The Food and Drug Administration (FDA) has approved new single-dose prefilled syringes for Emerphed^® (ephedrine sulfate injection) for the treatment of clinically important hypotension occurring in the setting of anesthesia.

The Emerphed prefilled syringes are ready-to-use and require no assembly. The new formulation is available immediately as 25mg/5mL and 50mg/10mL single-dose prefilled syringes in 10-count cartons. 

“We are pleased to announce the addition of our latest Emerphed^® product to our suite of existing FDA-approved, ready-to-use ephedrine sulfate products,” said CEO and President, Usman Ahmed. “These patented products showcase Nexus’ ability to provide innovative therapies that address clinicians’ concerns about delivering efficient and safe medications. With Emerphed^®, we look forward to transforming how patients are treated, while continuing to offer the quality they’ve come to expect.”

Ephedrine sulfate works by directly acting as an alpha- and beta-adrenergic agonist and indirectly causing the release of norepinephrine. Pressor effects by direct alpha- and beta-adrenergic receptor activation are mediated by increases in arterial pressures, cardiac output, and peripheral resistance. Ephedrine sulfate stimulates heart rate and cardiac output and variably increases peripheral resistance, resulting in increased blood pressure. 

Emerphed is also available as 50mg/10mL ready-to-use, single-dose vials in 10-count cartons.

References

1. Nexus Pharmaceuticals, Inc. receives FDA approval for Emerphed^® (ephedrine sulfate injection) pre-filled syringe. News release. Nexus Pharmaceuticals. Accessed March 1, 2023. https://www.businesswire.com/news/home/20230301005543/en/Nexus-Pharmaceuticals-Inc.-Receives-FDA-Approval-for-EMERPHED%C2%AE-ephedrine-sulfate-injection-Pre-Filled-Syringe.
2. Emerphed. Package insert. Nexus Pharmaceuticals; 2023. Accessed March 1, 2023. https://21078818.fs1.hubspotusercontent-na1.net/hubfs/21078818/EMERPHEDPFSPI.pdf.

High-Alert Medications

HealthDay News — Hypotension-avoidance and hypertension-avoidance strategies result in similar incidence of major vascular complications among patients undergoing noncardiac surgery, according to a study published online April 25 in the Annals of Internal Medicine.

Maura Marcucci, MD, from the Population Health Research Institute in Hamilton, Ontario, Canada, and colleagues compared the effects of a hypotension-avoidance and hypertension-avoidance strategy on major vascular complications after noncardiac surgery in a randomized trial. Data were included for 7490 patients in 110 hospitals in 22 countries who had noncardiac surgery, were at risk for vascular complications, and were receiving at least one long-term antihypertensive medication. The hypotension-avoidance strategy group had an intraoperative mean arterial pressure target of 80 mm Hg or greater, while the hypertension-avoidance strategy group had an intraoperative mean arterial pressure target of 60 mm Hg or greater (3742 and 3748 patients, respectively).

The primary composite outcome included vascular death and nonfatal myocardial injury after surgery, stroke, and cardiac arrest at 30 days. The researchers found that the primary outcome occurred in 13.9 and 14.0% of patients in the hypotension-avoidance group and hypertension-avoidance group, respectively. For patients who used one or more than one antihypertensive medication in the long term, results were consistent.

“Further research is needed to identify and evaluate perioperative interventions that can modify hemodynamics to an extent and in the direction that will lead to a favorable effect on major clinical outcomes,” the authors write.

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The recalled IV bags were distributed nationwide to hospitals for administration and include the following item numbers: 

• Fentanyl 1000mcg (10mcg/mL) (as Fentanyl Citrate) PF (from API) added to 0.9% Sodium Chloride 100mL IV bag; Item Number F3355.
• Fentanyl 2500mcg (10mcg/mL) (as Fentanyl Citrate) PF (from API) added to 0.9% Sodium Chloride 250mL IV bag; Item Number F3342.
• Phenylephrine HCl 20mg (80mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250mL IV Bag; Item Number F3360.
• Phenylephrine HCl 40mg (160mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250mL IV Bag; Item Number F3352.
• Vancomycin HCl 1.25g PF added to 0.9% Sodium Chloride 250mL IV Bag; Item Number F3206.
• Vancomycin HCl 1.5g PF added to 0.9% Sodium Chloride 250mL IV Bag; Item Number F3208.

Administration of superpotent IV vancomycin, a glycopeptide antibacterial, or fentanyl, an opioid agonist, can lead to potentially life-threatening adverse events. Moreover, the use of recalled IV phenylephrine, an alpha-1 adrenergic receptor agonist, can lead to higher than intended blood pressure increases. To date, the Company has not received any reports of adverse events related to this recall.

The full list of recalled products, including lot numbers and expiration dates, can be found here. 

Adverse events or quality issues should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program. 

HealthDay News — There is a seasonal effect on systolic blood pressure (SBP), according to a study presented at the American Heart Association Hypertension 2023 Scientific Sessions, held from September 7 to 10 in Boston.

Robert B. Barrett, from the American Medical Association in Greenville, South Carolina, and colleagues assessed the influence of seasonal effects on average SBP. The analysis included 60,676 patients treated at 1 of 6 diverse health care organizations engaged in a quality improvement program.

The researchers found that SBP during winter months averaged 0.47 mm Hg higher than the yearly mean, which was associated with a significantly lower odds ratio for BP control (odds ratio, 0.92). In contrast, during the summer, average SBP was 0.92 mm Hg lower, with a higher likelihood of BP control (odds ratio, 1.10).

“Despite the smaller degree of systolic blood pressure variation in comparison to previous studies on seasonality in blood pressure, we were surprised to observe a large degree of change in blood pressure control between winter and summer months,” Barrett said in a statement. “Individuals with hypertension or values near the range of hypertension may benefit from periodic blood pressure monitoring and improvements in physical activity and nutritional patterns during winter months to offset adverse effects from seasonal blood pressure changes.”

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