Drugs are often used in ways different from the FDA-approved drug label and this is said to be off-label drug use. The FDA approved label describes the medical condition the drug can be used to treat, the approved doses and other information about the drug. When a drug is used off-label:
- It may be used to treat a different medical condition.
- It may be administered in a different way.
- Drug may be given in a different dose than the approved one.
Even though off-label use of drugs is legal in the US and many other countries, it is unapproved use of a drug. Thus, use of Viagra for enhancing sexual performance is off-label use of the drug and so is the use of cancer drugs for treating a different type of cancer than that it is approved for.
Some Commonly Used Off-Label Class of Drugs
Class of Drug
Examples of Off-Label Use
|Anti-seizure drugs||Migraines, depression, nerve pain|
|Antipsychotics (for Schizophrenia)||Alzheimer’s Disease, autism, dementia, Attention Deficit Hyperactivity Disorder (ADHD)|
|Antidepressants||Chronic pain, ADHD, bipolar disorder|
|Antihistamines (for allergies)||Colds, asthma, ear infection symptoms, as sleep aids|
|Antibiotics||Viral infections, such as common cold or flu, against which antibiotics are useless|
|Anxiety drugs||To ease “normal” life stresses, as sleep aids|
|Proton Pump Inhibitors (for gastroesophageal reflux disease)||Occasional heartburn, indigestion, irritable bowel|
|Beta-Blockers (for high blood pressure and heart disease)||Migraines, heart rhythm disorders, anxiety|
|Drugs to treat Attention Deficit Hyperactivity Disorder||For people not diagnosed with ADHD, to enhance alertness and concentration|
|Insomnia medicines/“Sleeping Pills”||For people with infrequent insomnia, insomnia associated with depression, anxiety|
|Narcotic pain relievers||For people with only mild, infrequent pain|
Sometimes, drugs with multiple uses might have to wait for years before getting FDA approval for all its different uses. Off-label prescriptions allow doctors and patients to use these drugs and benefit from them. A classic example is the use of a class of drugs called as beta-blockers approved for use for treating high blood pressure. Researchers and doctors were convinced that this drug could be used against heart attacks and this was prescribed off-label for the same. Large-scale clinical trials and results have demonstrated the benefit off-label use of beta-blockers, proving that the doctors were right.
Similarly, statins, with FDA approval for reducing cholesterol levels and reducing heart attacks were given to people with diabetes to reduce risk of heart disease. This was off-label use of the drug since it is only recently that statins have been found to prevent heart attacks in people with diabetes.
Off-label drug use need not always give a positive result; there are many instances where in off-label drug use has proved to be dangerous. And in some cases it can lead to ethical issues surrounding access to treatment. For instance the controversy surrounding the use of Anti-retrivirals for treating CFS.
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