Warnings for People with Hepatitis C and Liver Disease

Toxic Oil Bought Via Internet

[© 1997, Reuters Health eLine]

NEW YORK (Reuters) -- A report in this week's issue of The New England

Journal of Medicine tells of a 31-year-old man who was poisoned after

drinking a substance he purchased through the Internet.

The toxic liquid was essential oil of wormwood, the active ingredient of

the liqueur absinthe, a "tart" drink of "dazzling blue-green color" popular

in the 1800s, and favored by artists and writers such as Vincent van Gogh,

Henri de Toulouse-Lautrec, and Oscar Wilde say researchers at George

Washington University Medical Center in Washington, D.C.

Although absinthe -- a distillation of wormwood, alcohol, herbs, and seeds

-- is illegal in the United States, that did not prevent the patient from

finding a description of the drink on the World Wide Web. He then ordered

oil of wormwood over the Internet from a commercial provider of oils used

in aromatherapy.

"He drank about a thimbleful of the essential oil, like a liqueur, assuming

it was absinthe," says one of the report's authors, Dr. Paul Kimmel, a

professor of nephrology at the university.

Several hours later, the patient's father found him at home in an agitated,

incoherent, and disoriented state. Paramedics were called, and they noted

that the man suffered muscle seizures and decorticate posturing -- a sign

of potential brain damage.

In the hospital, after having been calmed with a potent anti-psychotic

drug, the man complained of soreness in his legs. Blood tests indicated

muscle tissue destruction. He was also diagnosed with congestive heart

failure and kidney failure.

The patient survived and was discharged from the hospital eight days after

admission. Seventeen days after becoming ill, the man had no further

symptoms and his blood tests returned to normal.

"While the Internet is touted as a great source for health information, it

also can be the source for health-damaging products," Kimmel warns.

"Consumers need to be extremely cautious before buying any health product

or recreational product through the Internet."

In the mid-19th century, physicians published reports on absinthism, "a

syndrome of hallucinations, sleeplessness, tremors, convulsions, and

paralysis associated with long-term ingestion of the liqueur," write the

report authors.

Claiming that absinthe contributed to psychosis and suicide, France banned

the drink in 1915, followed by other European nations and the United

States. But it is still a popular drink in the bars of the Czech Republic.

"The essential ingredient in this ancient potion was purchased in this case

by means of up-to-the-minute technology," they note. "Should the medical

community brace itself for future cases of Internet-mediated toxic diseases?"


SOURCE: The New England Journal of Medicine (1997;337:825-827)

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FDA TALK PAPER- SELDANE LABELING CHANGES

Food and Drug Administration

U.S. Department of Health and Human Services

Public Health Service 5600 Fishers Lane Rockville, MD 20857

------------------------------------------------------------------------

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in

responding with consistency and accuracy to questions from the public on

subjects of current interest. Talk Papers are subject to change as more

information becomes available.

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T97-47

Ivy Fleischer Kupec: 301-827-6242

Sept. 24, 1997

Broadcast Media: 301-827-3434

Consumer Inquiries: 800-532-4440

SELDANE LABELING CHANGES

The makers of the antihistamine Seldane and the antihistamine/decongestant

Seldane-D, are adding new warning information to the products' labeling.

Terfenadine-containing products, such as Seldane and Seldane-D, have long

been associated with severe risks when taken with certain antibiotics and

antifungals.

The new labeling provides information about a new contraindication of

simultaneously using Seldane/Seldane-D with the recently approved

hypertension drug, Posicor (mibefradil dihydrochloride). The new labeling

also provides additional warnings against using Seldane/Seldane-D with a

number of other newer drugs. These include: HIV protease inhibitors such as

Crixivan (indinavir), Norvir (ritonavir), Invirase (saquinavir) and

Viracept (nelfinavir), and serotonin reuptake inhibitors such as Luvox

(fluvoxamine), Zoloft (sertaline), Serzone (nefazodone), along with the

additional medications Zyflo (zileuton), Propulsid (cisapride) and Zagam

(sparfloxacin). Additionally, the new labeling specifies that patients with

renal difficulties should not take more than one Seldane/ Seldane-D tablet

daily and that Seldane/Seldane-D should not be taken with grapefruit juice.

In January, FDA proposed removing all terfenadine products from the

marketplace because of the approval of a safer alternative drug: Allegra

(fexofenadine hydrochloride). Fexofenadine hydrochloride provides the

benefits of terfenadine, but it does not cause a potentially fatal heart

condition when taken with some other commonly prescribed medications.

The new warnings are designed to give health care providers and consumers

who still use terfenadine-containing products the latest available

information about these risks, while FDA continues with the process to

remove these products from the market. In the event of terfenadine-related

adverse events, health care providers are urged to contact the

manufacturer, Hoechst Marion Roussel Inc., at 1-800-633-1610 or FDA

MedWatch at (phone) 1-800-FDA-1088, (fax) 1-800-FDA-1078, (modem)

1-800-FDA-7737 or (mail) FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.

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