An Aspirin is an Aspirin; Or is It?
Posted by
Armand RossettiOctober 28, 2008 2:38 PMTags: FDA,
Bayer,
Women's Health,
Heart Advantage,
warning,
letter,
new,
drug,
calcium,
phytosterols cholesterol,
osteoporosis Today, the FDA released information concerning Bayer HealthCare's illegal marketing of two aspirin based drugs: Bayer Aspirin with Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium. It is well known in the health care field that a doctor recommended, daily low dose aspirin regimen (81 mg) can aid in preventing long term cardiovascular disease. However, by adding what would ordinarily be considered non-regulated dietary supplements to aspirin to arrive at Heart Advantage and Women's Low Dose, Bayer has gone a step further and created two entirely new drugs.
Bayer Heart advantage combines aspirin and phytosterols (for cholesterol reduction), and Bayer Women's combines aspirin and calcium carbonate (to fight osteoporosis). Whenever a manufacturer combines nutrients such as calcium or phytosterols with aspirin, those new combinations result in the creation of entirely new drugs that must undergo FDA approval. According to the FDA, Bayer is marketing products that claim to lower blood cholesterol, and that consumers may use thos new drugs to prevent or treat coronary heart disease. Therefore, Bayer cannot legally market these new over the counter (OTC) drugs to consumers without first submitting an approved FDA new drug application.
In addition, the FDA noted that Bayer's Heart Advantage and Women's Advantage both have inadequate and misleading directions and warnings. Without proper directions, consumers are not able to use those drugs safely for their intended purpose, and without supervision of a health care professional.
Bayer is not the first company to receive warning letters for combining drugs with nutrients and marketing them without FDA approval. Recently, the FDA issued warning letters to manufacturers of joint pain medications that marketed those products without first seeking FDA clearance. In a clear statement concerning manufacturer failure to seek preapproval before marketing new combination drugs, the FDA stated the following:
"Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States."