Medication Monitor



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  • March 28, 2019

    FDA is alerting health professionals, oncology clinical investigators, and patients about the risks associated with the investigational use of venetoclax for treatment of patients with multiple myeloma. The agent is not approved for treatment of multiple myeloma.

    FDA reviewed data from the BELLINI clinical trial evaluating the use of venetoclax combined with bortezomib, a proteasome inhibitor, and dexamethasone in patients with multiple myeloma. The interim trial results demonstrated an increased risk of death for patients receiving venetoclax, compared with the control group. On March 6, 2019, FDA required that no new patients be enrolled in the trial. Patients who are receiving clinical benefit can continue treatment in the trial after they reconsent.

    This statement does not apply to patients taking venetoclax for an approved indication, who should continue to take their medication as directed by their health professional. Venetoclax is safe and effective for its approved uses.

    FDA suspended enrollment in other ongoing multiple myeloma clinical trials of venetoclax. Patients who are receiving clinical benefit can continue treatment in these trials after they reconsent.

    FDA said it will be working directly with sponsors of venetoclax, as well as other investigators conducting clinical trials in patients with multiple myeloma, to determine the extent of the safety issue. The agency will communicate any new information as appropriate.

  • March 28, 2019

    Ata Int. Inc. is voluntarily recalling all lots within expiry of Blue Fusion capsules because the product is tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.

    Sildenafil and tadalafil are FDA-approved drugs for treatment of male erectile dysfunction and are phosphodiesterase (PDE-5) inhibitors. Desmethyl carbodenafil and dithiodesmethyl carbodenafil are analogues of PDE-5 inhibitors and are likely to have the same pharmacological activity as PDE-5 inhibitors and thus carry the same clinical risks. Scutellarin and daidzein are derived from plants or herbs.

    Presence of the undeclared active ingredients renders the product an unapproved drug for which safety and efficacy have not been established; therefore, the product is subject to recall.

    Consumption of a product with undeclared PDE-5 inhibitors may pose a threat because the active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels, which can be life threatening. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. 

    Blue Fusion capsules were marketed as a dietary supplement for male enhancement and are packaged in 1-count blister packs (UPC code – 7.48252. 66460.0). The product was distributed nationwide between January 2015 and March 2019 to retail stores and through the internet.

    To date, Ata Int. Inc. has not received any reports of adverse events related to this recall.

  • March 27, 2019

    Mylan Institutional is conducting a voluntary nationwide recall of two lots of levoleucovorin injection (#67457-601-30 and #67457-601-30), 250 mg/25 mL, to the consumer/user level. The lots, manufactured by Alidac Pharmaceuticals and distributed by Mylan, contain particulate matter identified as copper salts. The particulate matter was discovered during 12-month stability testing.

    I.V. administration of a solution containing particulates could lead to local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.

    Levoleucovorin injection is indicated for rescue after high-dose methotrexate therapy in osteosarcoma; for diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdose of folic acid antagonists; and for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

    Levoleucovorin injection 250 mg contains 25-mL sterile solution in a single-use vial. Each vial is packaged in a carton containing one single-use vial. The batches were distributed in the United States between August 2017 and July 2018.

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

  • February 27, 2019

    Golean Detox USA is voluntarily recalling all lots within expiry of Golean Detox capsules, marketed as a dietary supplement for weight loss. An FDA analysis found that the capsules contain undeclared sibutramine and phenolphthalein.

    Sibutramine is an appetite suppressant that was withdrawn from the U.S. market because of safety concerns. Phenolphthalein was once an ingredient used in OTC laxatives, but because of concerns about carcinogenicity, it is not currently approved for marketing in the United States.

    Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Health risks of ingesting phenolphthalein could include potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use. These products may also interact in life-threatening ways with other medications a consumer may be taking. 

    The product is packaged in 14 packets containing two capsules per packet, a total of 28 capsules per box (UPC 8 938510 909013), and was sold nationwide to customers on Facebook at www.goleandetoxus.com.

    The company is notifying its customers and is arranging for return of all recalled products. To date, Golean Detox USA  has not received any reports of adverse events related to this recall.

  • February 26, 2019

    FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10-mg twice-daily dose of tofacitinib was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10-mg twice-daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis.

    In this ongoing safety trial required by FDA when it approved tofacitinib for RA, the drug manufacturer, Pfizer, is transitioning patients who were on the high 10-mg twice-daily dose to the lower, currently approved dose of 5 mg twice daily. This trial will continue and is expected to be completed by the end of 2019. FDA said it is working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on its ongoing review.

    Health care professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating. Monitor patients for the signs and symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they experience them.

    Patients should not stop or change their dose of tofacitinib without first talking to their health care provider, as doing so may worsen their condition. Patients taking tofacitinib should seek medical attention immediately if they experience symptoms of a blood clot in their lungs or other unusual symptoms, such as sudden shortness of breath or difficulty breathing, chest pain or pain in your back, coughing up blood, excessive sweating, or clammy or bluish colored skin.

    Tofacitinib was first approved in 2012 to treat adult patients with RA who did not respond well to the medicine methotrexate. In 2018, FDA approved tofacitinib to treat ulcerative colitis.

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