Medications and Lawsuits - Is everything what it seems?

Stephanie Health Guide
  • I try to keep up on what's new and upcoming in the "World of Reflux." One of the ways I do this is that I get automatic alerts to my inbox when things come up on the web dealing with reflux. Much of what I get is not terribly useful. Sometimes I come across something interesting. Lately I have been getting an awful lot of links that take me to legal sites. The one today- well it just makes me mad. I'm just tired of all of the lawsuit talk and all of the rants about how the drug manufacturers are out to get us.


    Recently I read up and wrote about how a new drug gets to market. I have to admit that I was somewhat surprised to think about the post-marketing research that goes on. In other words, there is absolutely no way a manufacturer can test every situation out there so after the drug goes on the market the manufacturer and the FDA monitor issues with medications. This is how drug interactions and long term effects are discovered. When small issues are discovered press releases go out and the medication gets a warning added to it. When it's more serious the medication may get a "Black Box Warning" which is the highest warning a medication can get without being pulled from the market. Reglan currently has a black box warning due to the potential for nervous system side effects known as Tardive Dyskinesia.

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    Getting back to the article I read today on a lawyer site. This one has a woman complaining about the polyps in her stomach that she states are due to the Proton Pump Inhibitor (PPI) she takes. She says she doesn't blame the docs but does blame the manufacturer. She goes on to say that despite the polyps she continues to take a PPI because it's the only thing helping her reflux. So, let's see she's mad that the manufacturer made a drug that gave her polyps but she's still taking it because it helps your reflux. Kind of sounds like she had to take everything into account and look at the big picture??? Why exactly is she mad at the drug manufacturer? Does she want the drug removed from the market? Does she think the drug manufacturer withheld that she might get polyps? If she knew there was a chance of polyps would she still have taken it for 5 years?


    Hmmm, that 5 year thing begs for addressing too. I'm probably one of few people who reads the big detailed print outs on medications. Nowhere in those print outs does it say it's okay to take it for 5 years. In fact, most of them say they can be taken for up to 8 weeks. Eight weeks is far from 5 years. Why then do so many people take them so long? Well, that's where the post-marketing stuff comes into account. You take a med for 8 weeks, it works, you go off of it and your symptoms go off so you go back on it and before you know it you're on it for good. Well, when a lot of people do the same thing it becomes an off-label usage. Studies are then completed to see if there are long term effects. When a long term effect does become known it is then reported and restudied. Each and every patient needs to then discuss the long term issues with their physician and come up with a plan that is good for their situation. As I've discussed before for my Mom continuing on PPIs and risking osteoporosis was a better option than bleeding out from an ulcer. On the other hand, being not as well controlled but okay on H2 blockers was a better option for my daughter and me given our age and how long we will likely be on meds. In fact, for my daughter and me surgery might be something we consider in the future.


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    So, in summary, I have to say I'm not pro-manufacturer nor am I anti-lawyer. There are some very valid lawsuits against manufacturers who at some point intentionally hid things that were bad in their studies. This is bad and the manufacturers should in fact pay for them. As a society though we need to think about the big picture and realize that with everything we put into our bodies (medications, foods, vitamins, exercise, etc.) there are both positives and negatives that need to be taken into account. I know I am glad there are so many reflux meds. My grandfather died in his 40s due to his stomach issues. My Mom got 5 units of blood when I was 14 in order to keep her from dying from her ulcer they couldn't get to stop bleeding. My daughter's reflux was so bad as a baby that she was hoarse, refusing to eat and losing weight. So, yes, there are side effects that aren't good but I have to remember the good that they do as well. And, I don't think drug manufacturers are out to just make money by killing us with their drugs.......


Published On: December 13, 2010