The Food and Drug Administration in US has issued warning letters on Tuesday to Bayer Healthcare alleging illegal marketing of aspiring medications over the counter, which are unapproved.
The two drugs which include the Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium have to be approved with new drug application in order to be legal according to the FDA.
Both these drugs claim to reduce the risk of heart disease apart from relieving pain. The drug for women also claims to treat the condition of osteoporosis. These claims are dubious since the FDA has not yet approved them.
The agency went on to say that these drugs should not be marketed as is over the counter unless they are diagnosed and supervised by health care professionals. The Bayer Heart Advantage claims to lower levels of cholesterol with a combination of phytoserols and aspirin. Bayer Women’s combines calcium carbonate and aspirin.
Enforcement action will be taken against manufacturers who do not follow rules and violate the laws, which stipulate that any new drug introduced must pass through FDA’s process of approval according to the acting associate commissioner for regulatory affairs of the FDA, Mike Chappell.
Labeling in the Bayer Heart Advantage and Bayer Women’s is also found lacking in crucial usage information for customers says FDA. This makes it impossible for consumers to reach out and use these drugs in a safe manner without consulting their doctors.
FDA in their letters has warned Bayer of enforcement action including seizure of products, which are illegal, and injunctions.
