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Category: European Union
Peligro por E.Coli La bacteria asesina

Agencias e Internet.
¿Peligro a la vista? Un fuerte brote de la cepa Escherichia coli o también llamada E. coli ha puesto en alarma a toda Europa con más de 1800 casos de contagio y unas 18 muertes.
Los científicos apuntan a que esta situación se debería al consumo de vegetales o alimentos contaminados con la referida bacteria.
Sumado a esto, la situación se torna alarmante más aún con la postura de la Organización Mundial de la Salud (OMS), al indicar que la bacteria es conocida pero jamás hubo un brote así en el mundo.
Ataca a los intestinos
Se sabe incluso que esta E. coli, por sí sola no genera ningún mal en la salud, sin embargo, la cepa que ya está originando las infecciones y muertes en el mundo posee la característica de adherirse fuertemente a las paredes de los intestinos donde bombea toxinas provocando en algunos casos diarrea sangrienta u otras severas complicaciones.
Además, la citada cepa letal sería en verdad la combinación de dos cepas, lo cual tiene como resultado una cepa mucho más dañina, según dijo a la BBC el Dr. Alfredo Torres, coordinador de la Red Latinoamericana de Investigación en Escherichia coli.
Conocida en América Latina
Refirió también que diferentes variedades de la E. coli están presentes principalmente en las regiones de América Latina, Asia y África.
Asimismo, la bacteria es considerada como una de las principales causas de infecciones gastrointestinales en niños menores de 5 años en el mundo que está en desarrollo.
Incluso se calcula que un 7% de la población infantil de las regiones antes citadas, muere a causa de las diarreas provocadas por la E.coli. En los casos de los que sobreviven, tienen graves secuelas como malnutrición y complicaciones digestivas por el resto de su vida.
Por otra parte, la Organización Mundial de la Salud (OMS) informó que la diarrea mata cada año en el mundo a 2.2 millones de personas, de los cuales 1.5 millones son niños menores de cinco años.
Lanzan advertencia
Entre las recomendaciones que se están dando en los países afectados con el brote de la E.coli, destaca la promoción de una higiene personal, dado que el contagio también puede darse de una persona a otra.
También las precauciones implican el almacenamiento de vegetales en lugares limpios, algunos especialistas hasta recomiendan evitar comer verduras crudas.
Actualmente, el país que enfrenta un grave problema con la E.coli es la Argentina, donde la variante 0157 H7 produce el síndrome umérico hemolítico (SUH), que causa insuficiencia renal y hasta la muerte.
La alarma ya está dada y según los especialistas, un descuido en esta parte de la región sería “devastador”.
Delayed FDA Removal of Painkiller Propoxyphene

Delayed FDA Removal of Painkiller Propoxyphene (Darvon, Darvocet) From U.S. Market Has Cost More Than 1,000 U.S. Lives
Statement by Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group
Note: Public Citizen petitioned the FDA in 1978 and 2006 to ban propoxyphene.
The announcement by the U.S. Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market * because of dangers previously known and acted upon, with bans announced in the UK almost six years ago, and in Europe, almost 1½ years ago * is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller. In announcing the ban in 2005, the UK stated that the efficacy of propoxyphene (sold generically and under the brand name Darvon) “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable” and that “[I]n relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose.” The FDA’s claim that this is the first evidence that the drug is dangerous at the “standard therapeutic dose” thus rings dangerously hollow.
The FDA’s deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the UK and Europe, but was for too long recklessly rejected by the FDA.
Evidence going back more than 30 years indicates that propoxyphene is not very effective, is toxic at doses not much higher than the recommend dose because a heart-toxic metabolite accumulates in the body, and is somewhat addictive. It has been linked to many thousands of U.S. deaths since 1981, a large proportion of which were likely caused by cardiac toxicity, including the interruption of electrical conduction in the heart.
Since the time of the UK announcement in January 2005 of a phased, two-year withdrawal of this drug (which was followed by an immediate steep decline in use), approximately 120 million retail prescriptions have been filled in the U.S. for propoxyphene-containing drugs. These include Darvocet, which contains propoxyphene and acetaminophen and, primarily, the generic versions of the drug.
Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced. The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being “caused” by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.
Our February 2006 petition to the FDA to ban the drug, following the UK ban announcement, did not even result in an FDA advisory committee hearing until we had sued the agency in 2008 to force them to respond to our petition. The subsequent January 2009 FDA advisory committee hearing resulted in a 14-12 vote in favour of banning propoxyphene, despite some FDA efforts to sway the committee against voting for a ban. In July 2009, several weeks after the European Medicines Agency announced its ban, the FDA denied our petition to ban the drug.
The FDA’s pitiful excuse that it needed to order a human study to find that “the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities” before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world * which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.
In a study on dogs published 31 years ago, researchers at Lilly, the discoverer of propoxyphene, stated that “cardiac conduction depression may be a factor in some of the [human] cardiac toxicities associated with propoxyphene overdose.” This study examined the same kind of function measured in the human study now being put forth by the FDA as a justification for belatedly banning propoxyphene.
We will ask for and support a congressional investigation into whom in the FDA, specifically in the Centre for Drug Evaluation and Research, was responsible for the loss of so many lives in this country. It is clear that long before today, many drug safety experts in the Office of Surveillance and Epidemiology had decided the drug should be removed from the market.
Note: For a chronology of events related to Darvon and Darvocet, go to
http://www.citizen.org/documents/chronologyofinactions.pdf
Public Citizen is a national, non-profit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.
Regards
Sidney M. Wolfe MD
Director, Health Research Group at Public Citizen
1600 20th St. NW
Washington, DC 20009
Phone: +1 202 588-7735
Swolfe@citizen.org
www.worstpills.org
www.citizen.org/hrg
