The two aspirin products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, are misbranded, mislabelled, and confusing to consumers, according to the FDA.

According to Bayer, its Women’s Low Dose Aspirin fights heart disease and osteoporosis with a combination of 81 mg of aspirin and the equivalent of an 8-oz glass of milk in calcium for possible “lifesaving benefits.”

Bayer Heart Advantage combines the same low dose of aspirin with plant phytosterols, molecular entities found in fruits and vegetables that are valuable for their cholesterol lowering properties.

While Bayer’s web site instructs users to talk to their doctors before beginning any aspirin regimen, the message isn’t so clear on the medicine’s packaging. Both Bayer medicines are packaged to appeal directly to consumers, who might be lead to think that they can treat their heart conditions, cholesterol, and osteoporosis with these OTC medicines.

The FDA requires that medicines designed to treat heart disease and osteoporosis be reviewed by its researchers. Federal law also forbids such medications to be sold OTC.

Labeling on Bayer’s Heart Advantage claims that the drug lowers cholesterol. Labeling for Bayer Women’s says that it fights osteoporosis. Improper use of medicines containing aspirin often causes serious side effects such as gastrointestinal bleeding. Aspirin resistance can also have devastating effects on the heart.

Bayer believes that neither products violate FDA regulations, but promises to review the case and report back to the FDA within 15 business days. The FDA indicated in its letter to Bayer that the company would face legal action.

Bayer is already under fire by the FDA and general public for its marketing of Trasylol when ample studies found the drug to be highly toxic to many people.

SOURCE: Trasylol Recall › FDA warns Bayer about two OTC aspirin products

Both complaints were filed in the St. Clair County Circuit Court.

Gary Harms received a Trasylol injection in 2005 while he was undergoing heart surgery at Des Peres Hospital in St. Louis, Missouri. He has since suffered from acute renal failure and requires regular dialysis to perform the functions of his failed kidneys.

Researchers first discovered a link between Trasylol and kidney failure in the early 1980s when lab animals that received the drug developed severe kidney failure. Subsequent tests confirmed Trasylol’s danger to humans, yet Bayer consistently denied the existence of a link between their drug and acute renal failure and death. The company also failed to fund and perform adequate clinical tests that would have conclusively demonstrated the drug’s risks.

Harms’ suit claims that he has suffered from emotional distress and anxiety, physical personal injury, medical expense, loss of consortium, services, love and affection, permanent loss of an important bodily function, permanent impairment of the ability to enjoy life and financial expenses. He seeks $550,000 in addition to attorney’s fees and other costs.

Richard Kopsie also received Trasylol during his coronary artery bypass graft surgery at Christian Hospital in St. Louis, Missouri in 1996. He experienced kidney failure shortly after surgery and required dialysis for years. Kopsie passed away in March 2003 at the age of 53, but his final years were marked by pain and suffering from Trasylol-induced injuries, medical costs, disability, and a diminished ability to enjoy life, according to the complaint filed by his wife Linda.

Linda Kopsie seeks a $1.1 million on 22 counts plus attorney’s feels and other costs against Bayer.

Both suits claim that Bayer acted negligently for continuing to market Trasylol when the drug’s dangers were known, for failing to alert the FDA to dangers of the drug, and failing to attach appropriate warnings and safety information to the drug. For years, Bayer also avoided performing large scale tests that would have effectively underscored the drug’s dangers.

SOURCE: Trasylol Recall › Two suits filed against Bayer in Illinois