February 21, 2012
The frequency of use of dietary supplements among the elderly is significantly higher compared with the general population. Given that a large proportion of the elderly also consume multiple prescription medications, there are much greater concerns for drug interactions and side effects due to concurrent consumption.
By themselves, adverse drug reactions are among the leading cause of hospitalization and death in this country. These statistics are compounded in the elderly population, who are more likely to be prescribed multiple medications by physicians on top of over-the-counter drugs and supplements. A 48-state phone survey conducted in 1998 and 1999 revealed that an average of 50 percent of men and women over age 65 were taking five or more prescription drugs a week; 12 percent were taking 10 or more. With these large numbers, the potential for drug interactions and side effects from adding supplements to already overloaded prescription regimens cannot be ignored.
The danger of dietary supplement contamination has been a hot issue. To address unsafe dietary supplement manufacturing, FDA promulgated a final rule on good manufacturing practices for dietary supplements in June 2007. It addressed a variety of concerns about the perils of poor manufacturing, including wrong ingredients and contamination. Failure to comply with the dietary supplement GMPs may lead to a company facing both civil and criminal penalties. Still, many dietary supplement manufacturers are not fully compliant with the GMPs.
With elderly populations increasing, especially those with limited incomes, it is likely that the number of elderly using dietary supplements will continue to increase. Avoiding lawsuits and maximizing profits are keys to successful marketing of any dietary supplement, but companies should pay particular attention to “specialty” populations, especially the elderly. Companies need to consider additional warnings that are large and likely to be seen by those with failing eyesight. Also, the content of warnings on labels and in labeling need to clearly address the importance of consulting a health care provider about potential interactions with prescription drugs and current conditions.
While FDA has specific guidance for geriatric labeling of prescriptions, no such guidance addresses marketing of dietary supplements. Companies looking to target their marketing for seniors should be advised to consider many of these issues in order to protect their investments.
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