A black box warning is the FDA's strictest warning for a prescription medication. It is on the label or package insert of a drug which may have a high risk of a fatal side effect, like a heart attack or a non fatal but disabling side effect like bone loss or tendon ruptures.
Sometimes a black box warning is recommended by a panel but not adopted by the FDA.
Many drugs have black box warnings, here is a link to a list.
http://www.formularyproductions.com/master/showpage.php?dir=blackbox&whichpage=9
The warning is meant especially to alert physicians so that the medication will only be prescribed in exceptional circumstances and or to people who are not susceptible to the specific risk. Generally speaking, it is not believed that the warnings are effective.You might wonder why a drug that has a risk of a serious side effect is available to you at all and so do I, but there are justifiable reasons.
At times the serious side effect only applies to a certain group of people. For instance, and if memory serves me correctly, Vioxx had a very strong warning, if not a black box warning, about heart attack in people who had high blood pressure. If you did not have high blood pressure than Vioxx did not expose YOU to that risk. Except, they were wrong, it exposed everyone to increased risk for heart attack and that is why the drug was pulled off the market.
Even if Black Box warnings are meant for physicians you must be an informed consumer. You MUST be an informed consumer. Doctors are people too and they make mistakes and they fall prey to pharmaceutical persuasion and sometimes they don't know the latest info on a drug. Better you ask the pharmacist. Better still that you read the medication guide. Actually, I suggest you read the medication guide before you even fill the prescription. Medication guides can be found here: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm
So when would you choose to take a drug with this warning? I am going to suggest that you do so as a last resort or if you are not in the target group for the adverse event risk. I personally, ALWAYS chose medications as a last resort. One of the reasons I offer for that is post marketing drug analysis. Many times, the minor side effects found in a drug study, or major effects found in a few people, significantly increase when the drug is made available to the general population. There are many instances of where drugs are pulled some seven to ten years after they were introduced, because the risks did end up to be too high. http://www.bmj.com/cgi/content/full/318/7188/944/a
http://www.bmj.com/cgi/content/abstract/294/6568/355
Questions to consider? Is this the ONLY treatment for my problem? Maybe it is cheapest or quickest, but that doesn't mean safest. Maybe a safer drug will have a 80 percent cure rate and the drug with the risk of heart attack has a 90% cure rate, but that ten percent extra chance of improvement won't matter if you are dead.
I can say that when I had those horrible migraines a few months ago, I felt, truly, that the risk of any side effect was worth the chance that the headache would go away. I recall lying in bed and thinking, "this drug may kill me" and then thinking, "I don't care." That was a very very bad week of head aches as I am NOT looking forward to death. So I think that is one of the times you take a risk.
Not in all situations, but certainly many, I agree with the following statement:
"The point to all of this is simple. Make the black-box warnings irrelevant by changing your lifestyle so you won't ever have symptoms that drugs would be needed for."
Joseph Mercola, D.O.
Of course, Dr. Mercola seems a man after my own heart, except that I realize that there is a time and a place for medication and when that is the best option it SHOULD be utilized.
Be Well.
No comments:
Post a Comment