Renal risks of sodium phosphate tablets for colonoscopy preparation: a review of adverse drug reactions reported to the US Food and Drug Administration

AbstractGuided by the principle of primum non nocere (first do no harm), we report a cautionary note on the potential fatal toxicity of chloroquine (CQ) or hydroxychloroquine (HCQ) in combination with anti-diabetic drug metformin. We observed that the combination of CQ or HCQ and metformin, which were used in our studies as potential anti-cancer drugs, killed 30-40% of mice. While our observations in mice may not translate to toxicity in humans, the reports that CQ or HCQ has anti-COVID-19 activity, the use of CQ resulting in toxicity and at least one death, and the recent Emergency Use Authorization (EUA) for CQ and HCQ by the US Food and Drug Administration (FDA) prompted our report. Here we report the lethality of CQ or HCQ in combination with metformin as a warning of its potential serious clinical toxicity. We hope that our report will be helpful to stimulate pharmacovigilance and monitoring of adverse drug reactions with the use of CQ or HCQ, particularly in combination with metformin.

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Food and Drug Administration monitoring of adverse drug reactions

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/43.11.2764 ◽

1986 ◽

Vol 43 (11) ◽

pp. 2764-2770 ◽

Cited By ~ 1

Author(s):

Judith M. Sills ◽

L. Ann Tanner ◽

Julie B. Milstien

Keyword(s):

Adverse Drug Reactions ◽

Drug Administration ◽

Food And Drug Administration ◽

Drug Reactions

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Adverse Drug Reactions and the Food and Drug Administration

Journal of Pharmacy Practice ◽

10.1177/089719008900200403 ◽

1989 ◽

Vol 2 (4) ◽

pp. 209-213 ◽

Cited By ~ 10

Author(s):

Kay C. Pearson ◽

Dianne L. Kennedy

Keyword(s):

Adverse Drug Reactions ◽

Drug Administration ◽

Health Care Providers ◽

Food And Drug Administration ◽

Improve Patient Care ◽

The United States ◽

Care Providers ◽

Drug Reactions ◽

Us Government ◽

Government Work

The monitoring of adverse drug reactions (ADRs) after a drug is marketed is an important mission for the US Food and Drug Administration (FDA). Currently, the FDA receives and computerizes nearly 60,000 ADR reports each year. The FDA has an active postmarketing surveillance system in place to effectively triage, tabulate, analyze, and evaluate these reports. Of highest priority to FDA are the discovery of serious reactions that were not observed before a drug was marketed and the detection of increased occurrence of serious reactions that are known to occur with the drug. All reactions for new moieties marketed in the United States during their first 3 years are of interest. Pharmacists are in a unique position to be aware of adverse reactions because of their knowledge of drugs, their close working relationships with other health care providers, and their direct interactions with patients. By participating in FDA's ADR reporting system, pharmacists can actively contribute to drug safety and help improve patient care. This is a US government work. There are no restrictions on its use.

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