Healthy Skepticism Library item: 14576

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Kmietowicz Z.
FDA warns Bayer about illegally marketing two over the counter products containing aspirin
BMJ 2008 Nov 4; 337:
http://www.bmj.com/cgi/content/full/337/nov04_3/a2402

Abstract:

The German drug giant Bayer has been sent warning letters by the US
Food and Drug Administration for illegally marketing and “misbranding”
two of its products.

Bayer Women’s Low Dose Aspirin with Calcium and Bayer Aspirin with
Heart Advantage contain aspirin with either calcium or phytosterols in
single tablets. They are sold over the counter and labelled as helping
to reduce the risk of heart disease and “fight” osteoporosis, but
neither product has been approved by the FDA for these uses in the
United States. The only approval they have is for use as an analgesic.

Because both products are labelled as a combination of a drug and
dietary supplement in a single tablet the FDA requires them to be
regulated as a drug.

In addition, because heart disease and osteoporosis need to be
diagnosed and supervised by a healthcare professional, the FDA says
that the drugs cannot be sold over the counter.

“The FDA considers these products new drugs, and thus they must
undergo the FDA’s drug approval process,” said Mike Chappell, the
agency’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.”

The FDA has also ruled that the two products are misbranded, because
their labels do not carry adequate directions or warnings about
safety.

In letters to Bayer the FDA describes the labelling as sending
consumers “a mixed message about the purpose of the product and the
duration for which it can be safely used.”

For example, warnings about aspirin appear only under the heading
“drug facts,” which implies that these apply only when the products
are used as an analgesic. But the advice that children should not take
aspirin because of the risk of Reye’s syndrome and the warning about
gastric side effects of aspirin are relevant whenever the products are
used, says the FDA. Labels for the aspirin in the products includes
directions and warnings about using them in the short term, but other
directions for the phytosterols and calcium promote the use of the
products every day without a time limit.

“The marketing of these unapproved drugs is troubling,” said Janet
Woodcock, director of the FDA’s Center for Drug Evaluation and
Research. “Because OTC [over the counter] drugs are widely used by
consumers, without supervision by a doctor or other healthcare
professional, the overuse or misuse of these aspirin containing
products can put consumers at risk of internal bleeding and other
adverse events. It is essential that companies obtain FDA approval and
fully comply with FDA regulations.”

Helmut Schaefers, head of communications at Bayer, said that the
company is reviewing the letters and will respond to the FDA by the 17
November deadline. He added, “The company stands behind the products
and the claims made in them.”

Companies that do not resolve the issues in the FDA’s warning letters
risk enforcement action, such as injunctions or seizure of illegal
products.