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Tuesday, July 29 2014 @ 12:37 AM EDT

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FDA warns drugmakers of tainted additive

Healthcare By Sue Mueller for foodconsumer.org - The Food and Drug Administration on May 4 issued an advisory to warn drugmakers, suppliers and health professionals that a counterfeit additive may be illegally used to replace or contaminate more expensive glycerin, a sweet syrup used in over-the-counter medicine like cough medications, fever medication and injectable drugs. The FDA suggests, but not requires that drug manufacturers test glycerin for possible contamination of diethylene glycol or DEG, a known poison that is used in antifreeze and as a solvent. No evidence indicates that glycerin used in the US has been tainted with the poisonous industrial solvent, the FDA says. But caution needs to be excised to ensure glycerin used in the country is free of DEG. The warning was issued as cases of death associated with use of tainted glycerin have been reported to the FDA since last October. Panama has recently confirmed 100 deaths from the DEG contamination and another 200 are waiting to be confirmed. (more)
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From China to Panama, a Trail of Poisoned Medicine

Healthcare By WALT BOGDANICH AND JAKE HOOKER for the New York Times - The kidneys fail first. Then the central nervous system begins to misfire. Paralysis spreads, making breathing difficult, then often impossible without assistance. In the end, most victims die. Many of them are children, poisoned at the hands of their unsuspecting parents. The syrupy poison, diethylene glycol, is an indispensable part of the modern world, an industrial solvent and prime ingredient in some antifreeze. It is also a killer. And the deaths, if not intentional, are often no accident. Over the years, the poison has been loaded into all varieties of medicine — cough syrup, fever medication, injectable drugs — a result of counterfeiters who profit by substituting the sweet-tasting solvent for a safe, more expensive syrup, usually glycerin, commonly used in drugs, food, toothpaste and other products. Toxic syrup has figured in at least eight mass poisonings around the world in the past two decades. Researchers estimate that thousands have died. In many cases, the precise origin of the poison has never been determined. But records and interviews show that in three of the last four cases it was made in China, a major source of counterfeit drugs. (more)
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FDA Explains How Diethylene Glycol Entered The Supply Chain in Panama

Healthcare According to the FDA, this is what happened in Panama:
  • The pharmaceutical manufacturers of the syrups that contained contaminated glycerin did not perform full identity testing on the glycerin raw material, including tests to quantify the amount of DEG present and to verify the purity of the glycerin received.

  • The pharmaceutical manufacturers of the syrups containing contaminated glycerin relied on the certificate of analysis (COA) provided by the supplier.

  • The origin of the glycerin was not easily apparent from the COA. The COA obtained by the pharmaceutical manufacturers of the syrups was often a copy of a COA on the letterhead of the distributor and not the COA provided by the manufacturer of the glycerin. The chain of custody or distribution history of the glycerin was also not readily known because the glycerin may have been sold several times between its manufacture and its use in medicinal syrup or other drug product.

As a result of these practices, DEG-contaminated glycerin entered the pharmaceutical raw material supply chain. (more)

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FDA Advises Manufacturers to Test Glycerin for Possible Contamination

Healthcare Glycerin Contaminated with Diethylene Glycol (DEG) Remains a Potential Health Hazard to Consumers - The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG). DEG is a known poison used in antifreeze and as a solvent. Today, the agency is issuing guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products. At the present time, FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.
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Diethylene Glycol Claims Another Victim in Panama

Healthcare By Elizabeth González A. for the Panama America - Diethylene glycol has claimed another life in Panama. Mrs. Ana Brown, 66 years-old, died Sunday night in the Social Security hospital. She suffered from high blood pressure and was diabetic, and is on the official list of those effected by the mass poisoning. Three weeks ago her son Rogelio Blades told Panama America that during the most recent visit of doctors from the Centers for Disease Control (CDC) from the United States (included) his mother. With this most recent death, and considering that Panama's Health Minister Camilo Alleyne traveled to the CDC, the Panama America asked him about the state of health of the survivors. He only said that the CDC is preparing a report.
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Lawsuit Charges Spanish Company Rasfer International With Irregularities

Healthcare By Rafael Luna Noguera for La Prensa - Lawyers in Panama, Spain and the United States have discovered a series of apparent irregularities related to the business transaction made by the Spanish company Rasfer International in the sale of glycerin to Panama that turned out to be diethylene glycol, the poison that has caused the death of at least 100 people. The supposed crimes, contained in a lawsuit filed last week before the Spanish General Prosecutor, range from not disclosing a change in providers to obscure price fluctuations, which appear to be violations of regulations which apply to the commercial sale of products destined for human consumption. Rasfer charged $16,751 for the shipment.
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Almost 1,000 Cases of Dengue Reported in Panama

Healthcare Panama, Apr 26 (Prensa Latina) Almost 1,000 cases of dengue fever and two hemorrhagic cases were reported in the course of this year in Panama, despite campaigns for cleaning and prevention fostered by local sanitary authorities, said official sources here Friday. The Panamanian Public Health Ministry (MINSA) said the most affected regions are Panama City (528 cases) and San Miguelito (120). Later there are Cocle (102), Colon (61) and Chiriqui (45). Sanitary authorities are worried because of the beginning of the rain season in the nation, which allows a greater propagation of mosquito Aedes Aegypti, dengue fever transmitter. The Panamanian Public Health Ministry said that the island of Taboga, a place for fun and recreation, presented an infestation index of 21.4 percent, three times over normal. This institution started a national campaign at the beginning of this year, including fumigation and picking of garbage to fight the disease, incorporation of the civil society to the sanitary measures, participation of communication media to prevent the population and others. Official data said that more than 3,000 people were reported in Panama last year with classic dengue fever, and seven with hemorrhagic dengue fever, of whom one of them finally died.
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Qualified Chiropractic care now available in Panama

HealthcareIf you have been suffering with back and neck pains. Your answer is finally here. His name is Dr. Luis Enrique Ocón, and I met him for the first time in March. This Chiropractor is Licensed in the state of California, and he holds clinic once a month in Royal Center. Not since I was active duty and receiving quiropractic care at Wilford Hall Medical Center in Texas, have I felt such relief. Blue Cross will reimburse chiropractic care, and we are currently exploring reimbursement by the Department of Veterans Affairs. TRICARE however, does not reimburse chiropractic care cost. The bottom line is....if you have seen a Chiropractor in the past or have been considering seeing one, call me for more information. Nadine S. Kellys MEDSERV PANAMA, S.A. 223-1418
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US Air Force Doctors to Provide Health Clinic in Ngöbe Buglé

Healthcare By Urania Cecilia Molina for La Prensa - There's good news for the people who live in Valle Sarón, Miramar and Chiriquí Grande in the Comarca Ngöbe Buglé: Members of the United States Air Force will provide free medical attention from 18 to 27 April as part of the New Horizons exercise in cooperation with Panama's Health Ministry (MINSA). The people who live in these towns and villages often complain that they receive little or no medical attention. They lodged their most recent complaints on 4 April 2007 during the Comarcal Anticorruption Meeting, when they said that the government health clinics did not have any medicine, that there were no doctors or other healthcare personnel to attend them in remote areas. According to a press release from the Ministry of Healty, the health clinic will be provided by reservists from the US Southern Command and will include dental, optometry, gynecology, general medicine, a pharmacy, preventative health education, vaccinations, fitting and delivery of eyeglasses, and malaria testing. As part of the exercise engineers from the US Army South are building classrooms and healthcare centers. According to the 2000 National Census 110,080 people live in the Ngöbe Buglé region, and 90% are either poor or living in conditions of extreme poverty.
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Your TRICARE Benefits in Panama: Catastrophic Cap

Healthcare Mr. Winner, I am a Health Benefits Advisor for TRICARE Latin America and Canada. Last September Colonel Franco, other TRICARE Representatives and myself gave briefings to the TRICARE Retirees in Panama. We have since learned many retirees in Panama are confused about the TRICARE catastrophic cap. Col Colonel Franco asked me to I address this and enlist your help in getting this information out to the Tricare beneficiaries. I am attaching a short article on the subject we would like you to publish. Please let me know if this will be possible and thank you for your assistance. Sincerely, June Walling (Editor's Comment: Here you go. My pleasure, June.)

It has been brought to our attention that there has been some confusion in regards to the catastrophic cap. What does catastrophic cap mean to you? The National Defense Authorization Act for Fiscal Years 1988 and 1989 amended Title 10 of United States Code and placed fiscal year limits known as catastrophic caps on beneficiary liabilities for deductibles and cost-shares under the TRICARE Program. (more)

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