Medication Monitor

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Generic Name (Trade Name—Company)
  • May 1, 2019

    AmEx Pharmacy is voluntarily recalling one lot (#190212AB, BUD 5/13/2019) of bevacizumab 1.25 mg/0.05 mL 31G injectable to the consumer/user level. The monoject syringe of this product may become difficult to express, and the additional force needed to express the drug product could result in damage to the eye while the needle is in the eye. 

    The product is used for wet age-related macular degeneration and diabetic retinopathy. It is individually wrapped and labeled in a Tyvek pouch, which is then placed in a labeled amber bag to protect from light. The lot number appears prominently on all labeling. The lot was distributed to ophthalmologist clinics in Pennsylvania, Illinois, Texas, Wisconsin, Kansas, Tennessee, Indiana, and Arizona.

    To date, AmEx Pharmacy has received three reports, two of which resulted in an adverse drug event.

  • April 25, 2019

    On April 11, 2019, FDA announced that changes must be made to the labeling for flibanserin to clarify that there is still a concern about consuming alcohol close in time to taking the drug, but that alcohol does not have to be avoided completely.

    Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least 2 hours before taking flibanserin at bedtime or to skip the flibanserin dose that evening. Women should not consume alcohol at least until the morning after taking flibanserin at bedtime.

    FDA is ordering this safety labeling change because the agency was not able to reach an agreement with the manufacturer, Sprout Pharmaceuticals. The company was continuing to request removal of the boxed warning and contraindication about alcohol completely from the product labeling. FDA determined, based on a careful review of available data, that to protect public health, removing this important safety information was not acceptable.

    The agency's decision to order modifications to the warnings about flibanserin and alcohol, instead of removing the boxed warning and contraindication completely, was based on two sets of postmarket research studies.

    Flibanserin is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. The drug is taken once daily at bedtime to help decrease the risk of adverse events from possible hypotension, syncope, and CNS depression (such as sleepiness and sedation). Patients should stop treatment after 8 weeks if they do not have an improvement in sexual desire and associated distress.

    The drug's most common adverse reactions are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.

  • April 25, 2019

    Alvogen is voluntarily recalling two lots (#180060 and #180073) of 12-mcg/h fentanyl transdermal patches because a small number of cartons were found to contain 50-mcg/h patches. The 50-mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. The transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN.

    Application of a 50-mcg/h patch instead of a prescribed 12-mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential increased risk could include first-time recipients of such patches, children, and older adults. 

    The product is indicated for management of pain in opioid-tolerant patients and is packaged in primary cartons of five individually wrapped and labeled pouches. 

    Alvogen is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Pharmacies should not dispense any product subject to this recall. Patients who have the product should immediately remove any patch currently in use, contact their health care provider, and return the unused product to point of purchase for replacement.

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

  • 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.