When Drugs Are Taken for the Long Term, the FDA May Fall Short in Ensuring Safety

Two recent actions by the Food and Drug Administration — both involving drugs found in some cases to cause the sorts of problems they are intended to prevent — highlight a key issue facing the agency.

That issue, according to a news analysis by The New York Times, is: How do you ensure the long-term safety of drugs for chronic diseases that patients might have to take for the rest of their lives?

The crux of the problem, the Times pointed out, is that the unexpected can occur after patients take a drug for decades, but drug trials carried out in this country generally last only a few years at most.

“Here is a wide-scale institutional failure,” said Daniel Carpenter, a Harvard government professor and expert on the FDA. He said the FDA has placed “far more resources and requirements” in evaluating drugs before they enter the marketplace than it does in monitoring what happens to patients after years of taking the medicines.

Still, while many experts would like to devote more resources to studying the long-term effects of drugs, they also point to obstacles. For example, it can be difficult to persuade doctors — once a drug already is approved and in wide use — to assign their patients randomly to one approved treatment or another to conduct a study that could go on for many years. One possible solution, however, might be the development of a national database that would track drug use and complications.

One of the drugs that recently underscored potential long-term dangers is Avandia. It was widely prescribed to treat diabetes, a disease that can lead to heart problems, but the FDA recently put tight restrictions on its use — and European regulators banned it completely — because it was found to raise the risk of heart attacks.

Another example of the issue is illustrated by bisphosphonates, which are sold under such names as Fosamax, Actonel and Boniva. They are commonly used to prevent fractures common to people suffering from osteoporosis, but now will need to carry labels warning that the drugs can lead to rare fractures of the thigh bone and a rare degeneration of the jaw bone. Still, bone experts say the benefits outweigh the risks, and use of the drugs was not restricted.

Related Post:

FDA Slaps Tight Restrictions on Diabetes Drug Avandia

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