FDA-approved drugs don’t tell the whole story

You may be among the many patients who felt relief to learn that medication could control your medical condition instead of resorting to more drastic measures such as surgery. When your doctor prescribed a relatively new drug, you probably felt no concerns because you knew the drug had received the approval of the Food and Drug Administration.

However, when the medication’s side effects began to worsen and you ended up in the hospital, you likely wondered how such a dangerous drug could have received a thumbs-up from the federal government.

How reliable is FDA approval?

The fact is that almost one third of all new drugs approved by the FDA are implicated in some kind of medical emergency once they hit the market. In fact, it is possible that some of the warnings on your medication’s label resulted from negative side effects that occurred while others used the drug.

Recent data compiled by the American Medical Association reported these findings:

  • Between 2001 and 2010, 222 new drugs received approval from the FDA.
  • After these medications reached the market, 123 patients reported ill effects after taking them.
  • Those reports resulted in the FDA reviewing and acting on the claims against 71 drugs.
  • For most of those flagged medications, the FDA required box warnings or other communications to alert you of potential dangers.
  • The FDA directed manufacturers to remove three of the drugs from the market.

Authors of the study believe these statistics demonstrate the success of the country’s process for testing and marketing pharmaceuticals. While most drugs undergo limited testing before becoming public — sometimes fewer than 1,000 patients participate in trials — the FDA monitors the drugs once they hit the market, tweaking the warnings and approved uses.

However, this may not feel very reassuring to you, especially if you suffered a life-changing event following the use of an FDA-approved medication. Being part of the learning curve is not likely what you expected when you filled your prescription.

Taking action

Drug safety experts assure you that the process the FDA uses to approve and monitor new drugs is the most efficient way to see how certain drugs work in a larger population. Medications behave differently in different types of people, so your gender, race, age, size and medical history may affect the way a drug works — or doesn’t work — in your body.

Nevertheless, you may feel that the FDA or the drug manufacturer knew that the drug you took presented risks that were much greater than the warnings indicated. In similar circumstances, victims of bad drugs have sought justice through civil lawsuits or even consumer class actions. A Hawaii attorney can best advise you of your options.