A Question of Drug Safety: When to Pull Drugs off the Market?

The recent public outcry about heart damage caused by proper use of the oral diabetes medications Avandia and Actos has renewed the debate about how the federal Food and Drug Administration (FDA) determines which products are safe for public consumption.

There are increased risks associated with widely popular medications, including:

But the FDA pulls very few of these pharmaceutical products off of shelves. This is due to the lack of clear-cut procedures the FDA has for withdrawing a medication from the market. The administration, instead, provides "guidelines" for scientific experts to consider.

While some patient safety advocates and watchdog organizations criticize the FDA's policies, the FDA defends its decisions to not issue hard and fast rules when declaring medications unsafe. FDA spokesperson Dr. Joshua Sharfstein admits that the FDA could be proactive in setting new policies, however, he is still supportive of the current method of weighing each individual medication's risks and benefits before any decision is made.

How Does the FDA Determine if a Drug is Unsafe?

Drug safety experts like Dr. Brian Strom from the University of Pennsylvania (an FDA drug safety adviser) have given some insight into the process of the FDA analyzing whether a drug should be pulled off the market. Factors considered by FDA experts include:

  • The seriousness of the illness the drug is designed to treat - for example, more severe side effects (like loss of muscle tissue, liver damage or persistent diarrhea) may be acceptable for a cancer treatment, but not for a relatively minor condition like acne.
  • The risks involved - low-risk side effects like drowsiness or mild nausea may be outweighed by the possible benefits offered by the drug, while blood clots or an increased risk of heart attack probably are not.
  • The frequency at which severe side effects occur - if a medication is truly serving the greater good (i.e., successfully treating a condition afflicting millions of people), then the FDA may decide that it is an acceptable risk if only one person in a million suffers a seriously adverse reaction.

Regardless of whether the medication is still on the market or been withdrawn, if you have suffered serious injury as a result of the proper use of a prescription or over-the-counter drug, you may have a legal claim. You should consult an experienced prescription drug claims attorney in your area to learn more about your rights and options.

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