Thursday, Fennec Pharmaceuticals Inc. (FENC) disclosed that the FDA's Center for Drug Evaluation and Research has issued a public reminder to healthcare providers regarding the company's Pedmark.
The reminder emphasizes that Pedmark or sodium thiosulfate injection should not be substituted with other sodium thiosulfate or STS products, as stated in its prescribing label.
The FDA highlighted that such substitutions pose potential health risks, including exposure to potassium chloride, overexposure to boric acid, and overexposure to sodium nitrite.
The FDA issued this warning as certain providers may be preparing other STS products for patient use instead of Pedmark.
Pedmark is the first and only FDA-approved therapy indicated to reduce the risk of ototoxicity or permanent hearing loss associated with cisplatin in pediatric patients 1 month of age and older.
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