| Indications for a drug are diseases for the treatment | | | | particularly with regard to the indication for which it is |
| of which it can be used effectively. There are two | | | | being approved, dosage, storage, and route of |
| types of indications: | | | | administration.However, there is no binding on doctors |
| | | | to prescribe a particular drug only for its |
| 1. Labeled indications: These are indications approved | | | | FDA-approved indication. It is entirely legal for doctors |
| for treatment by a specific drug. In the United | | | | to prescribe drugs for diseases for which they (the |
| States, the authority granting the approval is the | | | | drug) are not approved. The doctor's judgment |
| Food and Drug Administration (FDA). Labeled | | | | comes into play here, and law respects it. |
| indications are mentioned, along with information on | | | | Manufacturers however are not allowed to market |
| dosage, etc. on the drug's label. | | | | their drugs for off-label indications, howsoever |
| 2. Off-label indications: These are indications that the | | | | effective they may be in the treatment of those |
| FDA has not approved for treatment by a specific | | | | indications. (Note: The only exceptions are certain |
| drug and are not mentioned on the drug's label. An | | | | 'controlled substances' such as opiates, which must |
| apparent anomaly: Some drugs are used more often | | | | be used only for approved purposes).Why |
| for off-label indications that labeled indications. For | | | | manufacturers don't seek approval for |
| example, a research by the US General Accounting | | | | multi-indications: FDA approval costs money. |
| Office in 1991 showed that a third of all drugs used | | | | Manufacturers have to invest in trials to satisfy the |
| for treatment of cancer are off-label. Though this is | | | | FDA on an indication-by-indication basis. Thus, more |
| old research data, the overall picture has not | | | | indications they seek to obtain approval for, the |
| changed. A more recent example would be that of, | | | | more the manufacturers have to spend money. |
| say, Lexapro, the anti-depressant introduced in the | | | | Manufacturers don't consider this extra expenditure |
| market in 2002. Lexapro's labeled indication is unipolar | | | | and effort as commercially justifiable because of one |
| depression, but doctors often prescribe it for bipolar | | | | or more of the following reasons: |
| depression to, and with good results. Another | | | | - There are already drugs in the market that are |
| example is the tricyclic anti-depressant group, whose | | | | established for the treatment of those additional |
| approved indication is depression, but is used more | | | | indications. |
| for treatment of neuropathic pain.The fact that so | | | | - The market for those indications is small. |
| many drugs are widely prescribed for off-label | | | | - The manufacturer wants to have a specific |
| indications surely suggests that such uses are not | | | | positioning for the new drug. So, is off-label safe?: As |
| only not dangerous, but may also be more effective | | | | can be understood from the above, the answer is a |
| than approved drugs. How does one explain this | | | | resounding 'yes'. The difference between labeled and |
| apparent anomaly?The FDA approval process: To | | | | off-label indications is important for the manufacturer, |
| understand the above question, it is necessary to | | | | but not the patient or the doctor who are only |
| understand the FDA approval process. The FDA | | | | concerned with the effect. Therefore, if your doctor |
| requires manufacturers of new drugs to conduct | | | | prescribes you a medicine on whose label (or insert) |
| many clinical trials to demonstrate the safety and | | | | your specific ailment is not named, don't think that |
| efficacy of the new product. If satisfied, the FDA | | | | the doctor has erred. He or she is just following a |
| and the manufacturer decide on the wording to | | | | widespread and trusted practice. |
| appear on the drug's label and package insert, | | | | |