What is an off label prescription?

Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication.[4] In the United States, the Food and Drug Administration Clinic for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication.[5] If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.

Off-label use of medications is very common. Up to one-fifth of all drugs are prescribed off-label ”

The FDA approves a drug for prescription use, and will continue to regulate the pharmaceutical industry through the work of the Division for Drug Marketing, Advertisement and Communication (DDMAC).[6] The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off label.

Off-label use of medications is very common. Up to one-fifth of all drugs are prescribed off label and amongst psychiatric drugs, off-label use rises to 31 %.[2] New drugs are often not tested for safety and efficacy specifically in children. Therefore, it is believed that 50-75% of all medications prescribed by pediatricians in the U.S. are for off-label indications.[3]

A study published in 2006 found that off-label use was the most common in cardiac medications and anticonvulsants. This study also found that 73% of off-label use had little or no scientific support [2]

Some drugs are used more frequently off label than for their original, FDA-approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off label, and more than half of cancer patients received at least one drug for an off-label indication. A 1997 survey of 200 cancer doctors by the American Enterprise Institute and the American Cancer Society found that 60% of them prescribed drugs off label.[3].

In the United States, FDA regulations permit physicians and other healthcare practitioners to prescribe approved medications for other than their approved indications. Marketing information for the drug will list one or more indications, that is, illnesses or medical conditions for which the drug has been shown to be both safe and effective. Pharmaceutical companies are not allowed to promote a drug for any other purpose without formal FDA approval.

However, once a drug has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both safe and effective, and are not limited to official, FDA-approved indications. This off-label prescribing is most commonly done with older, generic medications that have found new uses but have not had the formal (and often costly) applications and studies required by the FDA to formally approve the drug for these new indications. However, there is usually extensive medical literature to support the off-label use.

  1. David C. Radley; Stan N. Finkelstein; Randall S. Stafford (2006). "Off-label Prescribing Among Office-Based Physicians". Archives of Internal Medicine 166 (9): 1021::1026. doi:10.1001/archinte.166.9.1021
  2. http://www.npr.org
  3. "Why is off-label use of drugs so common in cancer treatment?".
    National Cancer Institute. Retrieved 2009-07-12
  4. http://content.nejm.org/cgi/content/full/358/14/1427
  5. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm
  6. http://www.fda.gov/AboutFDA/ClinicsOffices/CDER/ucm090142.htm

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Since 1975, the FDA has required labeling and advertising of HCG to state:

“HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or "normal" distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”

This does not mean its not safe, nor does it mean its not effective. What it means is that there are no double blind clinical studies that have been reported in peer reviewed clinical journals supporting the use of HCG as a dietary aid. You should talk to people who have done the diet and consult your physician.


Past side effects, although minor, were reported by patients taking HCG at 50-70 times the dosage prescribed for the HCG Diet (10,000 I.U.'s prescribed for increased ovulation vs 125-200 I.U.s prescribed for HCG Diet); we are not aware of any side effects reported from taking HCG for the diet. All past side effects from taking high dosage HCG were similar to symptoms that many women typically experience during pregnancy, such as delayed, shortened or prolonged menstual cycles or minor cramping.

These statements have NOT been reviewed by the FDA.

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