New Safety Concerns about St. John's Wort

The following emails arrived on February 11th and 14th from the NIMH, reporting safety concerns arising in a clinical trial: they found drug-drug interactions of St. John's Wort (Hypericum) with indinavir and raised concerns about other similarly-metabolized drugs such as cyclosporine and some oral contraceptive medications.

Their interpretation of the data is that St. John's Wort induces hepatic enzymes with resultant lowering of serum levels of protease inhibitors and other drugs. The conseqences of this may be to reduce the effectiveness of antivirals against viral infections such as HIV, to precipitate organ rejection in the case of immunosuppressants, or for pregnancy to occur despite use of the contraceptive medication as directed.

The research report by Piscitelli, et al., can be found in the February 12th issue of The Lancet.

Any observations of worrisome drug interactions should be reported to the FDA's MedWatch program at 1-800-FDA-1088 (fax 1-800-FDA-0178).

Primary online sources can be found at:


Date: Fri, 11 Feb 2000 19:58:39 -0500
From: "Marshall, Louise (NIMH)" <lmarsha1@mail.nih.gov>
Subject: PUBLIC ALERT ON ST. JOHN'S WORT
Sender: owner-nimh-e-news@LIST.NIH.GOV
To: List NIMH-E-NEWS <NIMH-E-NEWS@LIST.NIH.GOV>
MIME-version: 1.0

The National Institute of Mental Health (NIMH) alerts the public to concerns
about interactions between St. John's wort, an herbal product used to treat
depression, and indinavir, a protease inhibitor, and perhaps other protease
inhibitors used in the treatment of HIV. Adverse interactions have also been
reported with cyclosporine, a drug used to reduce the risk of organ transplant
rejection and again possibly with other immunosuppressant drugs. St. John's wort
appears to lower the blood plasma level of protease inhibitors and
immunosuppressant drugs.

NIMH and  National Center for Complementary and Alternative Medicine are
conducting a clinical trial <http://hypericum.rti.org/index.html> of the safety 
and efficacy of St. John's wort.  Please view the NIH News Release 
<http://www.nih.gov/news/pr/feb2000/wgmcc-10.htm>
and FDA Public Health Advisory for Health Care Professionals 
<http://www.fda.gov/cder/drug/advisory/stjwort.htm>
for more information.

==================================================================

Date: Mon, 14 Feb 2000 13:36:17 -0500
From: "Marshall, Louise (NIMH)"  <lmarsha1@mail.nih.gov>
Subject: Revised Breaking News and Newest Items Added to the NIMH Website -
 February 14, 2000
Sender: owner-nimh-e-news@LIST.NIH.GOV
To: List NIMH-E-NEWS <NIMH-E-NEWS@LIST.NIH.GOV>
MIME-version: 1.0

Breaking News (Revised)

PUBLIC ALERT ON ST. JOHN'S WORT

Adverse interactions have been reported between St John's wort (hypericum), an
herbal product used to treat depression, and two drugs:  indinavir, a protease
inhibitor used to treat HIV and cyclosporine, a drug used to reduce the risk of
organ transplant rejection. Potentially dangerous changes in drug effects can
occur when medications such as cyclosporine (Neoral, Sandimmune), digoxin
(Lanoxin, Lanoxicaps) and warfarin (Coumadin) are taken with hypericum extracts.
Hypericum  extracts can decrease the blood levels of antiretroviral medications
that are used in the treatment of HIV infection, thus making these drugs less
effective. Recent data show that the plasma levels of the protease inhibitor
indinavir (Crixivan) were reduced by more than 50% by hypericum (St. John's
wort) products.

NIMH and  National Center for Complementary and Alternative Medicine are
conducting a clinical trial <http://hypericum.rti.org/index.html> of the safety 
and efficacy of St. John's wort.  Please view the NIH News Release 
<http://www.nih.gov/news/pr/feb2000/wgmcc-10.htm>
and FDA Public Health Advisory for Health Care Professionals 
<http://www.fda.gov/cder/drug/advisory/stjwort.htm>
for more information.
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