FDA Warns Bayer About Two Unapproved Aspirin Products
Questions and Answers for Consumers
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What action is FDA announcing?
On Oct. 28, 2008, the Food and Drug Administration (FDA) sent warning letters to Bayer HealthCare regarding two over-the-counter (OTC) products that combine aspirin with a dietary supplement into a single pill. The products are not approved by FDA.
Which products are affected?
- Bayer Aspirin with Heart Advantage (Bayer Heart Advantage)–aspirin combined with phytosterols (a plant-based supplement also known as plant sterols)
- Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's)–aspirin combined with calcium
Why is FDA issuing these warning letters?
In addition to marketing these products as pain relievers, Bayer is also marketing them for reducing the risks of heart disease. The labeling for Bayer Women's also claims that the product helps "fight" osteoporosis.
- The products are unapproved new drugs. Because these products combine aspirin with a dietary supplement into one pill, FDA considers them to be new drugs that must undergo FDA review before they can be marketed. Their safety and effectiveness for their marketed uses have not been reviewed by the agency.
Under the OTC Drug Review–a process that lays out ingredients and uses that are allowed in OTC products–FDA allows some drugs to be marketed without first obtaining formal agency approval. But Bayer Heart Advantage and Bayer Women's are not covered by FDA's OTC Drug Review, nor are they otherwise approved by the agency.
- Bayer is marketing the products over-the-counter, but their use requires a physician's supervision. Products that are being marketed for preventing heart attacks, for preventing and/or treating heart disease, and/or for treating osteoporosis require the supervision of a physician to ensure safe use.
- The products have inadequate and misleading directions and warnings. Both products lack adequate directions and warnings for their safe use by consumers. For example, these products are labeled with directions and warnings that are inconsistent and contradictory.
The "Drug Facts" panels on the labeling for these products specify that consumers should stop use and ask a doctor if pain gets worse or lasts more than 10 days. But the "Supplement Facts" panels on the labeling for these products include directions for daily use, without mentioning any limitations on duration of use.
Have there been adverse events related to these products?
FDA is not aware of significant adverse events related to these products. But the agency is concerned because Bayer Heart Advantage and Bayer Women's have not been proven safe and effective for their labeled uses.
What is FDA's advice for consumers who may have been taking these products?
FDA has not approved these products. The agency recommends that consumers talk with their health care providers about alternatives to taking an unapproved drug. Consumers who are taking any aspirin products for cardiovascular health should only do so under the supervision of a physician.
Why is it important to use aspirin products under the supervision of a physician?
Studies have shown that aspirin can help prevent the recurrence of heart attacks and stroke, but aspirin use has also been associated with adverse events. These include gastrointestinal side effects, such as stomach pain, heartburn, nausea, vomiting, and bleeding. Also, using aspirin for cardiovascular health may not be necessary or appropriate for some people.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information
FDA Press Release: FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
www.fda.gov/bbs/topics/NEWS/2008/NEW01907.html
Is It Really FDA Approved?
www.fda.gov/consumer/updates/approvals093008.html
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Date Posted: October 28, 2008
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