why the warning on aspirin products?
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Question

I have a question regarding aspirin that neither my doctors, nor the nurses at my local diabetes education center have been able to answer. I have type 2 diabetes and was thinking about aspirin therapy for heart disease prevention.

As I read labels, I noticed that on every bottle of aspirin, regardless of strength or brand, is a warning that usually reads something like this:

Do not take this product if you are taking a prescription drug for (or; ...are being treated for...) ...diabetes (and a varying list of other problems as well) unless directed by a doctor.

Well, I am taking prescription drugs for my diabetes and, after consulting with my doctor, 81 mg aspirin daily. But, as I said, neither she nor anyone else has been able to explain the reasoning behind the warning on the aspirin products. They all simply dismiss it. Even the diabetes education professionals were at a complete loss! They had never been aware of these warnings. My doctor has said she will research it, but hasn't found the answer yet, so I'm trying on my own.

I just find it curious that this warning is on every aspirin product out there, and the medical community, even diabetes specialists, seems oblivious to it. Thank you for your consideration.

Answer

It would seem that this statement about aspirin use in diabetes is related to a drug interaction with the sulfonyurea group of diabetes pills. See, for instance, page 52 of a rather large PDF file titled Proposed Amendment to Final Rule for Professional Labeling of Aspirin by Bayer, posted on the FDA website, where it is stated in the section on Drug Interactions in a footnote about a sulfonylurea interaction:

Despite potential interactions between some anti-diabetic drugs and ASA [aspirin], the American Diabetes Association (ADA) advocates the benefits of ASA, particularly for use as a primary prevention strategy in men and women with diabetes who are at high risk for cardiovascular events (American Diabetes Association, 2002).

The ADA, in their 2004 statement about aspirin, in the safety section, doesn't mention any drug interactions of aspirin with "usual" diabetes therapy, stating:

Contraindications to aspirin therapy include allergy, bleeding tendency, anticoagulant therapy, recent gastrointestinal bleeding, and clinically active hepatic disease.

Reviewing some labels for diabetes drugs, I looked at one of the sulfonylureas, Amaryl, in whose label it is stated:

Coadministration of aspirin (1 g tid) and AMARYL led to a 34% decrease in the mean glimepiride AUC and, therefore, a 34% increase in the mean CL/f. The mean Cmax had a decrease of 4%. Blood glucose and serum C-peptide concentrations were unaffected and no hypoglycemic symptoms were reported. Pooled data from clinical trials showed no evidence of clinically significant adverse interactions with uncontrolled concurrent administration of aspirin and other salicylates.

On the other hand, the label for Glucophage, which is in a different class of diabetes drug, states that:

Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates [aspirin]… as compared to the sulfonylureas, which are extensively bound to serum proteins.

So, in conclusion, the warning on your aspirin bottle probably refers to a concern that one type of diabetes drugs (sulfonylureas) may have a theoretical interaction with aspirin resulting in change in blood sugar control. But it doesn't seem to be much of a problem in clinical practice, and could be easily verified by watching blood sugar levels.

Go ahead and take your aspirin!

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