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| Side Effects |
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DrugStudy writes, "All medicines have "side effects." How do you figure out if the benefit is worth the risk?"
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DSI Newsletters, Issue 5:
Side Effects
A "side effect" of a medication or a drug is any bad thing that occurs after you consume a drug that is actually caused by that drug.
An "adverse event" in an experimental drug study is anything bad that occurs while you are in the drug study, whether or not there is a cause and effect relationship. If a relationship can be proved, then the adverse event becomes a side effect.
An example of an adverse event that wasn't actually a side effect was in the mevacor drug trials. It happened that more people in the mevacor group had car accidents than in the placebo group. So, in 1987, when mevacor came out, the product insert said to be careful of your driving while consuming this drug because some people in the drug trial had car accidents while taking this drug. There was no proposed mechanism how mevacor could have possibly caused this. Many people were alarmed enough that they'd rather die of a heart attack than risk a car accident. Meanwhile, the doctors told the patients to take the mevacor and ignore the data that didn't make sense. Later on, more drug studies refuted this idea and this was removed from the product insert.
An example of a side effect is hepatitis with mevacor. This drug is metabolized through the liver; that is, the liver changes it into something else. Sometimes, about 2% of the cases, the doctor notes a blood test abnormality where a type of blood test called the liver enzymes goes up. The patient doesn't feel anything wrong. This is not dangerous. The doctor then stops the drug and this side effect goes away. There is a clear-cut cause and effect. We understand the mechanism of action how this side effect occurs. We know how to treat it so that nothing goes wrong with the patient.
When you read a product insert, you need to think about these differences. If you are reading a very long list of symptoms, often that are the opposite of one another like diarrhea and constipation, and the heading says something like the following adverse events were reported in research subject volunteers consuming the drug, chances are that all of those symptoms are not related to the drug. The symptoms that are actually side effects will be listed in a special way. It will say what percentage of people compared to another group had this particular symptom and it will list the mechanism of action.
The purpose of the FDA to list all these adverse events is to encourage patients to ask questions of their health care providers about their treatment, not to scare them away from taking the drug. Unfortunately there are many patients who die of heart attacks and strokes each day needlessly with perfectly fine livers fearful that the 2% chance mevacor has of hurting their liver is too great a risk to take. We need a list somewhere for what the risk of not taking the drug is. For example, if you are a smoking male over 45 years old with diabetes and high cholesterol, your risk of heart attack is over 30%. Clearly, the 2% risk of hepatitis is worth the chance of not dying from a heart attack.
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Posted on Jul 30, 2005 17:23pm.
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