MONROE - The U.S. Food and Drug Administration sent warning letters Oct. 28 to Bayer HealthCare for illegally marketing two unapproved, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
Rita Chappelle, media spokesperson for the FDA, said Monday that letters sent to the Bayer company highlighted the concerns FDA has about the marketing and labeling of the products.
The FDA also released the information to consumers.
Consumers have expectations and those familiar with the brand name "don't know these drugs are not FDA approved," Chappelle said.
The products are "not safe nor effective," based on the claims in marketing and labeling," Chappelle said.
Both products have been found on drug store and pharmacy shelves in Monroe.
The pharmacy at Walgreens has not received any recall notices from the FDA, Bayer or Walgreens corporate offices in Deerfield to pull the products from the shelves yet.
The pharmacy at Monroe Clinic said it will wait until a recall notice has been issued.
Bayer has 15 days to respond to the FDA and address how it will deal with the warnings.
Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.
The FDA is concerned that customers will take the over-the-counter pills without clinical diagnosis, thinking they are treating a medical problem, Chappelle said.
"It is the health risks that are most troubling," Chappelle said.
Chappelle said any "house claims" in marketing or labeling that a product will "treat, prevent, or cure" need an FDA evaluation and clinical trials before approval.
Neither product has been approved by the FDA for such uses.
Bayer with Heart Advantage contains 81 mg of aspirin and 400 mg of phytosterols. The packaging call it "the only product that contains aspirin, to protect your heart by keeping your blood flowing freely; and phytosterols, to help lower bad cholesterol." Directions call for one caplet to be taken twice a day for phytosterols.
The products also are misbranded because their labelings do not have adequate warnings and are misleading. The labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.
Bayer Women's is also labeled for use in "fighting" osteoporosis. The calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis. Products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval.
"Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said.
Chappelle said too much aspirin can be harmful to kidneys.
The FDA warning say Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for an OTC drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional.
The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses.
The direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.
The drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter.
The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug.
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."
Rita Chappelle, media spokesperson for the FDA, said Monday that letters sent to the Bayer company highlighted the concerns FDA has about the marketing and labeling of the products.
The FDA also released the information to consumers.
Consumers have expectations and those familiar with the brand name "don't know these drugs are not FDA approved," Chappelle said.
The products are "not safe nor effective," based on the claims in marketing and labeling," Chappelle said.
Both products have been found on drug store and pharmacy shelves in Monroe.
The pharmacy at Walgreens has not received any recall notices from the FDA, Bayer or Walgreens corporate offices in Deerfield to pull the products from the shelves yet.
The pharmacy at Monroe Clinic said it will wait until a recall notice has been issued.
Bayer has 15 days to respond to the FDA and address how it will deal with the warnings.
Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.
The FDA is concerned that customers will take the over-the-counter pills without clinical diagnosis, thinking they are treating a medical problem, Chappelle said.
"It is the health risks that are most troubling," Chappelle said.
Chappelle said any "house claims" in marketing or labeling that a product will "treat, prevent, or cure" need an FDA evaluation and clinical trials before approval.
Neither product has been approved by the FDA for such uses.
Bayer with Heart Advantage contains 81 mg of aspirin and 400 mg of phytosterols. The packaging call it "the only product that contains aspirin, to protect your heart by keeping your blood flowing freely; and phytosterols, to help lower bad cholesterol." Directions call for one caplet to be taken twice a day for phytosterols.
The products also are misbranded because their labelings do not have adequate warnings and are misleading. The labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.
Bayer Women's is also labeled for use in "fighting" osteoporosis. The calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis. Products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval.
"Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said.
Chappelle said too much aspirin can be harmful to kidneys.
The FDA warning say Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for an OTC drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional.
The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses.
The direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.
The drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter.
The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug.
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."