Gamma hydroxy butyrate (GHB) sold in health food stores has recently caused outbreaks of gastrointestinal illness, central-nervous-system (CNS) depression, and seizures.

The FDA has approved a new IV formulation of dantrolene (Ryanodex – Eagle) for prevention and treatment of malignant hyperthermia in adults and children. The new formulation requires fewer vials, less fluid volume, and less time for preparation and administration than other available IV dantrolene products (Dantrium, Revonto).

Obecabtagene autoleucel (Aucatzyl – Autolus), a CD19-directed genetically modified autologous T cell immunotherapy, has been approved by the FDA for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. The CAR T-cell immunotherapy products tisagenlecleucel (Kymriah) and brexucabtagene auto-leucel (Tecartus) were approved earlier for the same indication.

The US Food and Drug Administration recently approved the marketing of goserelin acetate (Zoladex - ICI Pharma), an implant for palliative treatment of advanced prostate cancer. Goserelin acetate is a synthetic decapeptide luteinizing hormone-releasing hormone (LH-RH) analog similar to leuprolide (Lupron; Lupron Depot) (Medical Letter, 27:71, 1985).

Ropivacaine (Naropin - Astra), like bupivacaine (Marcaine, and others), is a member of the mepivacaine (Carbocaine, and others) family of local anesthetics. Bupivacaine has been an effective long-acting local anesthetic, but with overdosage or inadvertent intravascular injection, it can cause severe cardiotoxicity, which may not be reversible. Ropivacaine is claimed to be less cardiotoxic. It has been approved by the FDA for local or regional block for surgery, obstetrical procedures and postoperative pain management.

Six years after an FDA advisory committee recommended development of a combination tablet containing an oral contraceptive and folic acid,1 the FDA has approved Beyaz (Bayer), a combination of the oral contraceptive Yaz2 with 451 mcg of levomefolate calcium, the primary metabolite of folic acid.3 According to the FDA, an unpublished double-blind, randomized U.S. trial in 379 healthy women 18-40 years old found that the combination increased serum folate levels. In an unpublished German study using a similar oral contraceptive/ levomefolate combination (summarized in the package insert), folate...

Exagamglogene autotemcel (Casgevy – Vertex), a cell-based gene therapy recently approved for treatment of sickle cell disease1, has now been approved by the FDA for treatment of patients ≥12 years old with transfusion-dependent beta thalassemia. Casgevy is the first gene therapy that uses CRISPR/Cas9 gene-editing technology to be approved in the US for any disorder. Betibeglogene autotemcel (Zynteglo), an autologous lentiviral vector cell-based gene therapy, was approved in the US in 2022 for treatment of transfusion-dependent beta thalassemia.

Cytomegalovirus immune globulin (CMVIG) for intravenous administration is now available in the USA on an investigational basis (FE Young and SL Nightingale, JAMA, 260:224, July 8, 1988) for prevention of cytomegalovirus (CMV) infection in CMV-seronegative renal transplant recipients who receive a kidney from a seropositive donor. CMVIG contains IgG antibodies from a pool of healthy donors with high titers of antibodies against CMV. The drug can be obtained from the Massachusetts Department of Public Health Biologic Laboratories (617-522-3700, extension 264) or the American Red Cross...

Many readers have asked the Medical Letter to evaluate St. John's wort, an herbal extract now widely sold in health food stores and pharmacies, for its effectiveness and safety in the treatment of depression. St. John's wort is licensed in Germany for treatment of anxiety, depression and insomnia. In the USA, it is considered a dietary supplement and has not been evaluated by the FDA.

Finasteride and minoxidil continue to be the only drugs approved by the FDA to treat alopecia. Since these agents have different mechanisms of action, some clinicians have used both to treat hair loss in men.