Do not give drug without consent for any off label use
Dr K K Aggarwal
Off label use of drugs is not allowed. Even giving doses
more than the recommended dose by DCGI is also nor permitted. In Dr. Sukumar Mukherjee vs
Dr. Kunal Saha the apex court has observed that “ No doctor has the right to use the drug
beyond the maximum recommended dose. “
Recently the DCGI has agreed to allow use of off label drug
Avastin in eye disorders but after an informed consent by the patient. Any off
label use ifs like a drug trial and needs both ethics committee approval and an
informed consent.
All patients should be told when they are receiving a drug
for off-label use and make an informed decision.
Some examples
1. Asthma
drug theophylline, shows promise in restoring the sense of smell in those who
have lost that precious ability.
2. The
common epilepsy drug, phenytoin, is used to heal wounds as it causes
hypertrophy of the granulation tissue.
3. Nifedipine,
a common blood pressure drug, is now used to pass out small ureteric stones
smaller than 10 mm.
4. Viagra,
the erectile drug, has now been used in the treatment of pulmonary hypertension
in patients with COPD.
5. The SSRI
drug sertraline is approved as an antidepressant. It is also commonly
prescribed off–label to help men suffering from premature ejaculation.
6. Methotrexate,
approved for the treatment of choriocarcinoma, is frequently used for the
medical treatment of an unruptured ectopic pregnancy.
7. Gabapentin,
approved for treatment of fits and post herpetic neuralgia in adults, is used
off–label for bipolar disorder, essential tremors, hot flashes, migraine,
neuropathic pains, phantom limb and restless leg syndrome.
8. Avastin,
the cancer drug in multi dose form, is used in retinal disorders
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