Some Aspirin Products Not Approved by FDA ... Yet

There was an interesting article in HealthDay News.com that the U.S. Food and Drug Administration warned Bayer HealthCare that they were illegally marketing two unapproved over-the-counter aspirin medications, (Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage)

The article went on to say that they require an approved new drug application in order to be legally marketed. In addition to being labeled as pain relievers, both products claim to reduce the risk of heart disease. Bayer Women's also claims to fight osteoporosis. Neither product has been approved by the FDA for such uses.

Bayer Heart Advantage combines aspirin and phytosterols, which the label claims helps lower cholesterol levels. Bayer Women's combines aspirin and calcium carbonate.

FDA officials said they weren't aware of any significant adverse events associated with Bayer Women's or Bayer Heart Advantage.

Forbes reported Tuesday that Bayer stood behind both products' claims and said they were not intended to replace professional medical advice. Bayer also said it would respond to the FDA letters in the next 15 business days, as requested by regulators.

It reminds me of the time when ephedra supplements had to be withdrawn from the market in 2004 when the FDA’s final rule banning all dietary supplements containing ephedrine alkaloids, regardless of the recommended dose, came into effect. The ban was lifted a year later in April of 2005.

So, until all the inspections, detections, rejections, and all the other mean, nasty, ugly, stuff is settled, you might want to choose an alternative supplement. If you are currently taking a low dose of aspirin for your heart, and your physician says you also need more calcium for your bones, or your cholesterol is high, you might want to find a something else that has already been tested and determined to be safe.