To support its position in the filing, CSPI pointed to information from the National Center for Complementary and Alternative Medicine, part of the National Institutes of Health, which stated 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. CSPI also drew attention to former FDA Commissioner Jane Henney’s warning in the Journal of the American Medical Association 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.”
According to CSPI, the proposed black box warning would read “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.”
CSPI said it examined 11 St. John’s wort-containing supplement products, with respect to their cautionary statements, and noted an insufficient degree of disclosure of interaction potential, thus hastening the need for an FDA-established, mandatory cautionary label. “Companies have taken a minimalist approach designed to protect themselves from litigation, rather than actually protecting consumers’ health,” said Stephen Gardner, CSPI’s litigation director. “FDA should mandate a standard warning label for St. John’s wort to protect consumers based on the research outlined in this petition.”
In its filing, CSPI further commented that based on the information it has gathered, it appeared
“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.”
As news of CSPI’s filing broke, Silver Spring, MD-based American Herbal Products Association (AHPA) issued a press release that pointed to a Guidance Policy it established in 2000 recommending that St. John’s wort products be labeled to suggest that consumers seek the advice of their physician if taking any prescription drug. AHPA also established a related Guidance Policy in October 2001 that recommended consumers disclose the use of any herbal supplements to their healthcare provider. As part of that policy, AHPA encouraged healthcare providers to seek out accurate and truthful information about herbs.
“CSPI has not discovered any new information, but is only acknowledging what AHPA has known for many years with regard to the possibility for some St. John’s wort ingredients to interact with certain drugs,” commented Michael McGuffin, AHPA’s president. “But this information is already disclosed through the broad use in the herbal trade of AHPA’s labeling policy for St. John’s wort, and we do not agree that a black box warning—generally limited to only the most dangerous drugs—is warranted.”
With a nod to CSPI’s history of “early and frequent” observations and criticisms of DSHEA, dietary supplement regulation and the dietary supplement industry, Loren Israelsen, executive director, of Salt Lake City, UT-based United Natural Products Association, agreed. “The black box is the biggest and most aggressive warning label found on Rx drugs,” he said. “If you get black-boxed in the pharma world, that’s a big deal.”
He also addressed the broad and sweeping nature of the proposal by saying, “CSPI does not specify any particular type of St. John’s wort or its extracts or any potency or amount. “It would appear that the presence of any St. John’s wort would, in CSPI’s mind, trigger a cautionary statement.”
As for preventing interactions between St. John’s wort and other drugs, AHPA’s chief science officer, Steven Dentali, PhD, said it is a shared responsibility that extends beyond just St. John’s wort. “Prescribers of medications need to inform patients of possible food-drug and herb-drug interactions,” he said. “Although specific drugs are not identified on the labels of grapefruit juice, leafy greens or St John’s wort extracts, it is widely known that these can affect drug metabolism. In the case of St. John’s wort, this concern is limited to certain constituents, as there is no indication that low-hyperforin products cause clinically significant drug interactions.”
Nutraceuticals World will continue to stay abreast of this story as it unfolds.