Bayer Health Care in Trouble with FDA

Bayer Health Care has been warned about two over the counter aspirins by the US Food and Drug Administration. The aspirins contain supplements that say they are not only effective for pain relief but also against heart disease. Because of the labels and the supplements; the drugs should have been approved by the FDA. The two aspirins unapproved are Bayer Women’s low Dose Aspirin + Calcium(Bayer women’s) and Bayer Aspirin with Heart Advantage(Bayer Heart Advantage). The problem with these pills is that they contain two different things in the same tablet. Separately they can be labeled describing them as a drug and dietary supplement, but when they are put into one tablet they are subject to FDA regulation. The FDA is considering them new drugs and therefore must go through the FDA’s drug approval process. Bayer’s Women’s also claims to “fight” osteoporosis. The FDA says “the drugs are misbranded and since such uses take the products out of the OTC category because these conditions should be diagnosed by a health care professional.” The worry with these drugs is that OTC drugs are often misused and without supervision the products can put the consumers at a risk for internal bleeding or other adverse effects. A Bayer spokesperson told press that the company stands behind their products. They believe at the aspirin should be marketed as labeled. Bayer said “advertisements tell consumers to check with their health professional before taking aspirin with supplements” This just shows even drugs sold OTC can be dangers. A consumer has to know what they are taking and if it is what they need to be taking; it doesn’t just need to have a good label.
http://www.medicalnewstoday.com/articles/127229.php