Medication Monitor



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  • 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.

  • June 12, 2019

    Norvartis is voluntarily recalling three lots (8H57901589, 9H57900189, and 9H57900289) of eltrombopag 12.5 mg for oral suspension to the consumer level because of a risk of potential peanut flour contamination.

    Eltrombopag 12.5 mg for oral suspension is indicated for treatment of chronic immune thrombocytopenia, hepatitis C-associated thrombocytopenia, and severe aplastic anemia in certain adult and pediatric patients who have not received prior immunosuppressive therapy or had an insufficient response to immunosuppressive therapy.

    Eltrombopag tablets in 12.5-, 25-, 50-, and 75-mg strengths are not affected by this recall and are not manufactured in the same facility.

    Eltrombopag 12.5 mg for oral suspension was distributed nationwide through specialty pharmacies.

    To date, Novartis has not received any reports or adverse events for this recall.

  • June 12, 2019

    Par Pharmaceutical is voluntarily recalling one lot of mycophenolate mofetil for injection, USP, to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution.

    Administration of a glass particulate, if present in an I.V. drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. 

    Mycophenolate mofetil for injection, USP, is indicated for prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. It should be used concomitantly with cyclosporine and corticosteroids.

    The affected product includes lot AD812, expiry 09/2020. It is packaged in cartons of four single-use vials labeled NDC 42023-172-04 and was distributed nationwide in the United States between January 23, 2019, and February 11, 2019.

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

  • June 12, 2019

    In a May 2, 2019, statement, FDA indicated that several compounding pharmacies and physicians had contacted the agency to determine if compounders can use the bulk drug substance oxitriptan to compound oral drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for an identified patient with tetrahydrobiopterin (BH4) deficiency, a group of rare inborn errors of metabolism.

    The agency has informed these stakeholders that it does not intend to object to the compounding of oral oxitriptan for patients with BH4 deficiency who have a prescription identifying the disorder, as long as the drug is compounded in compliance with all other conditions of section 503A of the FD&C Act.

    This group of disorders is also identified by the names primary tetrahydrobiopterin (BH4) deficiency, atypical phenylketonuria (PKU), or BH4-deficient hyperphenylalaninemia. Patients with 6-pyruvoyl-tetrahydropterin synthase (6-PTPS) deficiency are among those included in this group of disorders.

    On February 19, 2019, FDA issued a final rule that placed six bulk drug substances on the list of bulk drug substances that can be used in compounding under section 503A of the FD&C Act (referred to as the “503A bulks list”) and identified four others, including oxitriptan, that FDA did not place on the 503A bulks list. FDA evaluated oxitriptan, also known as 5-hydroxytryptophan or 5-HTP, for inclusion on the 503A bulks list as a treatment for depression or insomnia and did not include it on the list.

    Patients with BH4 deficiency who have questions should contact their health care provider or contact FDA via druginfo@fda.hhs.gov. Health professionals and compounders with questions about using the bulk drug substance oxitriptan to compound oral drugs for BH4 deficiency under section 503A of the FD&C Act should contact compounding@fda.hhs.gov.

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