November 05, 2018

Good Morning,

Technology is great when it works, but can be extremely hazardous when it doesn't, especially when it comes to ones health. Check our first article on the FDA recalling devices over inaccurate warfarin test results.

Learn about this and more interesting stories from the scientific community in today's issue.

Until Next Time,
Erin

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*-- FDA recalls devices over inaccurate warfarin test results --*

The U.S. Food and Drug Administration has recalled test strips for levels of the blood thinner warfarin because they may provide inaccurate results.

The federal agency said in an advisory on Thursday that Roche Diagnostics' at-home or office medical devices should not be relied upon to adjust drug usage. The Class I recall is the FDA's most serious designation, meaning these devices may cause serious injuries or death.

Rather than relying on these test strips, patients should use an alternative meter device, or blood drawn from a vein and have levels measured by a laboratory test, the FDA said.

The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips distributed nationwide from Jan. 12 through Monday. The test strips are used with these devices: CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST and CoaguChek Vantus. The affected lots numbers are included in the advisory.

The company said it plans to provide new batches of re-calibrated test strips to customers by the end of November.

"These strips are widely used and we are working diligently to warn health care providers and the public about the dangers associated with this recall," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients."

Warfarin, which is known by the brand names Coumadin and Jantoven, is used to prevent and treat blood clots for certain types of irregular heartbeats, blood clots in the legs or lungs, or certain medical device implants such as artificial heart valves.

Of particular concern, the FDA said, are individuals at increased risk because of mechanical heart valves, irregular heartbeat or those with a recent blood clot. Problems with the CoaguChek XS PT test strips are not likely to be evident to the patient, the FDA said.

Regular monitoring is required while their blood needs to clot.

Results are provided with fingerstick blood drawn from a lancet using a test meter at home or in a doctor's office similar to devices that test blood glucose levels.

The meter reads the test strip, measures how long it takes the blood to clot and provides a result based on a standardized calculation in the form of the International Normalized Ratio.

Roche Diagnostics notified the FDA of 90 medical device reports and two serious patient injuries involving strokes.

The company said the problem is linked to a recent re-calibration of the test strips to a different international standard from earlier this year. The new tests strips will be distributed based on the previous international standard.

The FDA is urging device users are urged to contact their health care provider to get information about alternative test methods and to address questions regarding their individual testing schedule.

*-- Newly discovered toxic pollutant found in homes, environment --*

People are likely being exposed to a newly detected toxic pollutant by breathing contaminated dust or through skin contact, according to a study.

Researchers at Indiana University discovered high levels of the chemical, tri(2,4-di-t-butylphenyl) phosphate, or TDTBPP, in homes, an electronic waste recycling facility and in the natural environment. Their findings were published Tuesday in Environmental Science & Technology.

The compound is part of the family of toxic organophosphates, which is the most widely used class of insecticides, but is also used as a flame retardant, a plasticizer in consumer products and can be formed when other chemicals degrade.

"We were looking at flame retardants and found this compound for the first time," Dr. Marta Venier, a scientist at the IU School of Public and Environmental Affairs, told UPI. "In all samples we looked for we found it in flame retardants and as a plasticizer."

"This compound is potentially a concern because of exposure in homes and occupational settings," she added.

Environmental chemists have had difficulty tracking down pollutants in the environment and what kind of effects they might cause because common commercial chemicals, including TDTBPP, are not subject to regulatory scrutiny under the U.S. Toxic Substances Control Act unless they are used for new purposes.

"The fact that this potentially toxic chemical is so abundant, but was previously unknown, is another example of the ineffective management of chemicals in the United States," Venier previously said in a press release.

Researchers believe many chemicals go undetected until a general environmental scan is performed.

This is what Indiana University scientists performed using high-resolution mass spectrometry. They studied dust samples from an e-waste dismantling facility in Ontario, Canada. E-waste recycling facilities often include similar TDTBPP chemicals used in the production of plastics, wires, printed circuit boards and electronic equipment.

Researchers also studied dust from 20 residential homes in Ontario, as well as outdoor samples from the Chicago Ship and Sanitary Canal, Indiana Harbor water filters and filters from high-volume air samplers deployed in Chicago. They measured amounts of TDTBPP in ambient air, water and sediment.

Especially high levels of TDTBPP were found in house dust.

"Our research is the first step," Venier said. "Now that we know that TDTBPP is prevalent, especially in homes, scientists can flag it for further study and focus on understanding the effects of TDTBPP on people."


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