Class Action Lawsuit consideration regarding inhaled steroids and low tension glaucoma

This is a discussion of considerations for some type of lawsuit, perhaps a class action lawsuit with regard to the manufacturer or manufacturers of certain inhaled steroid products primarily used for the control of allergic reactions.

This is, for me, a newly discovered drug interaction (Aug. 2004) with my ongoing low tension glaucoma.  I have just recently learned, while reading a brochure about glaucoma, that I should be avoiding all steroids, most certainly inhaled steroids.  I learned of this while waiting for my appointment at Wills Eye Hospital for a consultation regarding trabeculectomy surgery.  I was truly surprised that I did not know about this possible risk of inhaled steroids.  One reason is, I usually take the time to read all the fine print on the "indications" sheets delivered with a given medication.

I have allergies, primarily I'm allergic to grass, you know the kind that grows in your lawn.  During the spring when lawn mowing season begins I start to have pretty significant reactions.  Teary eyes, runny nose, sometimes incessant sneezing, and at times throat congestion to the point I must stop what I'm doing.  In the mid 1990's it was bothering me enough that I went to the doctor.  A nasally inhaled steroid was prescribed, "triamcinolone acetonide".  I'm going to avoid Trademarks, sorry.

No concern about glaucoma and no indications provided by the manufacturer.

At this time I had no real concerns about glaucoma.  After I used this steroid nasal inhaler for a couple of weeks I did find it significantly reduced my allergy symptoms.  In fact if I remember correctly ( mid 1990's ) the "indications" at this time implied that in some cases due to systemic effects of the medication, itchy eyes may even be reduced, and in fact in the long term this is one benefit I appreciated the most!  The product does do what it is supposed to do.

Here are links to the manufacturer and the "Indications" or information for the patient:
Manufacturer of triamcinolone acetonide
Please note the manufacturers name has changed since I started taking this product.
Current "Indications":

Please notice in the current "Indications":
"Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including triamcinolone acetonide."

I have a copy of the indications for this medication from Jan. 2001.  These indications have a revision date of 11/96, pretty old.  There is no mention whatsoever of raised intraocular pressures or glaucoma itself!  

I've been taking this medication since the mid 1990's and it may well have caused my low tension glaucoma!  Why is there no mention of these negative side effects?  This seems like a legitimate basis for a lawsuit, perhaps a class action lawsuit.

Why?  Read on!

The systemic effects of steroids and their impact upon individuals has been known since the 1960's!

Here is an article from the folks at Wills Eye Hospital.
http://www.wills-glaucoma.org/supportgroup/20021113.php

This article indicates these negative systemic effects have been known since:
"Dr. Rick Wilson:  I think it was back in the Sixties (Bernie Becker at Washington University in St. Louis, Missouri.)"

The 1960's

Other bad news for me:
"Dr. Rick Wilson:  While only 5% five percent of the general population is steroid responders, 95% of primary open-angle glaucoma patients are classified as steroid responders.  If steroid use is prolonged, 50% or more of the population is steroid responders.  Children may be especially susceptible.  There's an increased incidence of steroid responders in relatives with glaucoma, and persons with diabetes and high myopia".

I have high myopia as well, not looking good.

"Dr. Rick Wilson:  The rise in IOP takes, on average, three weeks to months.  The decrease in IOP is also slow, taking weeks to resolve."

My appointments with my ophthalmologist in the past were typically on a 6 month period unless he saw something even more out of the ordinary.  I only take these steroids for about 2 to 3 months in the Spring and rarely in the fall.  It could be the elevated pressure that occurred due to the steroids was never detected by my doctor simply because of timing of the appointments.  All the doctor saw was damage due to glaucoma ( past elevated Intraocular Pressure ).  At times my doctor would see small pressure elevations, this of course resulted in more medications which reduced the pressure to some extent perhaps counteracting the negative affects of the inhaled steroids.  I really can't blame my doctors, there is no indication on the medication I was taking that there was any problem, but clearly this is a well known negative interaction.

As far as I know at all times my doctors did have lists of medications I was taking.  But I was only taking the inhaled steroids in the Spring and Summer so the topic may never have come up.

Why weren't these negative findings on the "Indications" that come in the box for these inhaled corticosteroids?

Some discussions talk about topically applied steroids versus inhaled or even eye drops.  But my reading indicates that inhaled steroids are probably worse than topical steroids.  When you shoot something up your nose, or put drops in your eyes, it's almost as good as putting an IV needle in your arm!  So I don't think this could be the reason.  Perhaps the words "may cause glaucoma" would reduce sales.

Of course I've now discontinued any and all of these steroids.

Again I must say the products do work, but the price is the loss of my vision!  I'm not looking forward to next Spring at all, the itchy eyes can be awful.  This season when I mowed the lawn I wore a mask.  This helps a lot.  But the worst part of the season is over and I was taking the steroids during the worst part.  Oh well some fun to look forward to next year.

I've also used another product

Fluticasone propionate inhalation aerosol.  In addition to the grass allergy, I've been starting to have lung and throat congestion when I do heavy labor outdoors, so a fluticasone propionate inhaler was prescribed, again seasonally, to prevent the throat and lung irritation form occurring in the first place.  This medication works well, also.  But it's an inhaled steroid, you shoot this through your mouth to treat your throat and lungs.  This medications "Indications" or "Important information for the customer" makes no mention whatsoever regarding glaucoma, or increased intraocular pressure.  In fact I find this very wordy blurb uninformative, perhaps intentionally so.  Here is a link to the complete prescribing information ( pdf ):
fluticasone propionate prescribing information

The customer no longer receives the "complete information" and in fact doesn't receive critical information regarding safety of the products use.  It appears the pharmaceutical industry is trying to pass all responsibility for properly informing the customer of the safe use of their product onto the doctor and pharmacist.  This is upsetting, just put the information in the box like it's been done for years!  This approach is probably being used to reduce liability and therefore exposure to lawsuits and class action lawsuits.

Here's that quote again; of course it's not even in the box for the customer just on the website ???

Oral inhaler:

"Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including fluticasone propionate."

Nasal spray:

"Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including fluticasone propionate."

So even if the pharmacist or doctor has a sample of the medication the dangers are not indicated on, or in, the box.  One must reference another information database to find out you should not be using steroids if you have glaucoma.

This seems unethical to me, I'm the patient and customer of these manufacturers, they should be informing me of the risks involved directly.

I can't find a copy online of the "blurb" that comes in the boxes, very annoying.

I hope I've clarified why I feel justified in considering a lawsuit or class action suit specifically targeted at the manufacturers of these products.

Of course the retort will be, prove these inhaled steroids actually caused your low tension glaucoma.  But then perhaps the manufacturers have already statistically proven the possibility.  So all that remains is for me to fall into the class requirements.

So please remember you should not use steroids if you have elevated intraocular pressure, glaucoma, or low tension glaucoma ( actually now normal tension glaucoma ?).  At least consult with your doctor  If anyone in your family has had glaucoma and you are taking steroids, you should see an ophthalmologist soon!

I hope this ranting helped someone, Thanks
Bob

Please note I am only relaying my experiences and concerns.  I am not a doctor or pharmacist, and have no formal training in this area.  I'm just the patient and customer!

I suppose I should probably consult with one of the mesothelioma class action information sources or asbestos class action lawsuit firms regarding any class action, it seems they would be very experienced.
Google search for > Class Action Mesothelioma
Google search for > Class Action Accutane

Accutane appears to be another high volume suit probably with experienced firms.

Topic: A discussion of considerations for some type of lawsuit, perhaps a class action lawsuit with regard to the manufacturers of certain inhaled steroid products primarily used for the control of allergic reactions.  http://class action/ , http://glaucoma , http://mesothelioma