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Scynexis Recalls its Antifungal
On Wednesday, Scynexis announced it was conducting a nationwide voluntary recall of its thereapy ibrexafungerp tablets (Brexafemme) to the consumer level in the US market due to potential cross contamination with a non-antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the tablets. Specifically, they are recalling 2 lots.
According to the company, ibrexafungerp is dispensed in a carton and packaged in blister packs with four 150-mg tablets (NDC 75788-115-04). Ibrexafungerp tablet for oral administration is a purple, oval, biconvex shaped, film-coated tablet debossed with 150 on one side and SCY on the other side. The affected Ibrexafungerp lots include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051 (expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US, beginning in December 2022.
Ibrexafungerp is an antifungal indicated for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC). The FDA approved it in June 2021 for this indication. The therapy, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from 2 phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.
In its statement, Scynexis provided a Risk Statement, which said: “The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction. To date, Scynexis has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.”
Scynexis is working with Sedgwick to manage the recall of the product down to the consumer level. Consumers with questions regarding this recall can contact Sedgwick at 1-877-551-7154. Office hours: Monday to Friday, 8:00 AM to 5:00 PM ET.
Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Case of Bubonic Plague
Public health officials in Colorado stated one person who died in Archuleta County had a confirmed case of plague. The Colorado Department of Public Health and Environment (CDPHE) and San Juan Basin Public Health (SJBPH) are investigating the case.
“On behalf of all of us at SJBPH, our hearts go out to the family while we work with CDPHE to conduct a thorough investigation to keep residents safe,” said Tiffany Switzer, interim executive director of SJBPH. “While this disease is very rare, it is important to be aware of how you can be exposed and the symptoms it can cause. If you think you have symptoms consistent with plague, seek health care immediately and let them know you may have been exposed.”
No other information about the person who contracted the disease was provided.
Plague is frequently detected in rock squirrels, prairie dogs, wood rats, and other species of ground squirrels and chipmunks. In their statement, SJBPH said it investigates prairie dog population die-offs for the presence of plague. If an active colony of prairie dogs suddenly disappears, please report this to SJBPH. Residents should not eradicate or kill prairie dogs on their property as this increases the risk of exposure to plague-infested fleas.
Plague is caused by the bacterium, (Yersinia pests), which can be transmitted to humans by the bites of infected fleas or by direct contact with infected animals.
The CDC says clinicians should treat patients right away and not wait for diagnostic tests if they suspect plague.
“The decision to initiate antibiotic therapy for plague should be made based on clinical signs and symptoms and a careful patient history. A recent flea bite, exposure to areas with rodents, or contact with a sick or dead animal are risk factors for plague in endemic areas,” CDC writes on its site.
