The FDA has approved the use of an equine heptavalent botulism antitoxin (BAT, Cangene Corporation). The new antitoxin includes antibodies against all 7 botulinum neurotoxin types (A-G). A human-derived antitoxin (BabyBIG) has been available for years for infant botulism. The heptavalent product is now the preferred antitoxin for adult botulism. It is a solution of immunoglobulin fragments obtained from equine plasma that has gone through several steps of purification and viral inactivation. (The use of immunoglobulin fragments reduces side effects compared to intact...

On August 6, 2019, the FDA issued a statement on data manipulation/inaccuracy issues with Zolgensma, a virus vector-based gene therapy approved for one-time IV treatment of children <2 years old with spinal muscular atrophy.1 We reviewed Zolgensma in our July 29 issue.2 According to the FDA statement, the manipulated data pertained to the production process for the product and did not affect the efficacy or safety results from the human clinical trials. It does not require any change in our review.FDA Statement. Statement on data accuracy issues with recently approved gene therapy....

FluMist (AstraZeneca), the live-attenuated intranasal influenza vaccine that has been available for years for administration by a healthcare provider in nonpregnant persons 2-49 years old, has now been approved by the FDA for self- or caregiver-administration. It is expected to be available for such use during the 2025-2026 influenza season. FluMist is only available through a healthcare provider this season. It will continue to be available for administration by a healthcare provider in the future

With the deployment of hundreds of thousands of troops in Saudi Arabia, health problems endemic to the Arabian Peninsula may be coming to the attention of physicians in the USA and other areas.

Aspirin is now widely used for antithrombotic prophylaxis in patients who have had angina pectoris or a myocardial infarction and has also been tried in healthy people to prevent myocardial infarction. Recent studies have focused on increasingly lower doses of the drug. The use of aspirin in patients who have had transient ischemic attacks or strokes will not be discussed here.

The number of cough remedies available in the USA continues to multiply, but most products contain the same or similar ingredients in varying combinations. Most acute coughs do not require treatment with drugs, especially in children, and suppression of a productive cough may be harmful.

Recently published guidelines from the American Diabetes Association (ADA) and the Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group recommend addition of the oral nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone (Kerendia) to standard treatment in patients with type 2 diabetes and chronic kidney disease (CKD).

The FDA has licensed Capvaxive (PCV21; Merck), a 21-valent pneumococcal conjugate vaccine, for prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults. Four other pneumococcal vaccines are currently available in the US: Prevnar 20 (PCV20), Vaxneuvance (PCV15), and Prevnar 13 (PCV13) are conjugate vaccines licensed for use in persons ≥6 weeks old, and Pneumovax 23 (PPSV23) is a pneumococcal polysaccharide vaccine licensed for use in persons ≥2 years old (see Table 1).

The FDA has announced that the single 32-mg IV dose of ondansetron (Zofran, and generics) used for prevention of cancer chemotherapy-associated nausea and vomiting has been withdrawn from the market because it can prolong the QT interval and could possibly cause a torsades de pointes cardiac arrhythmia. For this indication, the only recommended dose of IV ondansetron is 0.15 mg/kg (maximum 16 mg/dose) every 4 hours for 3 doses. There are no changes in the recommended dosing regimens for oral ondansetron or for IV ondansetron used for prevention of postoperative nausea and vomiting.Download...

(Kodak) perform clinical chemistry tests using desk-top instruments, microliter samples and postage-stamp-sized analytical slides containing dry reagents layered on clear polyester and mounted in plastic. The system requires no wet reagents, except for electrolyte determinations, and is designed to require a minimum amount of training to operate. A single analysis takes about five minutes.