Milk Hypersensitivity

Allergic transfusion reactions (ATRs), a potentially life-threatening side effect of blood transfusions with unclear mechanisms, may be linked to food allergies in pediatric patients as per a recent study by scientists from Japan. They found that ATRs may be triggered by the presence of allergens in the donor's blood, influenced by their pre-donation diet. These findings could pave the way for safer blood transfusions through the development of preventive measures and countermeasures for ATRs. Allergic transfusion reactions (ATRs), a potentially life-threatening side effect of blood transfusions with unclear mechanisms, may be linked to food allergies in pediatric patients as per a recent study by scientists from Japan. They found that ATRs may be triggered by the presence of allergens in the donor's blood, influenced by their pre-donation diet. These findings could pave the way for safer blood transfusions through the development of preventive measures and countermeasures for ATRs. Blood transfusions are often life-saving procedures in various medical settings. They are required not only after severe blood loss due to surgery or trauma but also as standard treatment for certain blood disorders like anemia and sickle cell disease. However, blood transfusions can have serious side effects, with allergic transfusion reactions (ATRs) being particularly prevalent among children. Although scientists believe ATRs are caused by immunoglobulin E (IgE)-mediated type 1 allergy (or "immediate hypersensitivity"), the responsible allergens are not always known. Against this backdrop, a research team composed of Dr. Ryu Yanagisawa of Shinshu University Hospital, Japan, alongside Dr. Minoru Tozuka and Dr. Yasunori Ito from Nagano Children's Hospital, Japan, set out to find more answers. In their latest study, published online in the journal Allergy on January 11, 2024, the researchers focused their attention on what might have appeared to be an unlikely suspect. Dr. Yanagisawa, who led the study at the University's Division of Blood Transfusion, explains: "In our previous study, we found that pediatric patients with food allergies were characteristically more prone to ATRs. Considering that food allergies are also more prevalent in children, we decided to investigate whether the food the donor ate before giving blood could be associated with the development of ATRs in children with food allergies." Between May 2022 and December 2023, the researchers collected blood samples from over 100 pediatric patients with diagnosed food allergies toward either eggs, wheat, or milk. They also collected blood from two healthy donors before and after substantial ingestion of these food products and extracted the serum. Shortly after collecting blood from each allergic patient, the researchers conducted basophil activation tests (BATs) by exposing the sample to the corresponding sera. As the name implies, these tests assess the activation of basophils, a particular type of white blood cell that is strongly involved in allergic reactions. Interestingly, in patients with egg allergy, BAT levels were significantly higher when the blood was exposed to the serum of donors who had ingested eggs. Moreover, serum obtained from blood donor samples collected four hours after egg ingestion resulted in markedly higher BAT levels than those collected two hours after egg ingestion. In contrast, the results for milk and wheat were more varied, with BAT levels only being elevated after exposure to the serum of one of the two donors. To gain deeper insights and lend more weight to the results, the researchers decided to run BAT tests with sera from sixteen additional donors. "Although some differences were observed among donors, blood samples obtained after egg ingestion generally activated basophils in cases of egg allergy with high egg white-specific IgE levels," comments Dr. Yanagisawa. "Similarly, elevated BAT levels in patients with milk and wheat allergies were also associated with allergen-specific IgE levels." Overall, the evidence obtained through this study strongly suggests that ATRs could be triggered by the food consumed by donors prior to a blood donation. Although further analyses and experiments will be needed to confirm this with more certainty, these efforts constitute a necessary first step towards elucidating the mechanisms underlying ATRs. "In future, it could be possible to predict in advance who is likely to suffer from an ATR. Given enough time, preventive measures and countermeasures to ATRs could be developed, leading to safer blood transfusions," concludes Dr. Yanagisawa. It is hoped that this study puts scientists on the right path toward cracking the mysteries of ATRs to improve the outcome of blood transfusions.

DBV Technologies hopes to complete enrollment in two supplemental safety trials of a peanut allergy therapy this year. DBV Technologies, a French biotech working on a treatment for food allergies, says it's running out of cash. The disclosure came via a going concern note in the company’s fourth-quarter and full-year 2023 earnings report on Friday, with DBV saying it doesn’t have enough money to keep the lights on for a full 12 months. DBV says it has until the very end of the year based on the $141.4 million in cash reported as of the end of December 2023.  To persevere, the biotech will look to raise more money via debt and equity offerings. DBV’s cash reserves fell by nearly $68 million in 2023, with most of the money going toward R&D.   Much of the biotech’s focus centers on lead peanut allergy treatment DBV712, with two phase 3 safety trials ongoing in kids. The goal is to complete enrollment in two supplemental six-month safety trials this year, despite experiencing delays that were attributed to new clinical trial rules in Europe.  “We expect good momentum regarding Vitesse recruitment in the next several months and last subject screened by Q3 2024,” DBV CEO Daniel Tassé said in a release. The late-stage development work makes DBV’s current cash crunch all the more perilous, given how close the company potentially is to the market.  In addition to wrapping up enrollment in the two COMFORT trials, DBV expects to have three-year data from an efficacy trial in toddlers 1-3 years old. A sibling trial for kids 4-7 years old is slated to screen its last patient by the third quarter of 2024. That study, named VITESSE, was previously on an FDA partial hold while the company and regulators worked on an updated trial protocol.  Should DBV strengthen its balance sheet, there are two additional phase 2 trials waiting in the wings for runner-up med DBV135, which is in development for milk allergies and eosinophilic esophagitis.

PARSIPPANY, N.J.--( BUSINESS WIRE )--Reckitt/Mead Johnson Nutrition (MJN), a producer of nutrition products, announced today that it has voluntarily chosen to recall from the U.S. market select batches of Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans, due to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria. Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body. Nutramigen in 12.6 and 19.8 oz containers was manufactured in June 2023 and distributed primarily in June, July, and August 2023. Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed. There are no reports of illnesses or adverse events to date. The products were distributed through retail stores nationwide. The batches in question can be identified by the batch code on the bottom of the can. The following recalled product batch codes and can size associated with each batch were distributed in the U.S.: ZL3FHG (12.6 oz cans); ZL3FMH (12.6 oz cans); ZL3FPE (12.6 oz cans); ZL3FQD (12.6 oz cans); ZL3FRW (19.8 oz cans); and ZL3FXJ (12.6 oz cans). The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”. No other U.S. distributed Nutramigen batches or other Reckitt products are impacted. Reckitt/Mead Johnson Nutrition manufactured additional products during this finished product campaign and distributed them outside of the U.S. Reckitt/Mead Johnson Nutrition will be contacting the regulatory authorities in each of those countries to determine the proper disposition of those products. If parents have any questions, they should consult with their pediatrician or contact us at 866-534-9986 24/7 or by email at consumer.relations@rb.com We are committed to the highest level of quality and safety and it is for this reason that we have taken this measure. Other testing of the batches in question tested negative for Cronobacter and other bacteria. The health and safety of infants is our highest priority. All of our products undergo rigorous and industry-leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. Food and Drug Administration. It is for this reason that we have confidence in the safety and quality of every infant formula we make. What Consumers Should Do if They Purchased This Product Consumers who purchased Nutramigen should check the bottom of the can to identify whether the batch number is affected. Product with the batch codes listed above should be disposed of, or contact us for a total refund. Please contact us at 866-534-9986 or by email at consumer.relations@rb.com and we will help verify if this product was impacted. If you have any concerns, contact your health care provider. For more information, please visit us at www.enfamil.com .