Medication Monitor

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  • May 2, 2019

    Sagent Pharmaceuticals announced a voluntary nationwide recall of one lot (#M813513) of ketorolac tromethamine injection USP 60 mg/2 mL (30 mg per mL) because microbial growth was detected during a routine simulation of the manufacturing process. This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent. 

    Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue.

    The product is a NSAID indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. It is supplied in 2-ml glass tubular vials. The lot number being recalled was distributed to hospitals, wholesalers, and distributors nationwide from January to March 2019.

  • May 1, 2019

    FDA is warning that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than with other prescription medicines used for sleep.

    If patients experience a complex sleep behavior during which they engage in activities while they are not fully awake, or do not remember activities they have done while taking the medicine, they should stop taking their insomnia medication and contact their health professional right away.

    Health professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Health professionals should advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death, and they should discontinue taking these medicines if they experience an episode of complex sleep behavior.

  • 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.