CSPI Calling on FDA to Issue Warning Label for Supplements with St. John’s Wort

St. John’s wort is a flowering plant often promoted for its supposed antidepressant properties. But CSPI said that individuals who take it with prescription antidepressants may unwittingly be counteracting the very treatment they are seeking.

Nov 11 2011 --- Dietary supplements containing St. John’s wort may interfere with birth control, antidepressants, blood thinners, and other prescription and over-the-counter drugs. For that reason, the nonprofit Center for Science in the Public Interest has called on the Food and Drug Administration to require a warning label on those products.

St. John’s wort is a flowering plant often promoted for its supposed antidepressant properties. But CSPI said that individuals who take it with prescription antidepressants may unwittingly be counteracting the very treatment they are seeking. Similarly, women taking St. John’s wort and oral contraceptives may have unplanned pregnancies.

According to the National Center for Complementary and Alternative Medicine, part of the National Institutes of Health, St. John’s wort may also interact with other potentially life-saving treatments, including heart medications, drugs used to control HIV infection, drugs used to treat cancer, and seizure-control drugs. Writing in the Journal of the American Medical Association, former FDA Commissioner Jane E. Henney warned that St. John’s wort “interacts with many drugs that are used to treat heart disease, depression, seizures, certain cancers, as well as drugs that prevent transplant rejection and pregnancy.”

“Consumers take St. John’s wort and other herbal supplements based on their belief that they will benefit in some way, and perhaps some will,” said CSPI senior nutritionist David Schardt. “But all consumers need to know that St. John’s wort and many commonly prescribed drugs simply don’t mix.”

The petition suggests the following warning label: “CAUTION: St. John’s wort interacts with some commonly used prescription and over-the-counter drugs. DO NOT USE this supplement if you are taking contraceptives, antidepressants, immunosuppressants (such as cyclosporine), anticoagulants, Digoxin, HIV medicine, blood thinners, seizure-control medicine, cancer medicine, or any other medications.” The petition also asks that this warning appear in a prominent black box on the package label.

"Companies have taken a minimalist approach designed to protect themselves from litigation, rather than actually protecting consumers' health," said CSPI litigation director Stephen Gardner. "FDA should mandate a standard warning label for St. John’s wort to protect consumers based on the research outlined in this petition."

According to CSPI, the current advice on labels is inconsistent and fails to adequately warn consumers of the risks associated with St. John’s wort. Bluebonnet Herbals St. John’s Wort Extract does not have a warning label. Labels for Nature’s Plus Herbal Active St. John’s Wort Extended Release say “If you are pregnant or nursing, consult your healthcare physician before using any herbal product.” Vitamin Shoppe’s labels plainly state that “St John’s wort should not be used with antidepressants,” but does not address other drugs. Solaray labels merely advise consumers to “consult your physician.”

“From the information we have gathered, it appears that many manufacturers simply wish to protect themselves from product liability suits by placing boilerplate warnings on the label rather than actually alerting consumers to the known, material risks of drug interactions associated with the product,” CSPI says in its filing.

Source: CSPI