CSPI Wants St. John's Wort to Carry Warning Label

WASHINGTONThe Center for Science in the Public Interest wants FDA to require manufacturers to put warning labels on St. John's wort products that say the herb may interfere with birth control, antidepressants, blood thinners, and other prescription and over-the-counter  (OTC) drugs.

St. Johns wort (Hypericum perforatum) is a flowering plant often promoted for its 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. Johns wort and oral contraceptives may have unplanned pregnancies, according to CPSI.

According to the National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health (NIH), St. Johns 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 St. Johns 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."

The petition suggests the following warning label: CAUTION:  St. Johns 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. Johns wort to protect consumers based on the research outlined in this petition."

The American Herbal Products Association (AHPA) recommends its members add labels to St. John's Wort products that say, "Do not use this product while taking any prescription drug(s) without the advice of your prescribing physician. Avoid excessive exposure to UV irradiation (e.g., sunlight; tanning) when using this product," or something quite similar.

Steven Dentali, AHPAs chief science officer, noted the range and severity of side effects from prescription antidepressants are much greater than those reported with St. Johns wort (SJW) extracts. Depression can be a serious debilitating illness, and not all drugs or herbs, work the same on everyone. Whether SJW is an appropriate alternative to pharmaceutical drugs for depression depends on many factors. It may be appropriate for a mood-lightening effect for people with Seasonal Affective Disorder, but is should be kept in mind that the diagnosis and treatment of depression should involve a health care professional."

Further, Dentali said it is up to the prescriber of medications to properly inform the patient of interactions with foods, which includes supplements. He compared St. John's wort to grapefruit juice, which can affect drug metabolism. "Yet there are not any warning labels on grapefruit juice," he said.

 Also, while SJW is a real player and perhaps the only one so far, in the clinically significant herb-drug interaction arena, it should be kept in mind that formulations are available that dont affect drug metabolizing enzymes," Dentali said. "Not all SJW extracts are equivalent, in other words."