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Alternative Medicine Guidelines Could Make Supplements Safer
Plenty of people use kava to relieve stress, anxiety and insomnia. But in March the U.S. Food and Drug Administration linked the supplement to severe liver disease after a healthy 45-year-old who took kava suddenly became ill enough to require a liver transplant.
Some reports said kava should be taken off the market. Others said people without liver disease could continue to use it. Most of all, people were confused.
Now, a federal commission has come up with guidelines that, if adopted, would reduce the chances for an episode like the kava case.
The new report of the White House Commission on Complementary and Alternative Medicine Policy recommends changes intended to better ensure the safety of herbal and other supplements. The group also calls for more federal oversight of such products, which don't have to prove they work or are safe before they go on the market.
The commission's recommendations for dietary supplements are reasonable and well thought out. The group notes:
- "The public expects that products sold in the United States are safe." The group advises the FDA publish standards for safe manufacturing and require manufacturers to substantiate safety of their products.
- "Dietary supplement manufacturers and suppliers should be required to maintain and report serious adverse events to the FDA." Now, manufacturers don't have to tell the FDA if someone has a serious reaction or becomes seriously ill after using their products.
- "Manufacturers should have on file and make available information to substantiate their determinations of safety." Independent experts should develop a way to objectively evaluate the safety of dietary supplements.
More than 158 million Americans use dietary supplements. As more people use such products, simple probability tells us that somebody will have an adverse reaction. The commission's recommendation would give us data to clearly decide whether that bad reaction was a rarity or whether many other people were at risk.
If manufacturing standards for ensuring purity plus a system for evaluating adverse effects are in place, dietary supplements will, I believe, be proved to be far safer than most medications.
In the meantime, I cannot emphasize enough the importance of discussing dietary supplement use with a medical physician who is familiar with supplements. Be aware, however, that some practitioners who call themselves doctor have no formal medical training.
Also be aware, as the commission noted, that much information about dietary supplements - especially what is on the Internet - is inaccurate and misleading.
I take dietary supplements and I recommend them for my patients. I have personally visited manufacturing sites to ensure quality and purity of the products I recommend.
I hope, because of the efforts of the White House Commission on Complementary and Alternative Medicine Policy, all dietary supplements in the United States soon will be of the highest standards and quality.
- Patrick B. Massey, M.D., Ph.D., is medical director for alternative and complementary medicine for Alexian Brothers Hospital Network.
From Healthy.net