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FDA warns Bayer about illegally marketing two over the counter products containing aspirin

BMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a2402 (Published 04 November 2008) Cite this as: BMJ 2008;337:a2402
  1. Zosia Kmietowicz
  1. 1London

    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 …

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