FDA Warns Bayer About Two Illegal Aspirins

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Cardiovascular / Cardiology;  Bones / Orthopaedics;  Women's Health / Gynecology
Article Date: 29 Oct 2008 - 0:00 PDT

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The US Food and Drug Administration (FDA) has written warning letters to drug company Bayer HealthCare about two over the counter (OTC) aspirins that contain supplements and claim to be effective not only for pain relief but against heart disease, and this constitutes a use for which the drugs have not been given approval and therefore makes them illegal said the agency in a statement on Tuesday.

The two aspirins are: Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

Bayer Women's has aspirin and calcium carbonate in a single tablet and Bayer Heart Advantage has aspirin and phytosterols in a single tablet. They both carry labels that describe them as being a drug and a dietary supplement, but when these are together in one tablet the product is subject to FDA regulation said the FDA.

Mike Chappell, the FDA's acting associate commissioner for regulatory affairs said in a statement that:

"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process."

Chappell said the federal agency was prepared to enforce action against manufacturers who broke the law or who tried to get around the drug approval process.

The two aspirins are labelled not only as pain relievers, but also carry claims that they reduce the risk of heart disease, said the FDA statement. Bayer's Women's also claims to "fight" osteoporosis. Neither of these uses is approved by the FDA. Moreover, the drugs are misbranded said the agency since such uses take the products out of the OTC category because these conditions should be diagnosed by a healthcare professional who then advises which medication to take and then supervises the patient on the drug.

Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said she was troubled by the marketing of these unapproved drugs.

"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."

"It is essential that companies obtain FDA approval and fully comply with FDA regulations."

The FDA said the labels also carry mixed messages about long versus short term use because the instructions for the aspirin content conflict with the instructions for the supplement content.

It would seem that part of the problem is in the wording. Claiming to fight a disease or directly claiming to lower cholesterol is not the same as claiming to reduce the risk of these conditions.

The label on the Bayer Heart Advantage product claims that the phytosterols are intended to lower blood cholesterol and the label on the Bayer Women's product claims that the calcium is intended to strengthen bones to "fight" osteoporosis.

Although some dietary supplements that contain calcium are allowed to claim to "reduce the risk of osteoporosis", claims to fight or treat the condition directly requires approval by the FDA. Similarly, some supplements containing phytosterols are allowed to claim they "reduce the risk of coronary heart disease" and may say they do this by lowering blood cholesterol, but a direct claim to lower cholesterol is the same as saying the drug prevents or treats coronary heart disease and hypercholesterolemia, for which FDA approval is necessary.

Not only should the company apply for new drug approval for such claims, but they would not be approved for OTC use anyway and to market them as such is another reason that makes them illegal, said the FDA.

There are some conditions under which the FDA allows OTC drugs to be marketed without first getting FDA approval but the agency said these two drugs do not meet the conditions because they do not comply with "set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed".

The FDA said it was not aware of any significant adverse events arising from use of these products.

According to Reuters, a Bayer spokesperson told the press that the company stands by both products and defends its right to market them as labelled. The drug company said advertisements tell consumers to check with their health professional before taking aspirin with supplements, and the label on the Bayer Aspirin with Heart Advantage also says it does not replace cholesterol-lowering medication.

Sources: FDA, Reuters.

Written by: Catharine Paddock, PhD.


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