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Editorial 
 

Off The Label - Not Uncommon 
 

In the field of medicine including ophthalmology 
since a long while there has been a practice to use an 
approved drug for an indication not approved by the 
regulating authorities i.e. off the label use. 

This trend is becoming more wide spread in 
ophthalmic practice all over the world like the use of 
intravitreal: 

• antibiotics (for prevention and cure of 
endophthalmitis) 

• Steroids (triamcilone acctonide for situations 
like venous occlusions, uveitis, diabetic 
macular edema etc) 

• Anti HIV drugs as injections or slow release 
inserts 

• Various gases and temponading materials 
and chemo therapeutic adjuncts like 5FU 
with heparin during vitreo-retinal surgery. 

• Lately the rampant use of Avastin (an anti 
V.E.G.F. branded as magic drug for 
varculopathic conditions like S.M.D, diabetic 
retinopathy, rubiosis iridis and similar other 
conditions. 

We have also been using many off the label other 
drugs routinely for example mitomycin and 5FU in 
glaucoma filtering surgery, during pterygium 

operations and refractive surgery procedures like 
P.R.K. etc. 

When approved therapy fails or is not affordable, 
the use of off the label drugs as salvage therapy 
makes it a standard of care, gradually adopted as 
primary therapy and after a while is even thought off 
as legal and necessary part of medical practice. All 
said and done still it does not absolve us of liabilities 
and we should be reasonably certain in good faith 
about its efficacy and benefits with no serious risks to 
our patients. 

Let us reemphasize that the sole purpose of the 
use of the off the label drugs is to benefit our patients 
suggested by its reported wide spread use by 
reasonable number of pioneers and colleagues, having 
been also recommended during conferences, 
presentations, writings and clinical trials. 

We should pay special attention to proven 
indications, recommended concentrations and dosage, 
route of administration with due precautions, all the 
time remaining vigilant about any adverse effects. 
 
 

M Lateef Chaudhry 
Editor in Chief 

Pakistan Journal of Ophthalmology