The U.S. Food and Drug Administration sent a warning letter to Bayer Health Care saying the company never received approval to sell two aspirin products –Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage). These products are aimed at fighting heart disease and osteoporosis.

“These are not FDA-approved products,” agency spokeswoman Rita Chappelle said. “They are selling products that are illegal.”

The FDA warned that treatments for heart disease and osteoporosis must be reviewed by government scientists and cannot be sold over the counter. Doctors traditionally prescribe aspirin to treat aches and pains and as a blood thinner for patients with heart disease.

The agency allows traditional pain relievers to be sold over-the-counter without review, as long as they include standard directions and labelling for consumers. But Bayer’s drugs are misbranded as their labelling lacks proper directions of usage. The agency said these products overstepped the regulations by claiming that the added ingredients in each medicine help fight specific diseases: Bayer Heart Advantage’s label claims that the drug “lowers cholesterol,” while Bayer Women’s label says the drug “fights osteoporosis.” However, taking aspirin long-term should be under a doctor's supervision, as the medicine is meant for short-term use. The drug can cause serious side effects like gastrointestinal bleeding. Studies have shown that patients who are resistant to aspirin are four times more predisposed to have heart attack, stoke, or even die from a pre-existent heart condition.

Bayer Aspirin with Heart Advantage contains aspirin mixed with the plant extract phytosterois, which the label claims it helps control cholesterol.

The statements on the labelling are confusing and send consumers a mixed message about the purpose of the product, the FDA wrote in the warning letter.

Bayer stands behind its products and marketing and says that no major negative reactions have been reported with the drugs. “Bayer is in the process of reviewing the letters and will respond to the FDA. Consumers [should] check with their physicians to determine if the product is right for them,” the German drugmaker said in a statement. The products were not intended to replace professional medical advice, the company added. The company said it would respond to the letters in the next 15 business days, as requested by the agency.

The FDA said the drugmaker’s actions violated the agency’s policies and urged the company to take prompt action or else face legal action. Bayer’s marketing of its Heart Advantage aspirin is also the subject of a congressional investigation. The company already faces lawsuits from federal officials and from patients for putting Trasylol in the hands of doctors. The medicine was used in the coronary artery bypass surgery procedure to prevent a patient from having bleeding complications. As a major side effect, kidney problems developed with a few cases were life ending. The drugmaker suspended sales of Trasylol last fall, after a Canadian study was halted because of higher incidence of deaths among patients taking it.