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.
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
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.
Asmar’s Mediterranean Food, Inc. of Alexandria, Va. is recalling one lot of Asmar’s Original Hommus because the product has the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections to individuals with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Read more.
The Centers for Disease Control and Prevention (CDC) today issued updated interim clinical guidance for health care providers caring for infants born to mothers with possible Zika virus infection during pregnancy. This update includes information that has become available since the August 2016 release of the previous guidance.
Zika virus continues to be a public health threat to pregnant women and their infants. Despite the lower number of Zika cases in 2017 than at this time during 2016, Zika cases continue to be reported by many countries around the world. Zika virus infection during pregnancy can cause serious damage to the brain of the developing fetus. It can lead to congenital Zika syndrome in babies, a pattern of birth defects that includes brain abnormalities, vision problems, hearing loss, and problems moving limbs. Babies with congenital infection may also appear healthy at birth but have underlying brain defects or other Zika-related health problems.
“There’s a lot we still don’t know about Zika, so it’s very important for us to keep a close eye on these babies as they develop,” said CDC Director Brenda Fitzgerald, M.D. “Learning how best to support them will require a team approach between healthcare providers and families.”
The updated recommendations emphasize that it is important for pediatric health care providers to assess risk of congenital Zika virus infection, to communicate closely with obstetrical providers, and to remain alert for any problems that may develop in infants without birth defects born to mothers with possible Zika virus exposure during pregnancy.
General Mills is voluntarily recalling two days of production of Cascadian Farm Organic Cinnamon Raisin Granola cereal because of an undeclared allergen. There have been no reports of illness.
Cascadian Farm Organic Cinnamon Raisin Granola cereal produced on July 15 and 16, 2017 is being recalled because the product may contain almonds, an undeclared nut allergen. More
FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.
In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach. In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.
To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding. More
A new CDC study published today in Clinical Infectious Diseases reported that vaccination with whooping cough vaccine, Tdap, during the third trimester of pregnancy prevented more than three out of four (78 percent) cases of whooping cough (also known as pertussis) in babies younger than two months. However, only 49 percent of pregnant women who delivered between fall 2015 and spring 2016 received the vaccine. CDC recommends women get Tdap during each pregnancy to provide critical short-term protection to babies when they are most at risk for this life-threatening illness. More
lu symptoms can be more severe when you’re pregnant, landing women in the hospital, threatening their lives and even leading to preterm birth or miscarriage. The virus is a risk to the woman and the baby.
The Texas Department of State Health Services, with assistance from CDC, is investigating Brucella RB51 exposures and illnesses that may be connected to the purchase and consumption of raw (unpasteurized) milk from K-Bar Dairy in Paradise, Texas. Symptoms of brucellosis can include: fever, sweats, malaise, anorexia, headache, fatigue, muscle & joint pain, and potentially more serious complications (e.g., swelling of heart, liver, or spleen, neurologic symptoms). Read the full CDC Health Advisory.