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Introduction to News-Multiplex.com
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Leflunomide is known to be embryotoxic and teratogenic in rodents. There are the risk of major
congenital malformation (MCM), prematurity, low birth weight (LBW) and spontaneous
abortion associated with leflunomide exposure during pregnancy in humans.
General recommendations -
If a woman takes prescription or nonprescription medications for RA, these should be reviewed
with a healthcare provider. Some medications are safe during pregnancy while others are not. In
some cases, an alternate medication can be substituted for an unsafe drug.
●Women who take methotrexate should stop it at least one month before trying to conceive,
although the manufacturer suggests discontinuation of this medication three full menstrual cycles
before attempting pregnancy. This waiting period is necessary to allow the effects of
methotrexate on the body to pass so that it will be safe to become pregnant.
●Women who take leflunomide must stop it for at least two years before trying to conceive,
unless a course of treatments to eliminate the drug from the body is used.(
https://www.uptodate.com/contents/rheumatoid-arthritis-and-pregnancy-beyond-the-basics)
In healthy adults, it takes about 10 weeks (2 and 1/2 months) on average after the last
leflunomide dose for most of the drug to be gone from the body. However, the manufacturer of
Arava® says that for some people it could take up to two years for the drug to leave the
body(https://www.ncbi.nlm.nih.gov/books/NBK582787/)

Hydroxychloroquine is known to cause a maculopathy in a number of cases, dependent on dose,

body mass and duration of treatment. Recent data from US suggests a prevalence of 7.5% when
diagnosed using either central visual fields or SD-OCT. New RCOphth guidelines require both
fields and SD-OCT to be abnormal to diagnose hydroxychloroquine
retinopathy(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7316164/)

Long-term use of hydroxychloroquine may result in retinopathy characterized by parafoveal

retinal damage . The clinical picture is classically characterized as a bilateral “bull's-
eye” maculopathy; visual acuity generally remains intact until more severe damage has been
realized. As retinopathy progresses, the area of functional deficit may expand to the foveal center
with decreased visual acuity, peripheral vision, and night vision; cystoid macular edema may
also occur. Clinicians should note that some patients may not experience symptoms during the
early stages of retinopathy and that retinopathy is irreversible
Mechanism: Time-related; exact mechanism is not fully understood. A proposed mechanism is
impaired lysosomal degradation of photoreceptor outer segments by the retinal pigment
epithelium
Onset: Delayed; most commonly occurring >5 years after initiation of therapy .
Risk factors:
• High daily doses relative to body weight (≥5 mg/kg actual body weight) and a duration of >5
years of use in the treatment of rheumatic diseases
• Higher serum concentrations of hydroxychloroquine
• Concurrent tamoxifen use
• Kidney impairment
• Lower body weight
• Preexisting macular disease
Source-(https://www.uptodate.com/contents/hydroxychloroquine-drug-information?
search=hydroxychloroquine%20side%20effects&topicRef=7964&source=see_link#F54441455)
American College of Rheumatology, American Academy of Dermatology, Rheumatologic
Dermatology Society, and American Academy of Ophthalmology 2020 joint statement on
hydroxychloroquine and retinal toxicity

Prevalence of hydroxychloroquine retinopathy reported to range from 4.3% to 13.8%

 dose ≤ 5 mg/kg (based on actual body weight) reported to have low risk of
toxicity (toxic effects reported to develop in < 2% of patients using
hydroxychloroquine for up to 10 years)
 risk of retinopathy reported to increase to about 10% with higher average
daily dose after 10 years, and risk increases with longer duration of use
 in patients with a normal screening exam, the risk of developing
retinopathy in the following year is low (< 5%), even after 20 years of use
 Risk factors for retinopathy include
o high daily dosage relative to body weight
o high cumulative dose of hydroxychloroquine
o concomitant use of tamoxifen
o reduced renal function
 Characteristics of hydroxychloroquine retinopathy
o classically described as a “bull’s-eye” lesion in the macula, which spares the
foveal center; however, visible damage (assessed with ophthalmoscope), which
represents advanced stage of disease, is rare given earlier detection of damage
with modern retinal scanning techniques
o early changes (detectable with optical coherence tomography [OCT]) typically
include
 thinning of retinal layers
 mild disruption of critical areas of the retina (such as the ellipsoid zone)
o retinal changes can also appear initially along the pericentral vascular arcades in
many patients, particularly East Asian patients; screening should include tests that
reach beyond the central macula in this particular subset of patients(Reference
- Arthritis Rheumatol 2021 Jun;73(6):908)