The Long Arm of the FDA

July 10, 2009
Anita Ramsetty

This week the news is abuzz with the potential FDA crack-down on some over-the-counter pain medications like Tylenol, as well as Tylenol-containing prescription medications.

This week the news is abuzz with the potential FDA crack-down on some over-the-counter pain medications like Tylenol, as well as Tylenol-containing prescription medications. In my endocrine clinic I do not prescribe these medications, but when I moonlight in the ER I do prescribe them quite a bit. Of course I understand the concern about these medications as well as possible misuse of Tylenol OTC, but I wonder where this trend may lead.

Currently a number of my patients use generic insulins that they can purchase at pharmacies for MUCH less than brand name insulin. There is no one on this planet who could argue that insulin is not potentially misused in a very dangerous way, and really is one of the most dangerous medications that can be purchased over the counter when you think about it. Several patients of mine who had previously lost insurance switched from their expensive insulins to over the counter regular insulin or NPH insulin. In some cases it was so much less expensive that when they regained their prior insurance, they still stayed with OTC insulin despite efforts to switch them to newer formulations that had more favorable pharmacodynamics.

With the rising numbers of individuals with diabetes in this country, as well as the current economic climate and job situation, I can foresee an increasing number of people switching to generic insulin even for a short term. With the rise in use will come a rise in reported adverse events; this is just the way it happens for everything. And then what? Will those insulins be pulled or limited as well?

The next culprit will be aspirin, which is widely used for various reasons and is part of the drug arsenal regimen for every type 2 diabetic on the planet. It is also standard for patients who have had or are at risk for stroke or CAD, a number that is staggeringly high and increasing every year. But we also know about GI bleeds and the potential risk of cerebral hemorrhage when taking aspirin, don’t we?

Some of you may say I am stretching this argument too far. Perhaps, but think for a moment if I am not: a number of our specialties rely on OTC meds for our patients. It helps keep down costs in some arenas, including office visits if patients can self-treat some conditions after discussing it with their doctors by telephone. And yes, “do no harm” is still at the top of our priority list, so cautions will have to be held high. But we need options in this ever-changing economic and healthcare climate. Hopefully the FDA can balance that aspect as well.