Hold on a minute, Bayer...
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Two new Bayer products, both containing good ol’ aspirin plus a nifty supplement, beckon consumers with suggestions that they can reduce the risk of heart disease. One of them also says it can help fight osteoporosis.
Such products, and the claims about them, appear to have gone too far. The Food and Drug Administration politely pointed out today that the one-tablet combos amount to new drugs and, as such, require the agency’s approval before they can be sold or marketed in such a way. That approval has not been granted.
So what the agency has granted is warning letters, posted online, alleging illegal marketing and calling the products themselves unlawful. At issue are Bayer Aspirin with Heart Advantage, which contains aspirin and phytosterols, and Bayer Women’s Low Dose Aspirin + Calcium, which contains aspirin and calcium.
Says the agency’s news release:
‘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.’
Such warning letters are not exceptional, but they do suggest some response is needed. Beyond taking issue with the marketing, the agency also says the labels’ directions for use are more than a little problematic.
The website for Bayer Aspirin with Heart Advantage says: ‘Phytosterols, a natural plant-based supplement also known as plant sterols, are clinically proven to lower bad cholesterol, which may help reduce the risk of heart disease.’ Here’s its warning letter.
The website for Bayer Women’s Aspirin + Calcium says: ‘The product addresses two major health threats facing American women today -- heart disease and osteoporosis. Bayer Women’s Aspirin plus Calcium combines 81 mg of calcium -- the lowest strength available that can provide the lifesaving benefits of aspirin -- with as much calcium as in an 8 oz glass of milk (300 mg elemental calcium) to help reduce the risk of osteoporosis.’ Here’s its warning letter.
A company spokeswoman told Bloomberg News that it stands behind the marketing -- but that it would review the FDA’s letters.
For what it’s worth, both Bayer pages point out, in bold type: ‘Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin or modify an aspirin regimen.’
The American Heart Assn. is a firm supporter of aspirin use in heart attack and stroke prevention. And here’s some useful information from U.S. News & World Report on aspirin.
But the FDA wants to weigh in on the combo -- and the marketing.
-- Tami Dennis