Off-label drug use is the act of using or administering a medication in a way that is different from for which it was approved by the United States Food and Drug Administration, and opposite as how it was described in the FDA-approved drug label.
The use of FDA-approved drugs off their labels albeit not regulated by the consumer protection agency, is legal in the US and in some other countries. While it may be beneficial in some areas, the use of drugs outside their approved indications may bring about unnecessary health problems. Fosamax, for instance, has been reported to cause adverse effects such as low-impact fractures, and deterioration of the jaw. Using the osteoporosis drug off and within its label may expose a person to these inadvertent effects.
Off-label drug use has been reportedly common in cancer treatment, medical experts say. The findings from a recently conducted study which zeroed in on the off-label use of bisphosphonates could be an addition to existing treatments for complications arising from certain cancers.