Navigation Links
Highly-Concentrated Botulinum Preparation Can Result in Severe Illness

An examination of 4 cases of botulism following cosmetic injections to the face indicates that the adults received a highly concentrated, //unlicensed preparation that resulted in toxin levels up to 40 times the estimated human lethal dose, according to a report.

Botulism is a rare paralytic illness caused by the toxins of the spore-forming bacterium Clostridium botulinum and toxin-producing strains of Clostridium baratii and Clostridium butyricum. Botulism, left untreated, may result in respiratory failure and death, according to background information in the article. Two botulinum toxin preparations are licensed in the United States by the U.S. Food and Drug Administration for clinical use, BOTOX (crystalline toxin type A); and Myobloc/Neurobloc (toxin type B). Although botulinum toxin A is available by prescription for cosmetic and therapeutic use, no cases of botulism with detectable serum toxin have previously been attributed to cosmetic or therapeutic botulinum toxin injections. On November 27, 2004, four suspected botulism case-patients with a link to cosmetic botulinum toxin injections were reported to the Centers for Disease Control and Prevention.

Daniel S. Chertow, M.D., M.P.H., of the CDC, Atlanta, and colleagues investigated various aspects of the four suspected cases of botulism. They found that clinical characteristics of the four case-patients were consistent with those of naturally occurring botulism. All case-patients had been injected with a highly concentrated, unlicensed preparation of botulinum toxin A, intended for laboratory research, labeled accordingly, and not licensed or intended for human use.

Clinic staff had diluted a 100-μg vial of pure neurotoxin with diluent and drew up the resulting solution into syringes for clinical use. The physician working at the clinic administered 4 case-patients (including himself) 4 to 6 injections of this toxin solution in the facial area. All the patients eventually rep orted symptoms of progressive weakness and cranial neuropathies (abnormality of the nerves that control a number of functions, including movement of the facial muscles and swallowing), with two patients experiencing shortness of breath.

The researchers report the patients may have received doses 2,857 times the estimated human lethal dose by injection. Pretreatment serum toxin levels in 3 of the 4 case-patients were equivalent to 21 to 43 times the estimated human lethal dose; pretreatment serum from the fourth epidemiologically linked case-patient was not available. A 100-μg vial of toxin taken from the same manufacturer's lot as toxin administered to the case-patients contained a toxin amount sufficient to kill approximately 14,286 adults by injection if disseminated evenly.

"Botulism is a potentially fatal disease, which invariably presents with acute bilateral cranial neuropathies, regardless of exposure mechanism. Early recognition of botulism, treatment in an intensive care setting, provision of mechanical ventilation when indicated, and rapid administration of antitoxin (optimally within 12 hours of presentation) have been associated with improved clinical outcome. Suspected cases of botulism should be reported immediately to local health authorities to facilitate rapid epidemiological investigation, provision of antitoxin when indicated, and prevention of further cases," the researchers write.

"Physicians and patients must be aware of the hazards associated with illegitimate use of unlicensed botulinum toxin products. Only licensed products should be used clinically. Entities inappropriately marketing, selling, or using unlicensed botulinum toxin products should be sought and subjected to full criminal and civil penalties. The Code of Federal Regulations should be modified to reduce the weight threshold of individual shipments subject to regulation and should require researchers to provide legal documentation of credential s and adequate laboratory facilities prior to shipment of toxin," the authors conclude.


Related medicine news :

1. Appearance Of Facial Scars Improved By Botulinum Toxin
2. Uses for Botulinum Toxin — A Miracle Poison — Continue to Grw
3. Child Friendly Zidovudine Preparation for treating HIV infection Approved By The FDA
4. Resident Physicians Need More Preparations To Treat Patients From Different Cultures
5. Chinese Health Officials To Discuss Preparation Of Bird Flu
6. Preparation for Culling Begin at Belghat, Rajangaon and Dhaamnia
7. Brain Activity Patterns Linked To Mental Preparations
8. Intensive Training and Tool Kit, Indicates Adequate Preparation To Combat AIDS.
9. Herbal Preparation Effective For Treating Short Term Low-Back Pain
10. EU Countries Pushed To Make All the Preparation to Handle the Bird Flu Pandemic
11. Health Workers Need Better Preparation for Developing World
Post Your Comments:

(Date:11/27/2015)... ... November 27, 2015 , ... ... 27th edition of USA Today in Atlanta, Dallas, New York, Minneapolis, South Florida, ... The digital component is distributed nationally, through a vast social media strategy and ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television ... an interesting show that delves into an array of issues that are presently affecting ... benefit from open dialogue, this show is changing the subjects consumers focus on, one ...
(Date:11/27/2015)... Santa Rosa, CA (PRWEB) , ... November 27, 2015 , ... ... Northern California Medical Associates, Inc. and Dr. Tucker Bierbaum with Emergency Medicine ... dinner meeting. They observed that both STEMI and Sepsis conditions present in similar ways ...
(Date:11/26/2015)... Toronto, ON and Cambridge, ON (PRWEB) , ... ... ... announced today the availability of a real-time eReferral system for diagnostic imaging in ... CTs, ultrasounds, X-rays, mammography, BMD and Nuclear Medicine tests directly from their electronic ...
(Date:11/26/2015)... Mass. (PRWEB) , ... November 26, 2015 , ... ... thorough second medical opinion process, participated in the 61st annual Employee Benefits Conference. ... Plans and took place Sunday, November 8th through Wednesday, November 11th, 2015. The ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "Radioimmunoassay Market ... User (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic ... - Global Forecast to 2020" report ... ) has announced the addition of the ...
(Date:11/25/2015)...  Amgen (NASDAQ: AMGN ) today announced the ... the United States (U.S.) Food and ... to Humira ® (adalimumab). Amgen believes this submission ... FDA and represents Amgen,s first BLA submission using the ... M.D., executive vice president of Research and Development at ...
(Date:11/25/2015)... -- On Tuesday, November 24, 2015, the jury ... Medical Technology, Inc. for product liability and misrepresentation ... device, awarded $11 million in favor of Plaintiff ... three days of deliberations, the jury found that ... and unreasonably dangerous, and that Wright Medical made ...
Breaking Medicine Technology: