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Holes in U.S. Drug Safety Net

Consumer Reports: Drug Approval, Follow-Up 'Flawed'

Institute of Medicine to the Rescue

Lipman, Gardner, and Trewhitt all praise one thing about the FDA. The agency already has asked for help. Last year, it turned to the independent Institute of Medicine (IOM) for advice. An IOM committee has since been holding hearings. Its recommendations are expected in July 2006.

"The FDA has asked the IOM to thoroughly investigate the drug safety system," Trewhitt says. "It would behoove us to wait to see the results."

Lipman says it's already time for Congress to act.

"We are getting to where this is a problem for our government," he says. "There have to be some bills written that would address some of these problems and that would create a better workforce for the FDA, and that would give them more monetary resources so they don't have to rely on pharmaceutical company fees to process new drugs. Basically the buck passes back to our Congress."

Gardner says the problem goes far beyond the FDA. The real issue, he says, is health care in America.

"Our health care system is in real trouble," Gardner says. "This is an example of a real problem where we don't have the politics yet to create a solution."

Drug List From Consumer Reports

The Consumer Reports article lists drugs as examples of safety-system failures.

"These drugs are just examples," Lipman says. "There are bound to be others. Even a perfect safety system could never detect every problem of every drug."

The drugs include:

  • Celebrex
  • Estrogen, either alone (Premarin and others) or with progestin (Prempro and others)
  • Accutane
  • Ovide
  • Depo-Provera
  • Lariam
  • Crestor
  • Serevent
  • Meridia
  • SSRI antidepressants and other antidepressants
  • Topical immunosuppressants such as Elidel and Protopic

Do not stop taking these drugs if you're using them, Consumer Reports warns. The drugs are helpful for people for whom the benefits outweigh the risks.

"These are important drugs. They are very useful drugs," Lipman says. "But in many cases they are not the only drug for the condition. And the patient should know that by taking one of these drugs there is a certain inherent risk, and the patient should be aware of this risk."

Lipman advises patients using these drugs to talk with their doctors about whether there is another drug that can be used with less risk. And all patients taking any drug should be aware of possible side effects and should tell their doctors about any ill effects -- even those not listed on the label.


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