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PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLETS: TOXICOLOGY

Only limited preclinical data are available for Plaquenil (Hydroxychloroquine Sulfate), therefore chloroquine data are considered due to the similarity of structure and pharmacological properties between the 2 products.

Genotoxicity

There are limited data on hydroxychloroquine genotoxicity.

Chloroquine is reported in the literature to be a weak genotoxic agent which may elicit both gene mutations and chromosomal/DNA breaks. Mechanisms may involve DNA intercalation or induction of oxidative stress. Positive and negative results in in vitro reverse gene mutation assays using bacteria (Ames test) and in in vivo studies using rodents (mouse bone marrow cell sister chromatid exchange, mouse bone marrow cell chromosome abnormality, and rat DNA strand-breaks in multiple organs when animals were dosed by intraperitoneal route).

Carcinogenicity

There are no data on Hydroxychloroquine (Plaquenil) carcinogenicity from animal studies and insufficient data on carcinogenicity is available for chloroquine. Both drugs are not classifiable as to their carcinogenicity to humans.

Reproductive and developmental toxicity

There are limited data on hydroxychloroquine teratogenicity.
Supratherapeutic doses of chloroquine resulted in a fetal mortality rate of 25% and ocular malformations in 45% of fetuses. Autoradiographic studies have shown that when administered at the start or the end of gestation, chloroquine accumulates in the eyes and ears.

There are no data on hydroxychloroquine action on fertility.
A study in male rats after 30 days of oral treatment at 5 mg/day of chloroquine showed a decrease in fertility rate, testosterone levels, weight of testes, epididymis, seminal vesicles and prostate, and caused production of abnormal sperm.

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