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U.S. Marshals Seize Drug Products Manufactured By Caraco Pharmaceutical Laboratories Ltd. FDA Acts To Prevent Repeated Drug Quality Problems
U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company"s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, M.D., director of the FDA"s Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public."
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Addictive 'Spice Gold' Causes Withdrawal Syndrome
A clinical report from Dresden supports the impression that "Spice Gold" is strongly addictive. In the current edition of Deutsches Arzteblatt International (Dtsch Arzteblatt Int 2009: 106[27]: 464-7), Ulrich S. Zimmermann, from Dresden Technical University, and his colleagues describe a young man who developed physical withdrawal symptoms after regular consumption of this designer drug, accompanied by a dependence syndrome.
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Individual Bacterial Cells Are Capable Of Quorum Sensing When Confined In Small Volumes
Infections of wounds, pneumonia, etc. in hospitals in particular are often caused by bacteria called Pseudomonas aeruginosa. Once they reach a certain density, colonies of Pseudomonas aeruginosa produce virulence factors and can enter into a slimy state, a biofilm, which prevents antibiotics from penetrating. The process of quorum sensing, which cells use to "sense" cell density, is triggered when the concentration of certain signaling compounds generated by the bacteria reaches a threshold level. A team working with Rustem F. Ismagilov at the University of Chicago has now demonstrated that the absolute number of cells is irrelevant; only the number of bacteria in a given volume plays a role. As the researchers report in the journal Angewandte Chemie, they were even able to trigger quorum-sensing processes in single cells when these were confined in extremely small volumes.
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Dialysis Patients Found To Have Unbalanced Trace Elements

Abnormal levels of trace elements may explain dialysis morbidity. A systematic review published in the open access journal BMC Medicine has shown that, compared to healthy controls, dialysis patients have significantly different blood concentrations of trace elements. Marcello Tonelli, from the University of Alberta, Canada, led a team of researchers who investigated the trace element status of dialysis patients in 128 studies. They found that levels of cadmium, chromium, copper, lead, and vanadium were higher and that levels of selenium, zinc and manganese were lower in the hemodialysis patients, compared with controls. Tonelli said, "Since both deficiency and excess of trace elements are potentially harmful yet amenable to therapy, the hypothesis that trace element status influences the risk of adverse clinical outcomes is worthy of investigation". The researchers found that data examining any possible relation between trace element status and clinical outcomes are scarce. However, they point out that the nephrology community"s experience with aluminium toxicity exemplifies the damage that uncontrolled elemental accumulation can cause, "Aluminium accumulation led to serious toxicity in dialysis patients prior to the recognition that aluminium in dialysate and oral medications was responsible. Today, such aluminium-related toxicity is extremely rare. However, the possibility that other trace elements may accumulate in patients with kidney failure and cause unrecognized chronic toxicity has received surprisingly little attention". As well as the potentially toxic accumulation of some elements, this research highlights the reduced blood levels of others, including zinc. Tonelli points out that zinc supplementation is routinely used to correct deficiency in people from the general population, significantly reducing the risk of infection and all-cause death. He said, "Our data suggest that future studies should investigate the link between zinc or selenium status and clinical outcomes in dialysis patients, in whom the risk of infection is dramatically elevated compared to people with normal kidney function". 1. Trace elements in hemodialysis patients: A systematic review and meta-analysis Marcello Tonelli, Natasha Wiebe, Brenda Hemmelgarn, Scott Klarenbach, Catherine Field, Braden Manns, Ravi Thadhani and John Gill for the Alberta Kidney Disease Network BMC Medicine (in press) http://www.biomedcentral.com/bmcmed/ Graeme Baldwin BioMed Central


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