Archive for July, 2007

Botulism Cans Still in Stores

Intro:  We all have read about the cans of botulism chili.  Major recalls have gone out and spot-checks reveal that these cans are still in stores.  This is just a reminder to you about not only carefully examining a patient with neuro complaints, but also people coming in with GI complaints.  Oftentimes, foodborne botulism begins with abdominal pain, nausea, vomiting, and diarrhea.  The neuro manifestations occur later.

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AP, 7/27/07:  Stores nationwide are continuing to sell recalled canned chili, stew, hash and other foods potentially contaminated with poisonous bacteria even after repeated warnings the products could kill. Thousands of cans are being removed from store shelves as quickly as investigators find them, more than a week after Castleberry’s Food Co. began recalling more than 90 potentially contaminated products over fears of botulism contamination.

The recall now covers two years’ production at the company’s Augusta, Ga., plant - a tally that spirals into the tens of millions of cans.

Spot checks by the Food and Drug Administration and state officials continue to turn up recalled products for sale in convenience stores, gas stations and family run groceries, from Florida to Alaska. The FDA alone has found them in roughly 250 of the more than 3,700 stores visited in nationwide checks, according to figures the agency provided to The Associated Press.

In states like North Carolina, more than one in three stores checked by state officials in recent days were still offering recalled products for sale. Officials there pulled 5,500 cans and pledged to keep searching.

“We’re not going to quit. These numbers are too high,” said Joe Reardon, who oversees food protection for the state Department of Agriculture and Consumer Services.

Four people have been sickened and hospitalized because of the contaminated food, according to the Centers for Disease Control and Prevention. Officials fear the tally will grow.

“Frankly, the fact we have had only four illnesses in this situation has people saying, ‘Well, what is the big deal?’ The deal is this is something that can land you in the ICU, not being able to breathe, for weeks,” said Dr. David Acheson, the FDA’s lead food safety expert.

FDA investigators believe Castleberry’s failed to properly cook some or all the products, allowing the Clostridium botulinum bacteria to survive the canning process. In the oxygen-free and moist environment of the sealed cans, the bacteria thrive and produce a toxin that causes botulism , a muscle-paralyzing disease.

“The longer this stuff stays in the can, the worse it gets,” Acheson said.

The bacteria also produce gases that can cause contaminated cans to swell and burst. Already, cans being held in a company warehouse have begun to break open. Health officials say the extremely potent toxin can infect people if it is inhaled, swallowed or absorbed through the eye or breaks in the skin.

Health experts consider botulism a severe health threat but worry that word of the recall has not reached all consumers or retailers, especially mom-and-pop operations.

“It has been a problem getting the message out. We’re having a problem reaching the smaller stores,” said Lynae Granzow, an epidemiologist with the Indiana Department of Health.

In Massachusetts, health inspectors found recalled products in fewer than 50 small stores, mostly in the Boston area, state Department of Public Health spokeswoman Donna Rheaume said. Spot checks in Alaska, Florida, Kentucky, Montana, New York, Indiana and elsewhere also have found them on shelves.

Castleberry’s has hired a company to collect the recalled products from stores. It has posted a complete list of the recalled products, including some dog foods, on its Web site.

People who have any of the recalled products at home should double-bag and throw them away, the FDA recommends.

Castleberry’s is owned by Bumble Bee Seafoods LLC, based in San Diego.

Consumers with questions about the recall may contact Castleberry’s at 1-888-203-8446.

Single Dose of Dexamethasone May Not Improve Outcomes of Infant Bronchiolitis

July 25, 2007 — A single dose of dexamethasone, 1 mg/kg, does not significantly change hospital admission rate, respiratory status after 4 hours, or later outcomes of infants with acute to severe bronchiolitis, according to the results of a randomized double-blind study published in the July 26 issue of the New England Journal of Medicine.

“Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood,” write Howard M. Corneli, MD, from the University of Utah in Salt Lake City, and colleagues from the Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN). “Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited.”

At 20 emergency departments during the months of November through April for a 3-year period, 600 children were enrolled with a first episode of wheezing diagnosed as moderate to severe bronchiolitis, based on a Respiratory Distress Assessment Instrument (RDAI) score of 6 or greater. Age range was 2 to 12 months. Patients were randomized to receive a single dose of oral dexamethasone (1 mg/kg of body weight) or placebo. The main endpoint was hospital admission after 4 hours of observation in the emergency department; the secondary endpoint was the Respiratory Assessment Change Score (RACS); and subsequent outcome measures included length of hospital stay, later medical visits or admissions, and adverse events.

Both groups had similar clinical characteristics at baseline and had improved respiratory status during observation. In the dexamethasone group, the admission rate was 39.7% vs 41.0% in the placebo group (absolute difference, -1.3%; 95% confidence interval, -9.2 to 6.5). Mean 4-hour RACS was -5.3 for dexamethasone and -4.8 for placebo (absolute difference, -0.5; 95% confidence interval, -1.3 to 0.3). These findings were not significantly changed by multivariate adjustment, and later outcomes did not differ significantly between groups.

“In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes,” the authors write. “We recommend evaluation of other treatments and preventive strategies for bronchiolitis.”

Study limitations were exclusion of children with possible early asthma; exclusion of older children and children with recurrent wheezing, who might have a different response to dexamethasone; and use of only a single oral dose of dexamethasone (1 mg/kg).

The Maternal and Child Health Research program and the Emergency Medical Services for Children program of the Maternal and Child Health Bureau, Health Resources and Services Administration, supported this study. Two of the authors have disclosed various financial relationships with Sepracor, St. Jude Medical, Tyco Health Care, Ucyclyd Pharma, and/or GlaxoSmithKline.

In an accompanying editorial, Caroline Breese Hall, MD, from the University of Rochester School of Medicine and Dentistry in Rochester, New York, notes that potential study limitations “should not diminish recognition of the soundness of the study’s results and their clinical pertinence.”

“Despite the value of this study, the long history of therapies and recommendations attending bronchiolitis suggest that the study’s results will not appreciably change the nature of the care provided by the primary physician faced with a young, distressed infant and anxious parents,” Dr. Hall writes. “Withholding therapy is much more difficult than giving it.”

Dr. Hall has disclosed no relevant financial relationships.

N Engl J Med. 2007;357:331-339, 402-404.

Zofran in Kids with Gastroenteritis

Aliment Pharmacol Ther.  2007; 25(4):393-400 (ISSN: 0269-2813)

Szajewska H ; Gieruszczak-Bia?ek D ; Dylag M
The Second Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland. hania@ipgate.pl

BACKGROUND: Vomiting is a common sympton in children with gastroenteritis, but its treatment remains controversial. AIM: To investigate potential beneficial effects of ondansetron, compared with placebo or no intervention, in treating vomiting during acute gastroenteritis in children. METHODS: The following electronic databases were searched through August 2006: MEDLINE, EMBASE, CINAHL and The Cochrane Library; additional references were obtained from reviewed articles. Only randomized-controlled trials (RCTs) were included. RESULTS: Four RCTs involving 490 patients with vomiting during acute gastroenteritis were included. Combined data from three RCTs (n = 466) showed that ondansetron compared with the control significantly increased the chance for vomiting cessation soon after drug administration [relative risk (RR): 1.3, 95% confidence interval (CI): 1.2-1.5, number needed to treat (NNT): 5, 95% CI: 4-8], but this effect was not observed at 24 h (three RCTs, n = 144, RR 1.2, 95% CI: 0.9-1.7). Ondansetron significantly reduced the risk of intravenous rehydration (two RCTs, n = 359, RR 0.4, 95% CI: 0.3-0.7, NNT 7, 95% CI: 5-14). Outcome measures not significantly different after ondansetron treatment were the need for hospitalization and return emergency department visits. CONCLUSIONS: Despite some clinical benefits, there is insufficient evidence to recommend the routine use of ondansetron for vomiting during acute gastroenteritis in children.

Succinylcholine versus Rocuronium

Int J Clin Pract.  2006; 60(12):1638-46 (ISSN: 1368-5031)

Karcioglu O; Arnold J; Topacoglu H; Ozucelik DN; Kiran S; Sonmez N
Department of Emergency Medicine, Dokuz Eylul University School of Medicine, Izmir, Turkey. ozgur.karcioglu@deu.edu.tr

This meta-analysis was undertaken to compare the effects of succinylcholine (SCH) and rocuronium (RCR) on endotracheal intubation (ETI) conditions. Eligible randomised controlled trials (RCTs) were identified via medline and a manual search of references. The frequencies of excellent and unacceptable ETI conditions in subjects receiving SCH 1.0-1.5 mg/kg and RCR 0.6-1.2 mg/kg were determined using standard statistical methods. Inclusion criteria were met by 16 RCTs, representing 1362 subjects. SCH was associated with a 17.7% increase (95% CI = 13-22) in the frequency of excellent ETI conditions and a 5.1% decrease (95% CI = -7.3 to -2.9) in the frequency of unacceptable ETI conditions, when compared with RCR. In the subgroup undergoing true rapid sequence intubation, SCH was associated with a 19.1% increase (95% CI = 13.7-24.5) in the frequency of excellent ETI conditions. SCH appears to be superior to RCR in creating excellent ETI conditions and avoiding unacceptable ETI conditions.