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When a doctor fills in a prescription for a patient, he or she may always believe that the prescribed medication has been approved for that indication, online media reports.  While it is a fair and reasonable belief, the notion may not always be true.  An emerging study shows that in about five written prescriptions of commonly used medications in the United States, at least one has been dispensed for a specific indication that does not bear a formal approval from the consumer protection agency.  Off-label drug use, as this medical practice is known, has been especially common in cancer treatment.  A previously conducted study, which showed how bisphosphonates might ease pain for those with bone metastasized prostate cancer, could be an example of off-label drug use through bisphosphonates.

Off-label drug use happens when a person’s health care provider prescribes a medication for an indication that has not been approved by the US Food and Drug Administration, according to medical experts.  It is the act of using or administering a drug in a way that has not been specified in the FDA-approved packaging insert or product label.  All FDA-approved medications distributed in the US carry an individual drug label comprising of a written report with specific details and instructions about the drug including its basic information, approved doses, and how it should be administered for a certain medical condition.

The off-label use of a drug while is not being regulated by the FDA, is not illegal in the US and in some other countries, medical experts say.  Patients who may have rare diseases or cancer may find the most benefit out of the medical practice, according to cancer specialists.

While it may be beneficial in some areas, the use of drugs outside their approved indications may bring about unnecessary ill effects.  For instance, the off-label use of Fosamax as treatment for hypercalcemia (excessive blood calcium levels), and cancer that has spread or metastasized to the bones, may also expose a cancer patient to the bisphosphonate drug’s inadvertent effects.  The Fosamax Lawsuit Help Center bears current and comprehensive information involving the side effects and legal claims related to the blockbuster osteoporosis drug.

URL References:

webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know

cancer.org/Treatment/TreatmentsandSideEffects/TreatmentTypes/Chemotherapy/off-label-drug-use

osteoporosis.emedtv.com/fosamax/fosamax-uses-p3.html

mayoclinic.org/news2012-rst/7015.html

medicaldaily.com/news/20120806/11316/off-label-drug-use-prescription.htm

consumerreports.org/health/resources/pdf/best-buy-drugs/money-saving-guides/english/Off-Label-FINAL.pdf

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