Madaus Inc, a division of Madaus GmbH (Cologne,
Germany), is making its
mushroom poisoning antidote Legalon® SIL available for the first
time in the USA.
The drug will be provided at no charge to treat patients with suspected
amatoxin poisoning due to the ingestion of Amanita phalloides or other amatoxin
containing mushrooms. Madaus Inc will sponsor a clinical evaluation of Legalon®
SIL via an FDA sanctioned Open Treatment IND and physicians can obtain the
medication by contacting a 24 hour hotline (toll free # 866-520-4412). Amatoxin Mushroom Poisoning (AMP) Amanita phalloides (aka Death Caps) and other amatoxin
producing mushrooms (A. ocreata, A. bisporigera, A. virosa, Galerinas,
Lepiotas) are often mistaken for safe edible mushrooms in the wild. They are known to taste very good and initial
symptoms are delayed by six hours or more.
Within 24 hours of ingestion patients develop a syndrome similar to food
poisoning with severe diarrhea and vomiting. Depending on the amount ingested
and the degree of dehydration at presentation, fulminant hepatic and renal
failure may ensue resulting in death or the need for liver
transplantation. Current Treatments The approach to AMP includes intensive supportive care with fluid and electrolyte replacement, and activated charcoal to bind toxin in the gut. Measures to address the complications of liver and renal failure may also be required. Several remedies that have little support in the medical literature also continue to be used including intravenous penicillin, high dose steroids, thioctic acid, N-acetylcysteine, cimetidine etc. Liver transplant may be offered to the sickest patients. The mortality following amatoxin ingestion remains disturbingly high.
Legalon® SIL (Silibinin-C-2’, 3-dihydrogen succinate disodium salt) Legalon® SIL is a highly purified intravenous (IV) preparation of silibinin, a constituent of the common milk thistle, Silybum marianum. The pharmacological effects of Legalon® SIL have been studied and it has a well elucidated mechanism of action in amatoxin poisoning. Legalon® SIL blocks hepatocyte uptake of amatoxin allowing the poison to be cleared more quickly from the body. Legalon® SIL has been used in the treatment of amatoxin mushroom poisoning for more than 20 years and it is currently approved for use in many European countries. It is estimated that more than 3900 patients have been treated with Legalon® SIL. Animal studies and uncontrolled clinical trials suggest that Legalon® SIL has efficacy for the prevention and treatment of amatoxin induced hepatic failure. It is well tolerated, with documented side effects of occasional flushing and less frequently, benign rashes. Legalon® SIL has been used in the USA via Emergency INDs in several cases of amatoxin poisoning over the past three years.
Treatment success using Legalon® SIL is highly correlated to its prompt initiation following the diagnosis of amatoxin mushroom poisoning. A stockpile of Legalon® SIL is now available in the USA for this Open Treatment IND allowing for same day shipping to any treating facility, thus ensuring that the drug may be started as quickly as possible. Madaus Madaus GmbH is a German pharmaceutical company specializing in the research, development, manufacturing and international marketing of plant based drugs. Founded by a physician almost 100 years ago the company’s key products are in the therapeutic areas of hepatic disease, upper respiratory disorders and genito-urinary complaints.
Rottapharm Rottapharm, the parent company of Madaus, started in 1961 as an independent research laboratory. The company has invested in innovative research, product development and global distribution of new pharmaceutical and nutraceutical products. Via its own R&D department Rottapharm has discovered and developed a rich portfolio of original molecules and drugs. With the acquisition of the German multinational Madaus Pharma, Rottapharm has become one the most important pharmaceutical companies in Italy and the company has a commercial presence in over 85 countries worldwide. Legalon® SIL Open Treatment IND Study As a result of the favorable outcomes for patients receiving Legalon® SIL under the Emergency INDs, the FDA has now sanctioned an Open Treatment IND of Legalon® SIL in the USA. Our goal is to make treatment with Legalon® SIL available to all patients with amatoxin mushroom poisoning in a rapid manner.
Any physician with a case of suspected amatoxin mushroom poisoning may have Legalon® SIL overnighted after calling a 24 hour hotline. When a physician calls the hotline (s)he will be contacted by the Principal Investigator (PI). Once the PI determines that the situation qualifies for the Legalon® SIL study, a supply of the antidote will be shipped overnight to the hospital pharmacy. Upon the completion of treatment the attending physician will submit all relevant data to the PI for follow up. IMMEDIATELY CALL THE LEGALON® SIL HOTLINE: 866-520-4412 IF YOU HAVE A SUSPECTED CASE OF AMATOXIN-MUSHROOM POISONING.
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