Adverse Events Interpretation

Imagine you have just been prescribed a drug that is new on the market. When you are given the medication you receive a handout of possible side effects.

Some of the symptoms read as follows: abdominal pain, constipation, dyspepsia, nausea, vomiting, fatigue, ear infection, decreased appetite, dizziness, headache, sedation, aggression, irritability, cough, influenza, rash.

Lengthy side effects lists concern many people. They begin to imagine a worst-case scenario and wonder if it is really worthwhile to take the medication based on all the things that could possibly go wrong.

Would you be surprised if I told you that the above list is the adverse events list for a sugar pill? Well, it is.

Today I'd like to talk about adverse events lists, how they are derived and the most effective way to interpret them when you are making a decision about a new treatment.

As you know, all new drugs go through a lengthy period of clinical research before they are approved for use in the marketplace.

Although adverse events can and do occur with most medications, the way they must legally be reported in product handouts can sometimes be misleading. During testing, anything adverse that occurs to a person while they participate in a clinical study must be documented as an adverse event regardless of whether or not it has anything to do with the study drug.

For example, if someone gets the flu while participating in a medication study, flu symptoms are recorded as an adverse event. If a person injures themselves while skiing, this is also recorded as an adverse event.

When studies go on for several months and involve many hundreds of volunteers, it is not surprising that there are a lot of recorded adverse events. But how do we sort through all of this information to determine which effects were likely the result of the medication?

This is why many new drugs are tested in comparison to a placebo (or inactive medication). While one group of volunteers receives active medication, another group receives a sugar pill. Neither group of subjects is aware of whether they are receiving the actual medication or the placebo.

Adverse events are recorded in the same way for both groups and the placebo's adverse events list will likely be just as long as the active drug's list. If the study takes place during flu season, it is probable that flu symptoms will show up to the same extent in the group taking the placebo medication.

When an adverse event is actually caused by the medication, it should show up above the background noise of other adverse events.

When it comes time for you to evaluate the likelihood of adverse events when taking a new medication, it is important to look at the differences between the adverse events reported for the placebo as well as the active medication. The difference between the two lists usually represents the most significant information.


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