The U.S. Food and Drug Administration (FDA) has sent a letter to German-based pharmaceutical giant Bayer, already under fire over the Trasylol scandal, and is accusing the drug maker of misbranding, mislabeling and confusing customers about two of its over the counter products - Bayer Women's Low Dose Aspirin & Calcium and Bayer Aspirin with Heart Advantage.

What Bayer is saying

Here's how Bayer Health Care, a subsidiary of Bayer, is branding and labeling these products:

• Bayer Women's Low Dose Aspirin & Calcium

  According to Bayer's website, the drug "is specifically developed for women on an aspirin regimen as directed by a doctor who need a head start on their daily calcium requirements." In particular, Bayer says that:

  The product addresses two major health threats facing American women today - heart disease and osteoporosis. Bayer Women's Aspirin plus Calcium combines 81mg of aspirin - the lowest strength available that can provide the lifesaving benefits of aspirin - with as much calcium as in an 8oz glass of milk (300 mg elemental calcium) to help reduce the risk of osteoporosis.

• Bayer Aspirin with Heart Advantage

  According to Bayer's website, http://www.bayeraspirin.com/products/ar/ar_bha.htm, the drug has been shown to reduce the risk of heart attack up to 30% when taken regularly as directed by a physician. In particular, Bayer advertises the benefits of plant-based supplements contained in the product:

  Phytosterols, a natural plant-based supplement also known as plant sterols, are clinically proven to lower bad (LDL) cholesterol, which may help reduce the risk of heart disease. Bayer Aspirin with Heart Advantage can be appropriate for patients who are already on a doctor-recommended aspirin regimen and who are concerned about their cholesterol.

Why the FDA says it's not allowed…

In a nutshell, the FDA is saying that because the drugs are "more than just aspirin," they fall under a different category of drugs and are therefore subject to greater scrutiny under the FDA's guidelines. The FDA has given Bayer 15 days to advise it of the steps it has taken to correct the violations and has threatened the drug maker with legal action without further notice, including, without limitation, seizure and injunction.

If you've been injured due to a dangerous drug, contact an experienced attorney whose practice focuses in the areas of personal injury, products liability, medical malpractice or any other practice area to discuss your situation. Consultations are free, without obligation and are strictly confidential.