay [IGRA] blood tests) are used for detecting Mycobacterium tuberculosis infection. TSTs and IGRAs are used for the diagnosis of latent TB infection and can aid in the diagnosis of TB disease, but additional evaluation and testing are necessary to distinguish between latent TB infection and TB disease to determine the appropriate treatment. When findings such as chest radiography and mycobacterial cultures are sufficient for confirming or excluding a TB diagnosis, the results from a TST or an IGRA blood test might not be needed. However, most TB cases in the United States are diagnosed through a combination of findings, including results from one of these tests. When TB disease is strongly suspected, specific treatment should be initiated, regardless of results from TST or an IGRA blood test.

    CDC recommends the following three general approaches to mitigate a reduction in TB testing capability resulting from the expected shortage of Aplisol:

    • Substitute IGRA blood tests for TSTs. Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different from the criteria for interpreting TSTs.

    • Substitute Tubersol (the other PPD tuberculin antigen approved by FDA), for Aplisol for skin testing. In studies, the two skin test products give similar results for most patients.

    • Prioritize allocation of TSTs, in consultation with state and local public health authorities. Prioritization might require deferring testing for some persons. CDC recommends testing only for persons who are at risk for TB. Groups at high risk for TB infection include 1) persons who are recent contacts exposed to persons with TB disease; 2) those born in or who frequently travel to countries where TB disease is common; 3) those who currently or previously lived in large group settings (such as homeless shelters or correctional facilities); 4) persons with compromised immune systems, including those with health conditions or taking medications that might alter immunity; and 5) children, especially those older than 5 years, if they are in one of the risk groups noted above.

     

  • June 13, 2019

    In a June 30 statement, FDA warned pregnant women and women who could become pregnant not to take dietary supplements containing vinpocetine because it is associated with adverse reproductive effects. FDA has determined that vinpocetine may cause a miscarriage or harm fetal development.

    These findings are particularly concerning because products containing vinpocetine are widely available for use by women of childbearing age. FDA is also advising firms marketing dietary supplements containing vinpocetine to evaluate their product labeling to ensure that it provides safety warnings against use by pregnant women and women who could become pregnant.

    Vinpocetine is a synthetically produced compound that is used in some products marketed as dietary supplements, either by itself or combined with other ingredients. Vinpocetine may be referred to on product labels as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract. Dietary supplements containing vinpocetine are often marketed for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss.

    Scientists who have studied the effects of vinpocetine on pregnant animals concluded that vinpocetine decreased fetal weight and increased the chances of a miscarriage. The blood levels of vinpocetine measured in the pregnant animals were similar to those reported in people after taking a single dose of vinpocetine, indicating that pregnant women may experience adverse effects from vinpocetine similar to those seen in the pregnant animals.

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