- Prescription Drugs and Side Effects -
The Process For Determining Clinical Trial Data for Stop Smoking Medications

All prescription drugs have side effects. This is the one true caveat of interpreting clinical trial data.

Double blind pharmaceutical clinical trials are conducted to determine side effects of prescription drugs as well as their efficacy.

These studies may not report every adverse drug reaction that can occur with the drug being studied. Once the drug is on the market, adverse drug effects, drug interactions, and other data are collected in post marketing surveillance. It can take a long time for many adverse drug reactions to make their way into the spotlight.

Pharmaceutical Clinical Trial Data

The Efficacy and Side Effects of Prescription Drugs

In most countries, before a drug is allowed to be put on the market it must be proven to be safe. Drug companies also have to prove that it will actually do what they want it to do.

As long as the probability of getting the desired effect is larger than the probability of getting undesired effects (or side effects, the drug will probably proceed to market.

Double blind clinical trials are conducted to prevent the placebo effect. If neither the researchers nor the participants know who is taking the real drug or the sugar pill, then the research is considered to be valid.

At the end of the study the results are "unblinded" and then the results of the two groups are compared.

Pharmaceutical clinical trials carefully control the participants allowed into a study in order to prevent the results being confounded by other variables like age or other illnesses. They generally set quite strict criteria for inclusion in a clinical trial.

Once a drug goes to market it is prescribed for all kinds of people and under all kinds of conditions that have never been studied.

Prescription Drugs and Side Effects - The Serious Ones

The term "side effects" is a misnomer as technically there are only effects of drugs.

The term "side effects" is simply a euphemistic way of labelling an effect from a drug that isn't wanted.

What is an Adverse Drug Reaction?

Technically an adverse drug reaction is a serious side effect that harmed a person taking the drug under the correct conditions and at the correct dose.

In reality an adverse drug reaction is an unpredictable side effect that occurs because of variations in how the drug is administered by the user, how it is prescribed by the health care provider, and how it interacts with a person's own body chemistry and other substances that are in the body.

Once a drug is on the market it is difficult for consumers and professionals alike to predict everything that can happen with prescription drugs, their side effects or even adverse drug events.

Pharmaceutical clinical trial data is obtained under carefully controlled conditions. Once a drug is on the market these conditions cannot be controlled and many adverse drug events do not occur during clinical trials.

Instead they show up afterwards when the drug is being used by a larger number of people in a wider variation of conditions.

So before you take any pills to stop smoking, make sure you fully understand the risks and the possible benefits of taking the drug as well as not taking it.

(Think about it...what are the risks of NOT taking pills to stop smoking?)

So What Does This have to Do With You
and Stop Smoking Medications?

When you read clinical trial data for stop smoking medications the numbers and terminology can be confusing.

By all means read everything you can and discuss it with your doctor.

But here is what you need to know about stop smoking prescription drugs, their side effects and possible efficacy in helping you to quit cigarette smoking.

• There has never been a pharmaceutical clinical trial to determine how you will react to this drug.


• Don't defer to your doctor but rather listen and evaluate any information that is provided. Different doctors have different experiences with stop smoking drugs and will likely base their prescription decision based on their past experience.


• Discuss your pending decision with a pharmacist. They are the true experts in pharmacology not your physician.


• Investigate all methods to quit smoking not just the pharmaceutical ones. Quitting smoking facts show that cognitive and emotional support improve your chances of success when you are trying to quit cigarette smoking. (See Help to Stop Smoking)


• Recognize that many people quit cigarette smoking successfully without ever taking stop smoking pills of any kind. These are the people in the pharmaceutical clinical trials who took the placebo.

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