http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266468.htm

Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects
[Posted 08/03/2011]

AUDIENCE: OBGYN, Pharmacy, Infectious Disease

ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. This risk does not appear to be associated with a single, low dose of fluconazole 150mg to treat vaginal yeast infection (candidiasis). Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.

BACKGROUND: Diflucan is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before bone marrow transplant. Diflucan is also used to treat meningitis caused by a certain type of fungus. Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.

RECOMMENDATION: Healthcare professionals should counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. Patients should notify their healthcare professionals if they are or become pregnant while taking fluconazole. If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
Download form2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm266611.htm

FDA NEWS RELEASE
For Immediate Release: August 3, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves the first specific treatment for scorpion stings
The U.S. Food and Drug Administration today approved Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the United States.

Venomous scorpions in the U.S. are mostly found in Arizona. Severe stings occur most frequently in infants and children, and can cause shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, trouble walking, and other uncoordinated muscle movements. Untreated cases can be fatal.

“This product provides a new treatment for children and adults and is designed specifically for scorpion stings,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Scorpion stings can be life-threatening, especially in infants and children.”

Anascorp, Centruroides (Scorpion) Immune F(ab’)2 (Equine) Injection, is made from the plasma of  horses immunized with scorpion venom. Anascorp may cause early or delayed allergic reactions in people sensitive to horse proteins. The manufacturing process for Anascorp includes steps to decrease the chance of allergic reactions and to reduce the risk of transmission of viruses that may be present in the plasma.

The effectiveness of Anascorp was based on results from a randomized, double-blind, placebo-controlled trial of 15 children with neurological signs of scorpion stings. These signs resolved within four hours of treatment in the eight subjects who received Anascorp, but in only one of the seven participants who received the placebo. The most common side effects were vomiting, fever, rash, nausea, itchiness, headache, runny nose, and muscle pain. In total, safety and efficacy data was collected from 1,534 patients in both open-label and blinded studies.

Anascorp was designated as an Orphan drug by FDA and received priority review. It is licensed to Rare Disease Therapeutics Inc., Franklin, TN, distributed by Accredo Health Group Inc., Memphis, TN, and manufactured by Instituto Bioclon, S.A. de C.V., of Tlalpan, Mexico, D.F.

For more information:

Product Approval1

Consumer Update2

Orphan Drugs3

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6031a2.htm?s_cid=mm6031a2_e&source=govdelivery

Human Rabies from Exposure to a Vampire Bat in Mexico — Louisiana, 2010

Weekly

August 12, 2011 / 60(31);1050-1052 

In August 2010, CDC confirmed a case of rabies in a migrant farm worker, aged 19 years, hospitalized in Louisiana with encephalitis. The man developed acute neurologic symptoms at the end of July, shortly after arriving in the United States from Michoacán, Mexico. Despite supportive care, his condition deteriorated, and he died on August 21. Antemortem diagnostic testing confirmed the diagnosis of rabies, and samples collected at autopsy were positive for a vampire bat rabies virus variant. The patient’s mother reported that he had been bitten by a bat in July in Mexico but had not sought medical care. Postexposure prophylaxis (PEP) was offered to 27 of the patient’s contacts in Louisiana and to 68 health-care workers involved in his care. Although bats have become the primary source of human rabies in the United States, this is the first reported death from a vampire bat rabies virus variant in the United States. Clinicians caring for patients with acute progressive encephalitis should consider rabies in the differential diagnosis and implement early infection control measures.

Case Report

On July 29, 2010, a previously healthy male, aged 19 years, from Michoacán, Mexico, arrived at a sugarcane plantation in Louisiana. After 1 day of work in the fields, the patient sought medical attention on July 30 for generalized fatigue, left shoulder pain, and left hand numbness attributed to overexertion. The patient’s symptoms continued, and he was evaluated at a local clinic and transferred to a referral hospital in New Orleans for further evaluation and management on August 3.

Physical examination at the referral hospital revealed hyperesthesia of the left shoulder, weakness of the left hand, generalized areflexia, and drooping of the left upper eyelid. A lumbar puncture produced cerebrospinal fluid (CSF) with a mildly elevated white blood cell count of 8 cells/mm3 (normal: 0–5 cells/mm3) with 67% lymphocytes and 12% neutrophils, a normal glucose, and no organisms on staining. The patient was admitted to the intensive-care unit for suspected Miller-Fisher variant of acute inflammatory demyelinating polyneuropathy (also referred to as Guillain-Barré syndrome), with viral encephalitis and early meningitis among the alternative diagnoses considered.

The next day, the patient developed a fever of 101.1°F (38.4°C) and signs of respiratory distress that prompted elective intubation. Computerized tomography and magnetic resonance imaging of the head revealed only a developing sinusitis. During the next several days, the patient became gradually less responsive to external stimuli, developed fixed and dilated pupils, and began having episodes of bradycardia and hypothermia. Further evaluation included a repeat lumbar puncture revealing an elevation of the white blood cell count to 87 cells/mm3 with 97% lymphocytes and an elevated protein of 233 mg/dL (normal: 15–45 mg/dL). An electroencephalogram was consistent with encephalitis. Bacterial, viral, and fungal cultures of blood and CSF were negative. Additionally, laboratory tests for human immunodeficiency virus, syphilis, herpes simplex virus, arboviruses, Lyme disease, and autoimmune neuropathies all were negative.

Although no history of animal exposures was known at that time, a diagnosis of rabies was suspected based on the clinical history and available data. The Louisiana Office of Public Health was informed of the potential case of rabies, and infection control precautions were instituted on August 13, the 11th hospital day. On August 20, rabies virus–specific immunoglobulin G and immunoglobulin M detected in the patient’s CSF and serum confirmed the diagnosis of rabies. After discussion with the family about the patient’s prognosis and a subsequent electroencephalogram showing severe cortical impairment, the patient was extubated on August 21 in accordance with the family’s wishes and died shortly thereafter. Rabies virus antigen was detected in postmortem brain tissues collected on August 22, and antigenic typing determined the variant to be a vampire bat rabies virus variant, which was subsequently confirmed by nucleic acid amplification and sequencing.

Public Health Investigation

Public health authorities in Louisiana and Mexico interviewed the patient’s family members, friends, and coworkers to identify potential rabies virus exposures. The patient’s mother stated that the patient was bitten by a vampire bat on the heel of his left foot while he was sleeping. The bite occurred on July 15 in his home state of Michoacán, Mexico, 10 days before his departure for the United States. He did not seek medical attention for this bite and had no history of vaccination against rabies. No other exposures to bats, dogs, or other mammals were identified.

Mexican health authorities identified five close contacts of the patient in his home state of Michoacán but determined that none of these contacts had exposures requiring PEP. However, animals in this area were frequently observed with bites from vampire bats, and officials conducted a vaccination campaign of cats and dogs in the local community. In addition, officials attempted to reduce the local vampire bat population by capturing 120 vampire bats and applying a warfarin-containing jelly to their backs. After being released, the bats and their roostmates ingest the anticoagulant through communal grooming. Diagnostic rabies testing performed on one of the captured bats was negative.

The Louisiana Office of Public Health with the assistance of hospital infection control staff interviewed clinic, hospital, and prehospital health-care providers to determine risks for exposure and provide PEP recommendations. Additionally, migrant workers who either accompanied the patient from Mexico or lived and worked with him in Louisiana were interviewed, and exposed contacts were offered PEP. In total, 95 of 204 (46.5%) patient contacts received PEP. Of these, 27 were coworkers who reported sharing a drinking vessel with the patient, and 68 were health-care workers with various exposures. To date, no known human contacts of this patient have developed rabies.

Editorial Note

This case represents the first report of human rabies in the United States associated with a vampire bat rabies virus variant and highlights the growing importance of bats in public health. Bat rabies virus variants have been associated with the majority of indigenously acquired human rabies cases in the United States for approximately 2 decades. Similarly, vampire bats have become the leading cause of human rabies in Latin America during the last decade (1). This further highlights the importance of a global perspective for human rabies prevention and the changing epizootiology of rabies. Since 2000, eight (25%) of the 32 human rabies cases reported in the United States (including the case described in this report) were acquired from exposures abroad. Of these, two cases originated in Mexico and were the only imported cases not associated with a canine rabies virus variant; this finding might reflect improved control of canine rabies in Mexico. International coordination among public health officials remains a crucial component in investigating cases of infectious diseases and improving prevention and control efforts.

The incubation period of 15 days observed in this report is shorter than the median of 85 days seen in other cases of human rabies reported in the United States (2). The incubation period for rabies associated with vampire bats might be shorter than that of other rabies virus variants, as suggested by one case series reporting an average incubation period of 22 days (3). Alternatively, the patient might have experienced an earlier exposure that went unrecognized or unreported. A second unidentified exposure resulting in infection also would explain the upper extremity symptoms observed given that symptoms often occur at the site of viral entry.

Health-care providers should recognize a history of travel to or immigration from a country with enzootic rabies as a risk factor and consider rabies in the differential of any case of acute progressive encephalitis. International travelers to areas with enzootic canine rabies should be counseled about the risk for exposure to rabies virus, educated in animal bite prevention techniques, including not touching or feeding any animals, and instructed to seek medical evaluation if an exposure to a suspected rabid animal occurs (4). Preexposure vaccination may be recommended if traveling to areas with limited access to appropriate medical care (4,5). Appropriate infection control practices can decrease the risk for virus transmission in suspected or confirmed cases of human rabies. In such cases, caregivers should wear gowns, goggles, masks, and gloves, particularly during intubation and suctioning (5). If rabies is confirmed, a standardized risk assessment of patient contacts with strict application of the exposure definitions detailed by the Advisory Committee on Immunization Practices (ACIP) in combination with educational outreach might minimize unnecessary PEP in those who do not meet criteria (5). Active participation of public health officials and close supervision of hospital infection control staff during this process are recommended.

Although vampire bats currently are found only in Latin America, research suggests that the range of these bats might be expanding as a result of changes in climate (6). Expansion of vampire bats into the United States likely would lead to increased bat exposures to both humans and animals (including domestic livestock and wildlife species) and substantially alter rabies virus dynamics and ecology in the southern United States. In addition to rabies and other lyssaviruses, accumulating evidence implicates bats as reservoirs and potential vectors of a number of emerging infectious diseases (7). These discoveries raise further questions about the health risks to human populations with direct or indirect contact with bats, particularly given the high disease severity and fatality rates associated with these zoonoses. Further research should be directed toward better defining the nature and magnitude of the risks to human health posed by bats.

To mitigate the known risk for rabies, public education should increase awareness of the risk for rabies transmitted from bats and encourage avoidance of contact with bats and wildlife in general. Although commonly practiced, the elimination of vampire bats to prevent human or animal rabies remains controversial. Any potential human exposure to a bat should be investigated thoroughly to determine whether PEP is indicated, and bats involved in exposures should be safely collected and submitted for rabies testing when possible (5).

Acknowledgments

Staff members of the Louisiana Office of Public Health. Staff members of Health Svcs of Mexico City and Michoacán, Mexico. Jesse D. Blanton, MPH, Richard Franka, DVM, PhD, Michael Niezgoda, MS, Lillian A. Orciari, MS, Sergio Recuenco, MD, Andres Velasco-Villa, PhD, and Pamela A. Yager, Div of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, CDC.

References

1. Schneider MC, Romijn PC, Uieda W, et al. Rabies transmitted by vampire bats to humans: an emerging zoonotic disease in Latin America? Rev Panam Salud Publica 2009;25:260–9.
2. Noah DL, Drenzek CL, Smith JS, et al. Epidemiology of human rabies in the United States, 1980 to 1996. Ann Intern Med 1998;128:922–30.
3. Lopez A, Miranda P, Tejada E, Fishbein DB. Outbreak of human rabies in the Peruvian jungle. Lancet 1992;339:408–11.
4. Blanton JD, Rupprecht CE. Travel vaccination for rabies. Expert Rev Vaccines 2008;7:613–20.
5. CDC. Human rabies prevention—United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR 2008;57(No. RR-3).
6. Mistry S, Moreno A. Modeling changes in vampire bat distributions in response to climate change: implications for rabies in North America. Presented at the 19th International Conference on Rabies in the Americas, Atlanta, GA, September 28–October 3, 2008.
7. Calisher CH, Childs JE, Field HE, Holmes KV, Schountz T. Bats: important reservoir hosts of emerging viruses. Clin Microbiol Rev 2006;19:531–45.

http://www.cdc.gov/salmonella/heidelberg/index.html

Investigation Update: Multistate Outbreak of Human Salmonella Heidelberg Infections Linked to Ground Turkey

• A total of 78 persons infected with the outbreak strain of Salmonella Heidelberg have been reported from 26 states.
• Collaborative investigative efforts of state, local, and federal public health and regulatory agencies indicate that eating ground turkey is the likely source of this outbreak.
• On August 3, 2011, an Arkansas firm recalled ground turkey products due to possible Salmonella contamination.
• Contaminated ground turkey is being recalled from grocery stores but may still be in consumers’ homes.
• Consumers should check their homes for recalled ground turkey products  [PDF - 1.24 MB] and not eat them; restaurant and food service operators should not serve them.
• The outbreak strain of Salmonella Heidelberg is resistant to several commonly prescribed antibiotics; this antibiotic resistance may increase the risk of hospitalization or possible treatment failure in infected individuals.
• Go to August 4, 2011 for a full report.

The Cargill Recall List:  http://www.cargill.com/wcm/groups/public/@ccom/documents/document/na3047772.pdf

http://www.ems1.com/health-and-wellness/articles/1091143-Dr-Max-Harry-Weil-CPR-pioneer-dies-at-84/

EMS1

Dr. Max Harry Weil dead at 84

http://archpedi.ama-assn.org/cgi/content/abstract/165/8/749

Safety of Trivalent Inactivated Influenza Vaccine in Children Aged 24 to 59 Months in the Vaccine Safety Datalink

Jason M. Glanz, PhD; Sophia R. Newcomer, MPH; Simon J. Hambidge, MD, PhD; Matthew F. Daley, MD; Komal J. Narwaney, MD, MPH; Stan Xu, PhD; Grace M. Lee, MD, MPH; James Baggs, PhD; Nicola P. Klein, MD, PhD; James D. Nordin, MD, MPH; Allison L. Naleway, PhD; Edward A. Belongia, MD; Eric S. Weintraub, MPH

Arch Pediatr Adolesc Med. 2011;165(8):749-755. doi:10.1001/archpediatrics.2011.112

Trivalent inactivated influenza vaccine (TIV) in children aged 24 to 59 months and to evaluate

The risk of medically attended events (MAEs)

There was no evidence of serious MAEs following vaccination with TIV among children aged 24 to 59 months. Further studies are warranted to evaluate the risk of MAEs in children with multiple lifetime TIV doses.