FDA warns of potential contamination in multiple brands of drugs, dietary supplements
The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 11, 2017 Category: American Health Source Type: news
FDA Warns Against Use of Any Liquid Product From PharmaTech FDA Warns Against Use of Any Liquid Product From PharmaTech
Lab tests have found Burkholderia cepacia contamination in PharmaTech ' s oral liquid docusate products, which has been linked to recent patient infections.News Alerts (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - August 9, 2017 Category: Intensive Care Tags: Infectious Diseases News Alert Source Type: news
Rugby Laboratories Issues Voluntary Nationwide Recall of Diocto Liquid and Diocto Syrup Manufactured By PharmaTech, LLC Due to Possible Product Contamination
Rugby ® Laboratories of Livonia, MI is voluntarily recalling all lots within the expiry of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC of Davie, FL due to a risk of product contamination with Burkholderia cepacia. If a product contains B. cepacia, its use c ould result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 3, 2017 Category: Food Science Source Type: news
Synspira ’s therapy could boost antibiotics against drug-resistant bacteria in CF patients
Privately-held Synspira touted a study today of its inhaled glycopolymer-based therapeutic with antibiotics as a potential treatment for pulmonary infection caused by the Burkholderia cepacia complex in patients with cystic fibrosis.
The study was published in PLOS One. Synspira’s lead polycationic glycopolymer, SNSP113, was studied in combination with tobramycin and meropenem. These antibiotics, as well as ceftazidime, are often used to treat Bcc infections in patients with cystic fibrosis. However, Synspira said the microbial agents have demonstrated limited efficacy in the past.
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Source: Mass Device - July 12, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Research & Development Respiratory synspira Source Type: news
Symbiotic bacteria: From hitchhiker to beetle bodyguard
Bacterial symbionts transition between plant pathogenicity and insect defensive mutualism, a new report demonstrates. The bacterium Burkholderia gladioli lives in specific organs of a plant-feeding beetle and defends the insect ' s eggs from detrimental fungi by producing antibiotics. However, when transferred to a plant, the bacterium can spread throughout the tissues and negatively affect the plant. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - April 28, 2017 Category: Science Source Type: news
Symbiotic bacteria: From hitchhiker to beetle bodyguard
(Johannes Gutenberg Universitaet Mainz) An international team of researchers have discovered a remarkable microbe with a Jekyll and Hyde character. The bacterium Burkholderia gladioli lives in specific organs of a plant-feeding beetle and defends the insect's eggs from detrimental fungi by producing antibiotics. However, when transferred to a plant, the bacterium can spread throughout the tissues and negatively affect the plant. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - April 28, 2017 Category: Biology Source Type: news
Master switch turns on silent biosynthetic gene clusters
Scientists have discovered a global regulator in the model bacterium Burkholderia thailandensis that ' switches on ' many silent clusters at once, unleashing their full ability to make possible drug candidate natural products. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - April 13, 2017 Category: Science Source Type: news
Scientists discover master switch to turn on silent biosynthetic gene clusters
(Princeton University) Scientists at Princeton University have discovered a global regulator in the model bacterium Burkholderia thailandensis that 'switches on' many silent clusters at once, unleashing their full ability to make possible drug candidate natural products. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 13, 2017 Category: Global & Universal Source Type: news
From Genome Research: Pathogen demonstrates genome flexibility in cystic fibrosis
(Cold Spring Harbor Laboratory) Chronic lung infections can be devastating for patients with cystic fibrosis (CF), and infection by Burkholderia cenocepacia, one of the most common species found in cystic fibrosis patients, is often antibiotic resistant. In a study published today in Genome Research, scientists sequenced and phenotyped multiple B. cenocepacia isolates from 16 CF patients. They found extensive variation among isolates during chronic lung infection as well as changes in clinically relevant bacterial phenotypes. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - March 21, 2017 Category: Infectious Diseases Source Type: news
Infectious outbreak in critically ill children leads to recall of contaminated medication
Infection prevention and control experts halted a 24-patient outbreak of Burkholderia cepacia in critically ill children after identifying docusate, a liquid stool softener, as the underlying source of the bacteria. Details of the six-month investigation led to a national recall of all liquid products manufactured by PharmTech. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - February 9, 2017 Category: Science Source Type: news
Infectious outbreak in critically ill children leads to recall of contaminated medication
(Society for Healthcare Epidemiology of America) Infection prevention and control experts at Texas Children's Hospital halted a 24-patient outbreak of Burkholderia cepacia in critically ill children after identifying docusate, a liquid stool softener, as the underlying source of the bacteria. Details of the six-month investigation, published online in Infection Control& Hospital Epidemiology, the journal for the Society for Healthcare Epidemiology of America, led to a national recall of all liquid products manufactured by PharmTech. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - February 9, 2017 Category: Infectious Diseases Source Type: news
Class I Medical Device Recall: Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections
Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 3, 2017 Category: Medical Equipment Source Type: news
Stryker ’ s Sage Products invests $3.4m to expand HQ
Stryker (NYSE:SYK) subsidiary Sage Products purchased 27 acres of land in Cary, Ill. for $3.4 million, looking to expand its headquarters in the area, according to a Daily Herald report.
Sage makes products for oral care, skin preparation & protection, patient cleaning & hygiene, turning & positioning and heel care.
The planned expansion includes an 810,000 square foot addition to the facilities, and is slated to add an additional 350 jobs by 2021, according to the report.
Stryker closed its $2.7 billion acquisition of Sage Products in April. The deal for Sage Products, which makes a line of disposable de...
Source: Mass Device - December 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Sage Products Stryker Source Type: news
An Unusual case of Burkholderia dolosa Infection in a Cystic Fibrosis Patient but Not His Sister
Irreversible decline in lung function is one of the key contributors to mortality and morbidity in the cystic fibrosis (CF) population [1]. One key determinant of lung health is recurrent respiratory infections with opportunistic pathogens. Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Haemophilus influenzae, non-tuberculous mycobacteria, Staphylococcus aureus, Aspergillus fumigatus, and Burkholderia cepacia complex (BCC) are common opportunistic agents of infections or chronic pulmonary colonizers in the CF population [1]. (Source: Clinical Microbiology Newsletter)
Source: Clinical Microbiology Newsletter - November 19, 2016 Category: Microbiology Authors: Grace Y. Lam, Josette Salgado, Jamil Kanji, James E.A. Zlosnik, Neil E. Brown, Winnie M. Leung Tags: Case Report Source Type: news
In South Jersey, 13 sick with bacterial infection linked to contaminated syringes
Pre-filled syringes produced by a Texas-based medical device manufacturer are linked to 13 new cases of a bacterial infection in New Jersey, where several dozen people have already been affected.
The 13 new cases, 10 in Atlantic County and three in Ocean County, come five weeks after Halton City, Texas-based Nurse Assist voluntarily recalled all of its I.V. flush syringes "due to a potential link to Burkholderia cepacia bloodstream infections with the product," according to the FDA.
The v oluntary… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - November 14, 2016 Category: Pharmaceuticals Source Type: news
