Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding
503A
July 30, 2018
The use of cesium poses significant safety risks (e.g., heart toxicity) and is potentially associated with death. Cesium chloride (CsCl) can cause irregular heartbeats, also called arrhythmias. There have been reports of humans experiencing serious heart problems after taking CsCl. CsCl is associated with a lower blood level of potassium, which is a mineral that is essential to normal heart function.
503B
October 5, 2022
Chloral hydrate presents significant safety risks related to dosing errors, oversedation, and other adverse events including death, especially in the pediatric population.
503A
October 27, 2015
Domperidone is associated with a serious risk of life-threatening cardiac arrhythmias and sudden cardiac death in all populations, including healthy lactating women. Domperidone is transferred into human breast milk, but it is unknown to what extent domperidone in breast milk is absorbed by the breastfed infant and what the resulting drug levels and drug side effects in the exposed infant would be.
Domperidone is available to treat certain gastrointestinal conditions that are refractory to standard treatment under an expanded access investigational new drug (IND) program.
503A; 503B
June 9, 2016
Germanium sesquioxide is likely to be contaminated with highly toxic inorganic forms of germanium salts which can be toxic to the kidneys. Germanium has resulted in nephrotoxicity (kidney injury) and death, even at recommended use levels.
Quinacrine HCl for intrauterine administration
503A; 503B
503A: June 9, 2016
503B: June 7, 2021
Quinacrine HCl is a known mutagen (causes changes in the DNA of a cell) and is associated with serious adverse reactions such as aplastic anemia, hepatitis, severe dermatitis, exacerbation or worsening of psoriasis, and psychosis. Safety risks associated with intrauterine administration of quinacrine HCl (e.g., for female sterilization) include increased risk for life-threatening reproductive tract malignancies.
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