More than one in five of the prescriptions U.S. doctors write for 160 common drugs is for a use other than that approved by the Food and Drug Administration. The practice is perfectly legal, though patients are largely in the dark about what "indications" or uses the FDA has approved for different prescription medications.
These "off-label uses" have not been scrutinized by the FDA for safety and effectiveness. It's not legal for drug companies actively to promote a drug for "off-label" purposes. But the practice means big money for drug makers, and some do it anywa.
(just last month, Pfizer agreed to plead guilty to promoting off-label uses for some of its medications and was fined $2.3 billion by the Justice Department, according to the Justice Department website).
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In a commentary in the latest issue of Archives of Internal Medicine, three writers from the National Institutes of Health make it pretty simple:
- do a little research before writing off-label;
- think twice before offering something that's new to the market, carries risks of dangerous side effects or is very expensive;
- in most cases, acknowledge uncertainties to the patient;
- and share what you've learned with other doctors, especially if the patient did poorly on the medication.
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