FDA: PDX Aromatics Recalls Kratom Powder Because Of Possible Health Risk

PDX Aromatics of Portland, Oregon DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, has initiated a recall of certain kratom-containing powder products because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Learn more

Sexually-transmitted Zika case in L.A. County

Los Angeles County officials last week reported that a woman had been infected with the Zika virus by her partner, in the first case of sexually transmitted Zika virus in the county. A man who lives in L.A. County traveled to Mexico and became infected with Zika in early November, and shortly afterward his female partner, who didn’t travel to Mexico, also developed the infection, officials said. Learn more

Opioids now kill more people than breast cancer

(CNN)More than 63,600 lives were lost to drug overdose in 2016, the most lethal year yet of the drug overdose epidemic, according to a new report from the National Center for Health Statistics, part of the US Centers for Disease Control and Prevention.

Most of those deaths involved opioids, a family of painkillers including illicit heroin and fentanyl as well as legally prescribed medications such as oxycodone and hydrocodone. In 2016 alone, 42,249 US drug fatalities — 66% of the total — involved opioids, the report says. That’s over a thousand more than the 41,070 Americans who die from breast cancer every year. Learn more

Oregon Health Authority: OSU requires vaccinations in light of sixth meningococcal disease case

Health officials today reported a sixth case of meningococcal disease infecting a student enrolled at Oregon State University in Corvallis, and are encouraging undergraduate students during winter break to receive vaccinations for meningococcal B disease.

“Oregon State University takes the health and welfare of its students, employees and the general public very seriously,” said Steve Clark, OSU vice president for university relations and marketing.

“Effective immediately, Oregon State University will require all of its Corvallis students 25 and younger to be vaccinated for meningococcal B disease by Feb. 15,” he said. “Prior to this latest case, vaccinations were encouraged for all OSU students 25 years and under, but required for all incoming first-year students and transfer students.” Learn more

Allergic to eggs? You can now get the flu shot, new guidelines say

Most flu vaccines administered today are manufactured using chicken eggs and contain trace amounts of a protein called ovalbumin. But a paper published Tuesday in the Annals of Allergy, Asthma and Immunology found the flu shot to be safe and recommended its use for people who are allergic to eggs. “People with egg allergy of any severity can receive the influenza vaccine without any special precautions,” said Dr. Matthew Greenhawt, the paper’s lead author and chairman of the American College of Allergy, Asthma and Immunology Food Allergy Committee. The new findings mean that even more people will be able to get their recommended flu shot without sacrificing peace of mind. Learn more 

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for moderate-to-severe opioid use disorder.  The U.S. Food and Drug Administration today approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days. Read the full news release.

FDA: Virginia Diner, Inc. Issues Allergy Alert on Undeclared Peanut Allergen in Chocolate Covered Cashews 10 oz. cans

Virginia Diner, Inc. is voluntarily issuing a recall of 10 oz. cans of Plow & Hearth Chocolate Covered Cashews at Plow & Hearth’s locations and nationwide (Mail Order) as a precaution because they may contain peanuts and peanut allergens. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.  A label mix up was discovered by a consumer who received and opened a Cashew Tower Set (3 individual cashew cans) of which one can, the 10 oz. Chocolate Covered Cashews, were found to have Salted Peanuts.

The Virginia Diner, Inc. is working with the U.S. Food and Drug Administration in administering this voluntary recall.  The Virginia Diner has not received any reports of illness or injury to date regarding this product. Learn more

FDA: Biotin (Vitamin B7): Safety Communication – May Interfere with Lab Tests

The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.

Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results. The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.

Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications. The FDA has received a report that one patient taking high levels of biotin died following falsely low troponin test results when a troponin test known to have biotin interference was used.

The FDA is aware of people taking high levels of biotin that would interfere with lab tests. Many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis (MS). Biotin levels higher than the recommended daily allowance may cause interference with lab tests.

Patients and physicians may be unaware of biotin interference in laboratory assays. Even physicians who are aware of this interference are likely unaware as to whether, and how much biotin, patients are taking. Since patients are unaware of biotin interference, patients may not report taking biotin supplements to their physicians, and may even be unware they are taking biotin (e.g., when taking products generally labeled for their benefits to hair and nails).

The FDA is working with stakeholders to better understand biotin interference with laboratory tests, and to develop additional future recommendations for safe testing in patients who have taken high levels of biotin when using laboratory tests that use biotin technology.

The FDA is monitoring reports of adverse events associated with biotin interference with laboratory tests and will update the public if significant new information becomes available.

Learn more