Those are easy warnings, they’re not going to discourage people from buying or doctors from prescribing or surgeons from using the product.

But consider this scenario…what if a product that, even by the sales reps admissions, required “babysitting” in order to get a surgeon to use, a product that is often used at the spur of the moment, without pre-surgical preparation to determine if it is appropriate for that patient…what if that product should have included a warning that, if the patient is allergic to an integral ingredient in it, very serious, even fatal reactions can occur. But, because the product is often used at the spur of the moment (precluding allergy testing to determine its appropriate use), and because the reps already have a very difficult time getting the surgeons to use it, and because this is a very expensive product that generates a major portion of income for the manufacturer, adverse events are underreported to the FDA, clinical trials are manipulated in order to assure positive outcomes and surgeons are not provided information for dealing with adverse reactions (that would admit a problem, and that is something that the manufacturer wants to keep secret)…Should that product’s manufacturer be left with no accountability?

If your answer is “no” to that question, then preemption is an immoral, perverse policy that should be overruled.

That “scenario” is a reality for my family and I’m certain that a semblance of that scenario is a reality for many others in America. Should we be left with no remedy? Should the drug and medical device companies be left with no accountability?

Sometimes it is hard to see the forest for the trees, but sometimes the trees are exactly what we need to see.

How many medications include in their labeling or packaging such helpful wisdom as “…..may cause constipation, may cause diarhea…”

Such information is no information at all. Of course, those notations are all driven by reported adverse effects. But there isn’t necessarily a cause and effect, and the timing of some unrelated malady becomes determinative in the eyes of the system.

How did this system morph into one that would today not approve aspirin if it had to go through the NDA gauntlet? The risk/reward is absurd - therapies that would make a meaningful improvement in the lives of many are prevented from use because of concern that a few might suffer….and that side effect profile generally is trivial compared to the root disease. The tyranny of the minority.

That’s exactly my point! The drug in question is Aleve — a drug you can buy at Walgreens. It’s not a dangerous drug. But the countless liability lawsuits against our industry has given us a “cover our butt” mentality that entices us to list every concievable side effect with the hope of lowering our liabilities in case we get sued. Do you know how many millions of people take Aleve every day to get rid of a headache or minor arthritis pain? How many of them complain of anaphylactoid reactions, angioneurotic edema, pancreatitis, vomiting, colitis, etc? None. Drug warnings are out of control and getting worse all the time. They are quickly becoming irrelevant.

I realize the good that they do, how important they are for our society and that most are reputable, but it doesn’t take too many bad apples to spoil the barrel. And when those bad apples can take your money and your health and then look you straight in the eye and tell you they aren’t accountable, I’m sorry, that’s the definition of vile.

Read the list of side effects (below) reported to be associated with Naproxen (Aleve) and then let’s talk about over-warning. Do you think these warnings accurately reporesent the dangers associated with this over-the-counter drug? Do you think anyone takes these warnings seriously?
—————

anaphylactoid reactions, angioneurotic edema, menstrual disorders,
605 pyrexia (chills and fever)
606 Cardiovascular: congestive heart failure, vasculitis
607 Gastrointestinal: gastrointestinal bleeding and/or perforation, hematemesis, jaundice,
608 pancreatitis, vomiting, colitis, abnormal liver function tests, nonpeptic gastrointestinal
609 ulceration, ulcerative stomatitis
610 Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia,
611 agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia
612 Metabolic and Nutritional: hyperglycemia, hypoglycemia
613 Nervous System: inability to concentrate, depression, dream abnormalities, insomnia,
614 malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction
EC-NAPROSYN® (naproxen delayed-release tablets), NAPROSYN® (naproxen tablets),
ANAPROX®/ANAPROX® DS (naproxen sodium tablets), NAPROSYN® (naproxen
suspension)
17
615 Respiratory: eosinophilic pneumonitis
616 Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema
617 multiforme, Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity
618 reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria)
619 or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of
620 pseudoporphyria occur, treatment should be discontinued and the patient monitored.
621 Special Senses: hearing impairment
622 Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis,
623 nephrotic syndrome, renal disease, renal failure, renal papillary necrosis

Source: http://www.fda.gov/cder/foi/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf

Your argument makes the case against preemption, it undercuts the over warning argument that the pro-preemption advocates have been espousing as being a cause for concer.

You are a simpleton!

I take all warnings seriously.

You are not and have never been sick. I hope you get diagnosed soon one day, you could use a dose of enlightenment.