Recalls and warnings
A class I recall of the Seattle Positive Airway Pressure Plus system and VentStar and other breathing circuit/anesthesia kits by Draeger due to a manufacturing error. Glued connections may loosen before or during ventilation. The recall includes 570,459 devices distributed from Jan. 1, 2019, to Feb. 28, 2023. No related injuries or deaths have been reported.
A class I recall of replacement batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems by ICU Medical due to diminished battery life that may affect infusion delivery. The recall includes 1,904 devices distributed from Feb. 7 to Dec. 22, 2022. The company has received 54 (Plum 360) and 465 complaints (Plum A+/A+3) and has not reported any injuries or deaths; however, the FDA has identified an adverse event that may be related.
Finalized recommendations for individual risk assessment to determine eligibility for blood donations. The policy eliminates time-based deferrals and screening questions specific to men who have sex with men, as well as their female partners. The FDA recommends assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex, or gender. Under the updated policy, all prospective donors who report having anal sex and a new sexual partner or more than one sexual partner in the past three months would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing. Those taking medications to treat or prevent HIV infection will also be deferred, since use of these medications may delay detection of HIV (although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission). The updated policy is based on the best available evidence and aligns with policies in countries like the U.K. and Canada, the FDA said.
Fezolinetant (Veozah) to treat moderate to severe vasomotor symptoms caused by menopause. The nonhormonal oral medication is the first neurokinin 3 (NK3) receptor antagonist approved to treat moderate to severe hot flashes caused by menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain's regulation of body temperature. The most common side effects include abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated hepatic transaminases. The prescribing information includes a warning for elevated hepatic transaminase; patients should have bloodwork done to test for liver damage before starting the drug. Routine bloodwork should be performed every three months for the first nine months of use.
Buprenorphine extended-release injection for subcutaneous use (Brixadi) to treat moderate to severe opioid use disorder. The drug is available in two formulations at varying doses, including lower doses than are currently available: a weekly injection, which can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or those already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine. The weekly doses are 8 mg, 16 mg, 24 mg, and 32 mg, and the monthly doses are 64 mg, 96 mg, and 128 mg. The drug will be available through a Risk Evaluation and Mitigation Strategy program and will be administered only by clinicians in a health care setting. The most common adverse reactions include injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia, and urinary tract infections.
Note: The FDA states that drugs are not always commercially available immediately after approval.