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A family of six in California became the first recipients in the United States of an intravenous milk thistle (Silybum marianum) fruit (seed) extract to treat mushroom poisoning in January.1,2 The US Food and Drug Administration (FDA) permitted emergency use of the drug Legalon SilŪ (Madaus Pharma, Brussels; div. of Madaus AG, Cologne, Germany) for the patients, and 5 of the victims survived the poisoning.
The 6 family members, who have not been identified in the media, became ill after eating tacos made with wild mushrooms, which they picked from the Wilder Ranch State Park in Santa Cruz, CA, on New Year’s Day.1 Doctors at Dominican Hospital in Santa Cruz soon determined that the patients were suffering from amatoxin poisoning, which is caused by eating poisonous mushrooms such as the “death cap” (Amanita phalloides) mushroom, and which can shut down liver function over a period of days.
Todd Mitchell, MD, a physician at Dominican Hospital, knew of no “ironclad” antidote for mushroom poisoning, and he used the Internet search engine Google Scholar to look for promising treatment options. He thus discovered references to milk thistle and its beneficial effects on the liver. He further learned that the phytopharmaceutical company Madaus Pharma, based in Brussels, Belgium, produces Legalon-Sil, an intravenous preparation made of silibinin, one of the flavonolignans in milk thistle extract. Dr. Mitchell called the company’s office in Germany, where the drug is approved for use, and the company agreed to donate enough Legalon to treat all 6 family members.
Before the drug could enter the United States, it had to receive an emergency IND (Investigational New Drug) number from the FDA, identifying it as an investigative new drug. While waiting to hear from the FDA, the staff of Dominican Hospital prescribed oral milk thistle extract supplements (Bio-SilymarinTM, Aloha Medicinals Inc., Haiku, HI) to the patients. The FDA granted Legalon an emergency IND number the same day that the agency received the request from Dominican Hospital. “Surprisingly [Mitchell] was able to get this within a matter of hours,” said Joe Veilleux, RPh, president of EuroMed, a Madaus subsidiary in the United States, according to an article in the Santa Cruz Sentinel.1 “People were asking me, ‘What are the chances he’ll get permission?’ I said one in 1,000.”
Once approval was given, Madaus shipped the medication by personal courier to the United States. The patients were treated with Legalon-Sil, in combination with penicillin, activated charcoal, and an antidote for Tylenol overdose. Five of the patients have been released from the hospital and were progressing towards full recovery, according to reports in January.1,2 The oldest poisoning victim, an 83-year-old woman, died of kidney failure. “The one victim who died was actually showing signs of liver recovery at her time of death, but she was very old and her kidneys gave out before she could fully recover,” said Mr. Veilleux (e-mail, February 9, 2007). “I think the encouraging part is that despite her age and frail condition, her liver function was improving because of her treatment, and unfortunately factors other than her liver resulted in the final complications.”
Dr. Mitchell informed the American Botanical Council that he has met with the head of the Poison Control Center and that they are hoping to work with the FDA toward obtaining the drug’s approval to make it more readily available in the United States (T. Mitchell, oral communication, February 20, 2007). Mushroom poisoning sent nearly 400 people to the hospital in California in 2006.
Legalon extract, the world’s first pharmaceutical-grade milk thistle extract, is made from the fruits (often called seeds) of milk thistle, standardized to 80% flavonolignans (silibinin [silybin], silydianin, and silychristin). Numerous published animal studies and human clinical trials have shown that milk thistle extract is safe, has antioxidant properties, assists in regeneration of RNA (ribonucleic acid) in the liver to create new hepatocytes, and eliminates toxins from the liver. The leaves of milk thistle, native to the Mediterranean area, have been used both as an edible plant and as a liver remedy in traditional medicine since Greco-Roman times. An extensive therapeutic monograph on milk thistle is available in The ABC Clinical Guide to Herbs (American Botanical Council, 2003).3
-Courtney Cavaliere
References
1. Gumz J. A life-or-death situation: family poisoned by mushrooms first to receive experimental treatment. Santa Cruz Sentinel. January 14, 2007. Available at: http://www.santacruzsentinel.com/archive/2007/January/14/local/stories/01local.htm. Accessed February 7, 2007.
2. Russomanno T. Thistle saves Santa Cruz mushroom poison victims. CBS 5. January 19, 2007. Available at: http://cbs5.com/health/local_story_019214119.html. Accessed February 7, 2007.
3. Blumenthal M, Hall T, Goldberg A, Kunz T, Dinda K, Brinckmann J, Wollschlaeger B. The ABC Clinical Guide to Herbs. Austin, TX: American Botanical Council; 2003.
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