Rezipres Approved to Treat Hypotension in Patients Under Anesthesia

The U.S. FDA has approved Rezipres® (ephedrine hydrochloride injection), manufactured by Eton Pharmaceuticals, to treat clinically important hypotension occurring in the setting of anesthesia.

Hypotension, or low blood pressure, can occur under anesthesia due to factors such as blood loss or anesthesia side effects. It can put patients at risk regardless of whether they receive general anesthesia, in which a patient is unconscious during a procedure, or anesthesia that prevents pain without rendering a patient unconscious, such as an epidural used for C-sections.

In clinical studies, ephedrine produced increases in blood pressure in patients under general anesthesia or neuraxial anesthesia – when local anesthetics are used around the nerves of the central nervous system. Examples of neuraxial anesthesia include epidural, spinal, and caudal anesthesia.

Recommended dosing is an initial dose of 4.7mg to 9.4mg of Rezipres administered by intravenous (IV) bolus (a rapid IV injection) followed by additional boluses as needed. Dosage should be titrated according to the blood pressure goal. Total dosage should not exceed 47mg.

Launch and pricing information are not yet available.

Two Lots of Metformin Recalled Due to NDMA

Viona Pharmaceuticals, Inc., has recalled two lots of Metformin Hydrochloride Extended- Release Tablets, USP 750mg due to the detection of N-nitrosodimethylamine (NDMA) impurities above acceptable daily limits. Cadila Healthcare Limited manufactured the product in November 2019 for Viona to distribute.

NDMA is considered a probable human carcinogen (a substance that could cause cancer) and is a known environmental contaminant found in water and food. According to the recall announcement, patients who may have the affected metformin in their possession should not stop taking their medication without consulting a healthcare professional. The risk of stopping treatment with metformin, which is used to treat type 2 diabetes, may outweigh the risk of potential NDMA exposure. As of the date of the recall, Cadila and Viona had not received reports of adverse events related to the affected product.

Consumers can direct questions regarding the recall to Eversana Life Science Services at 1-888-304-5022 (option 1). They should contact their healthcare provider if they’ve experienced any problems that may be related to using the product and can also direct medical-related questions or report adverse events or quality issues to Viona at 1-888-304-5011. Adverse events can be reported to the U.S. FDA through the agency’s MedWatch program.

A full copy of the recall announcement with details of the affected lots is available on the FDA’s website.

There is no member impact through Benecard Central Fill.