If the FDA determines that a drug is “safe”, it is released to the public. When most of us hear the word safe, we think of “not dangerous” or “unlikely to cause or result in harm, injury, or damage.” We assume that any drug that the FDA considers “safe” will not be harmful. This is part of the reason that so many people take prescription drugs that were not prescribed for them but they took from a medicine cabinet or purchased on the street.  They believe that any drug sold in a drug store is “safe”. Many people, despite the long list of side effects that they hear in the television ads, believe that if a drug was approved by the FDA and prescribed by their doctor then the drug is “safe”.

According to Janet Woodcock, M.D., director of the CDER, “safe” has a different meaning to the FDA:

“When it comes to any drug,‘safe’ means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use. Safe does not mean harmless.”

So safe does not mean harmless or that the drug will not adversely affect many people.  It just means that the FDA has determined that the benefits of the drug outweigh the risks shown in the clinical trials and the drug can go to the public for its real test. The FDA says,

“So, the safety profile for new drugs that come on the market is never totally defined because new drugs are studied only in relatively small and homogeneous (similar) patient populations. The complete safety profile of a new drug will be defined only after it has been approved and is in use on the market.”

Does this approval process make sense? If a cancer drug causes harm to some cancer patients but may help others, if the risk is known, it is proper that a cancer patient might choose to take the drug in spite of the risk. We also know that if testing were forced to be continued for many years on larger and larger groups of people for all drugs, many drugs that might have saved lives would be delayed unnecessarily. However, at a minimum, doctors and patients need to understand the risks of any drugs before they are prescribed or taken by the patient.