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Off Label Medication and Use of Unapproved Drugs

Prashanthi Gummadi

Off-label means the medication is being used in a way not specified in the approved packaging label. Every prescription drug has an approved individual label for that particular disease it’s meant for. This label is a written format that helps in providing detailed directions and instructions regarding the approved uses and doses based on clinical studies that the drug manufacturer submits to the FDA before the manufacturing begins. Off-label drug use has been recognised as one of high risk drug prescribing because of lack of necessary information regarding safety of drug and its effectiveness. Even though sometimes Off-label prescribing is good and it’s beneficially in treating different disorders, especially when all other approved drug use by particular patient has shown tolerance and there is no other option of treating patient with approved drugs. For this review the data was compiled in a format for better understanding of the off label use of drugs both by physicians and pharmacist. Some of the drugs used for off label purpose includes Minoxidil which is a Vasodilator but is actually also used for hair growth for people suffering from hair loss. Likewise many drugs like Aripripazole, Gabapentin, Amitriptyline, Propranolol, Risperidone, Sildenafil, and Clonidine have off label use which is showcased.