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FDA approved sodium thiosulfate for pediatric use

Sodium thiosulfate has been approved by the FDA to treat ototoxicity in pediatric patients with localized, non-metastatic solid tumors.

The US Food and Drug Administration (FDA) has approved sodium thiosulfate (Pedmark; Fennec Pharmaceuticals Inc.) for use in pediatric patients aged 1 month and older with localized, non-metastatic solid tumors.

Cisplatin-based chemotherapy is used to treat patients with cancer but is associated with risk of ototoxicity. Sodium thiosulfate has been proven to reduce risk for pediatric patients through 2 multicenter open-label, randomized controlled trials.

In the first trial, 114 patients taking 6 cycles of perioperative cisplatin-based chemotherapy for standard risk hepatoblastoma were randomized to receive the therapy either with or without sodium thiosulfate doses.

Brock Grade ≥1 hearing loss was assessed in patients and compared between groups. The sodium thiosulfate and cisplatin arm had a 39% hearing loss rate, while the cisplatin alone arm had a 68% hearing loss rate.

In the second trial, 125 pediatric patients took a chemotherapy regimen with cumulative cisplatin doses of 200 mg/m2 or higher. Doses were injected over periods of 6 hours or less.

Patients were randomized into 2 groups, one of which was given sodium thiosulfate during chemotherapy while the other was not. Hearing loss was assessed in both groups, with the sodium thiosulfate and cisplatin arm group having lower rates than the cisplatin alone arm group.

Vomiting, nausea, decreased hemoglobin, hypernatremia, and hypokalemia were the most common adverse events in both trials, appearing in 25% of cases of sodium thiosulfate and cisplatin compared to 5% of cases of cisplatin alone.

Doses of sodium thiosulfate are measured based on surface area according to actual body weight. Sodium thiosulfate is administered 15 minutes after cisplatin, with infusions lasting 1 to 6 hours.


FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors. US Food and Drug Administration. September 20, 2022. Accessed September 22, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sodium-thiosulfate-reduce-risk-ototoxicity-associated-cisplatin-pediatric-patients