Why do they make us sick if they’re supposed to be making us better?

Did you know that adverse drug reactions are one of the leading causes of death in the US?

Pharmocovigilance is the study of drug-related injuries used to make warning and withdrawal recommendations. In order to determine if there is a relationship between a medication and adverse reactions, the FDA looks at 5 things: 1) time relationships between usage of the drug and the reaction, 2) pathophysiology of the reaction, 3) any competing causes, 4) response to removal of the medication (dechallenge), and 5) response to reintroduction of the medication (rechallenge). If the FDA finds a relationship between the drug and the adverse reaction, they can then determine if the medication caused the adverse reaction. A medication can be considered the cause of the adverse reaction if, had the patient not taken the medication, 1) the reaction would not have happened, 2) the reaction would have happened later, or 3) the reaction would have been less severe. This information comes from the adverse drug event reports submitted by doctors, nurses, physician assistants, patients, and drug manufacturers.

In order for a drug to be termed as “safe” its usage benefits must outweigh the risks in the population the drug is intended to treat and for its intended usage. Over 75 medications have been withdrawn from the market due to safety questions in the last 10 years!

Drugs are pulled from the market based on the nature and frequency of adverse reactions and how the medication in question compares with other treatments out there. Most removals occur because the adverse reaction was not seen prior to wide distribution. Some adverse reactions are so rare that they can’t be seen or predicted before the medication is marketed. Other times there are hints that can be seen in retrospect, but they weren’t serious enough to necessitate the drug’s removal. Adverse reactions that occur 1 in 10,000 or 1 in 5,000 patients won’t be seen in clinical trials. Clinical trials are designed to look for “common” reactions that occur in 1 in 1,000 patients.

I bet you’re a little curious about those reactions. Well don’t worry…I’ve got two charts filled with big words to confuse you!

Drugs can be pulled off the market for a variety of reasons. The drug could be more toxic than expected, safer alternatives could become available, it could have too many dangerous drug interactions, or people could just be flat-out using it wrong. Very rarely is the decision made overnight though. Many times the manufacturer will try educating prescribers about safe usage or labeling changes. The drug can also be labeled as “second-line” or has it’s status restricted.

Watch this educational video, part of a series called The High Cost of Medication. This portion is about manipulation of clinical research and the role of the drug companies influencing the FDA.