Medication Monitor

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  • April 25, 2019

    SD Import is voluntarily recalling all lots of aphrodisiac capsules to the consumer level. An FDA analysis found the product is tainted with sildenafil, an FDA-approved active pharmaceutical ingredient (API) used to treat erectile dysfunction. Presence of the sildenafil renders the capsules an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

    Consumers with diabetes, hypertension, high cholesterol, or heart disease often take nitrates; consumption of undeclared sildenafil along with nitrates could result in a drop in blood pressure that is life-threatening and could result in serious adverse health consequences. 

    Aphrodisiac capsules are marketed as a dietary supplement for men for sexual enhancement and are packaged in a cardboard box with 12 plastic packs in a box (UPC Code 644118128135). The product was distributed nationwide to retail stores and a variety of online websites.

    SD Imports is notifying its distributors and customers by e-mail and arranging for return of all recalled products.

    The company indicated that, to date, it has not received any reports of adverse events related to this recall.

  • April 24, 2019

    FDA announced that it has received reports of serious harm in patients who are physically dependent on opioid pain medications when these medications are discontinued or the dose is rapidly decreased. Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms, psychological distress, and suicide. Patients may seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse, or attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

    Health professionals should not discontinue opioids abruptly in a patient who is physically dependent. When tapering, consider a variety of factors, including the dose, treatment duration, type of pain being treated, and a patient's physical and psychological attributes. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose, and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress.

    FDA is tracking this safety concern as part of its ongoing monitoring of risks associated with opioid pain medications. In addition, it is requiring changes to the prescribing information that will provide expanded guidance to health professionals on how to safely decrease the dose in patients who are physically dependent on opioids. The new labeling will include additional information on other adverse effects of opioids, such as central sleep apnea and drug interactions, and on proper storage and disposal of these medications.

    The agency is urging patients and health professionals to report adverse effects involving opioids to the FDA MedWatch program.

  • 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.