Are there dangers associated with using drugs off-label?
Most drugs that are prescribed off-label haven’t been tested for such use in large populations using double-blind, placebo-controlled studies. These studies, which are the “gold standard,” can take years to complete, but they are the only way to prove that a drug is both effective and safe. Some drugs that haven’t been exhaustively tested for off-label uses will invariably prove to be ineffective. Others may prove to be dangerous. For example, in 1973 the FDA approved an appetite suppressant, fenfluramine, for short-term use. Doctors then began prescribing it for longer periods (an off-label use) in combination with a drug called phentermine. Approximately 100 cases of heart-valve disease were reported in patients taking the combination drug, commonly known as Fen-Phen, before it was removed from the market. What role do the drug companies play? It’s illegal for pharmaceutical companies to promote — through advertising, conversations with doctors or other means — off-label drug uses.
