Even more alarming, the multivitamin could do more harm than good: two studies reported that selenium supplements may increase the risk of diabetes.
The Center for Science in the Public Interest (CSPI) initially contacted Bayer in June of this year to demand that the drug maker alter the marketing and labeling of its multivitamins. Eight months earlier, the largest prostate cancer prevention trial ever conducted reported that selenium supplementation does not prevent prostate cancer. CSPI called Bayer's claims of selenium benefits for men in fighting prostate cancer "astounding" and "deceptive."
In October 2008 the National Cancer Institute (NCI) and other institutes that comprise the National Institutes of Health showed in study data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT) that selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer.
One day after CSPI contacted Bayer, the FDA issued a letter stating in part that it was "highly unlikely that selenium supplements reduce the risk of prostate cancer." The same day, a spokeswoman for Bayer Healthcare wrote in an e-mail message that the company had not yet been served with or reviewed the lawsuit.
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As of October 2, packages of One A Day Men's Health Formula have not been recalled. The label reads: "One A Day Men's Health Formula is a complete multivitamin plus key nutrients including Selenium to support a healthy prostate".
According to Information Resources, a market research firm, One A Day Men's Health Formula had sales of $23.3 million for the 52 weeks ending Sept. 6.
Except for skin cancer, prostate cancer is the most common type of cancer in men in the United States. In 2008, 186,320 new cases of prostate cancer and 28,660 deaths from this disease in the US was estimated.